Metastatic CancerPhase 2NCT03299452
Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor
A Phase 2 study testing Non Chemotherapy, Chemotherapy and target therapy and Chinese herb medicine in people with Metastatic Cancer, run by Haining Health-Coming Biotech Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Non Chemotherapy, Chemotherapy and target therapy and Chinese herb medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced recurrent or metastatic malignant tumor confirmed by pathological diagnosis;
- At least one measurable malignant lesion;
- Failed previous standard treatment or with tumor recurrence, and no standard therapeutic regimen available;
- No radiation therapy within last four weeks or recovered from last radiation related acute complication, if applicable; prophylactic brain radiation therapy or palliative radiation treatment for bone metastasis is acceptable;
- No gender requirement and must be no younger than18 years old;
- ECOG PS: score 0-2;
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- Life expectancy more than three months;
- Patient's organ function level should meet these criteria:
- CBC should meet these criteria: ANC≥1.5×109 /L，PLT≥100×109/L，Hb≥ 100 g/L; (2) Chemistry should meet these criteria: TBIL<1.5×ULN，ALT、AST< 2.5×ULN（if with liver metastasis ALT、AST<5×ULN） BUN and Cr ≤1×ULN or Cr clearance ≥50ml/min（Cockcroft-Gault formula） 9. Agree to use appropriate contraceptive measure during the study period and until 8 weeks after the last study drug is given. Or patient has been surgically sterilized.
- 10. Qualified candidate should voluntarily participate this study, sign informed consent forms and be compliant with the study protocols and follow-up visit(s).
Who cannot join
- Symptomatic brain metastasis (could still enroll into the study if treatment finished 21 days prior to the enrollment and the patient is stable, but brain MRI, CT or angiogram is needed to rule out no intracranial hemorrhage)
- Following cardiac disease: second-degree or above cardiac ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval male>450 ms, female>470ms), according to NYHA criteria, III to IV cardiac insufficiency, or echocardiogram reveals left ventricular ejection fraction (LVEF) <50%;
- History of pulmonary interstitial lung disease or active interstitial lung disease;
- Coagulation dysfunction (INR >1.5 or PT>ULN+ 4sec, or PTT>1.5 ULN), with bleeding tendency or currently receiving thrombolysis therapy or anticoagulation treatment;
- Clinical bleeding episode or bleeding tendency within past three months, such as GI bleeding, hemorrhagic gastric ulcer, stool guaiac++ positive, or with vasculitis；
- Arterial or venous thrombosis within last 12 months, such as various types of CVA, DVT or PE patients;
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- Known hereditary or acquired bleeding or hypercoagulable state (such as hemophilia, coagulating dysfunction, thrombocytopenia, hypersplenism);
- Major surgery, trauma, fracture or ulcer within past 4 weeks;
- Active infection requiring antibiotics, antifungal or antiviral treatment;
- Patient has a history of psychiatric medication abuse and cannot be abstinent from the psychiatric medication, or with mental disorder;
- Participation of other cancer chemotherapy clinical study within past 4 weeks;
- History of uncured coexisting cancer, no including cured basal cell carcinoma, cervical cancer in situ, or superficial bladder cancer;
- Pregnant or breast feeding women; fertile patients no willing or able to take effective contraceptive measures;
- Any circumstances that might affect the proceeding of the clinical trial and/or research result analysis, as determined by the clinical investigator(s).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of medicine
Hangzhou, Zhejiang, 310000
Haizhou Lou, MD, 86-571-86006926, louhz09@aliyun.com
Ming Xu, 86-571-86006811, xuminghnu@126.com
About this study
Official title: Clinical Studies by Using Alphacait to Screen Drug Combinations for Advanced Solid Tumor
This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
Read the detailed description
Tumor heterogeneity leads to a significant difference in the rate of response to drugs in patients with the same pathological type. According to the information, the current initial effective rate of domestic and foreign chemotherapeutic single drug is no more than 30%, even if treated with repeated medication or replacement treatment program, the responsive rate is generally not more than 10%. This heterogeneity of tumor is the biological basis of precision medicine, and how to predict cancer drug sensitivity is a clinical need to solve the practical problems.
Traditional PDX (patient-derived engraft) technology utilizes patient's fresh tumor tissue (containing tumor cells, stromal cells and vascular components), and inoculates in immunodeficient mice to establish mouse tumor model. This method can better reflect the true biological characteristics of tumor, while the mouse tumor tissue can be continuously passed on, and greatly facilitate tumor biology research. According to the transplant site it can be divided into orthotopic transplantation and ectopic transplantation (mostly subcutaneous or renal transplantation). However, the traditional PDX model has its disadvantage of low success rate and time consuming. Most of the tumor matrix after transplantation can be replaced by the corresponding components in mice, leading to differences in the biological properties of the original tumor.
In view of this imperfection, we developed an optimized drug selection model based on the Alphacait screening system that combines artificial intelligence, synthetic lethal and combinational chemistry, which allows rapid selection of candidates from millions of drug combinations. We want to provide physicians with individualized drug therapy through a new in vitro and in vivo drug-sensitive screening technique, to achieve rapid and accurate selection of cancer clinical treatment.
In order to achieve the two key requirements of tumor tissue culture system in vitro, the establishment of tumor microenvironment we introduced the millimeter-sized microbeads, based on combinatorial chemistry in the culture medium. The surface of the microbeads is coated with small molecules that can specifically absorb high levels of metabolites secreted by the tumor cells into the matrix, thereby mimicking in vivo circumstances. In short, we innovatively applied microbeads technology to solve the inherent limitations of 3D organoid culture - no blood circulation in vitro.
Purpose and design Primary endpoint: progression-free survival (PFS) Secondary endpoints: overall survival (OS); disease control rate (DCR), objective response rate (ORR); safety; blood test and gene test in the aspect of biomarkers. Expectations of exploratory markers for this study include the status of exploratory biomarkers associated with immunohistochemistry (IHC) or quantitative reverse transcription polymerase chain reaction (qRT-PCR), a new generation sequencing method (NGS), Nanostring technique and / or other methods to evaluate archived and/or newly acquired tumor tissue, as well as its association with disease status and/or (Including but not limited to somatic mutations and other exploratory markers) according to qRT-PCR and NGS techniques, and to evaluate the relationship between the therapeutic response, the status of the biomarker during exploratory treatment and during treatment, and the evaluation of plasma, serum or whole blood samples (including but not limited to somatic mutations and other exploratory markers) The association of the above markers with disease status and / or therapeutic response.
Research design This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on the Alphacait screening system in subjects with advanced malignant tumor.
List of drugs used by the Alphacait screening system is as follow:
Non chemotherapy drug
Albendazole Tablets, Alfacalcidol Soft Capsules, Aripiprazole Tablets, Anastrozole Tablets, Azithromycin, Acyclovir Dispersible Tablets, Aztreonam, OLanzapine Tablets, Omeprazole Enteric-coated Capsules, Ornidazole and Sodium Chloride Injection, resveratrol, citicoline sodium injection, Bevacizumab，Avastin, Phenobarbital, Amlodipine Besylate Tablets, phenytoin sodium tablet, Piroxicam tablets, Allopurinol tablets, Propylthiouracil Tablets, Sodium Valproate for Injection, Nuprin Tablets, Goserelin Acetate Sustained-Release Depot, Zoladex, Megestrol Acetate Dispersible Tablets, Prednisone Acetate Tablets, Desmopressin Acetate Injection, Low-molecular-weight Heparin Sodium Injection, Digoxin Tablets, Dexamethasone Sodium phosphate Injection, Bacillus Licheniformis Capsule, tabellae paracetamol, Levodopa and Benserazide Hydrochloride Tablets, Domperidone Tablets, Metformin, Famotidine tablets, Fenbendazole, Nitrofurantoin Enteric-coated Tablets, Fluconazole and Sodium Chloride Injection, Haloperidol Injection, Flupentixol and Melitracen Tablets, Compound Zedoary Turmeric Oil Suppositories, Compound Sulfamethoxazole Injection, Compound Hypotensive Tablets, Bisoprolol Fumarate Tablets, Quetiapine Fumarate Tablets, Injection Mannitou, Heparin sodium, Bismuth Potassium Citrate Tablets, Banan tablet, Erythromycin enteric capsules, Metoprolol succinate sustained-release tablets, Warevan tablet, Huaier granule, Cyclosporine, Progesterone injection, Gabapentin capsules, Mebendazole Chewable Tablets, Apatinib Mesylate, Phentolamine Mesylate Injection, Imatinib Mesylate, Neostigmine Methylsulfate Injection, Imatinib Mesylate Tablets, Thiamazole Tablets, Metronidazole, Colloidal Bismuth Pectin Capsules, Metoprolol Tartrate Tablets, Carbamazepine Tablets, Captopril Tablets, Clarithromycin Sustained-release Tablets, Clindamycin Phosphate Injection, Lamictal, Letrozole Tablets, Lara chips, Tripterygium Glycosides, Atorvastatin, Ribavirin injection, Rifampicin Capsules, Risperidone Tablets, Primaquine Diphosphate, Chloroquine Phosphate Tablets, Amikacin Sulfate Injection, Atropine sulphate injection, Magnesium sulfate injection, Azathioprine Tablets, Sulfasalazine Enteric-coated Tablets, Roxithromycin Soft Capsules, Clozapine Tablets, Desloratadine Tablets, Flupirtine Maleate, Fluvoxamine Maleate Tablets, Chlorphenamine Maleate Tablets, Enalapril Maleate Tablets, Meloxicam, Mesalazine Enteric-coated Tablets, Mirtazapine, Naproxen Tablets, Nikethamide Injection, Nimodipine Injection, Nitrendipine Tablets, Norfloxacin Capsules, Hydroxycarbamide Tablets, Artemisinin, Benzylpenicillin sodium, Hydrocortisone Injection, Citalopram Hydrobromide Tablets, Gentamicin, Colchicine Tablets, Doxifluridine Capsules, Deslanoside Injection, Ciprofloxacin Lactate and Sodium Chloride Injection, Celecoxib Capsules, Trifluoperazine, Tetrastigma hemsleyanum Diels et Gilg, Thalidomide Tablets, Sulpiride Tablets, Diclofenac Potassium Capsules, Clostridium butyricum TO-A, Dihydroartemisinin and Piperaquine Phosphate Tablets, Tetracycline Tablets, Lithium Carbonate Sustained-release Tablets, Tegafur Injection, Teicoplanin, Tinidazole and Sodium Chloride Injection, Cefoxitin, Ceftizoxime Sodium, Topiramate Tablets, Vancomycin, Tretinoin Tablets, Vemurafenib, Vitamin A, Vitamin B2 Tablets, Vitamin D2 Injection, Cimetidine Tablets, Cimetidine Injection, Nifedipine Sustained Release Tablets, Nitroglycerin Injection, Isosorbide Dinitrate Injection, Valsartan Dispersible Tablets, Simvastatin Tablets, Thymalfasin, Ursodeoxycholic Acid, Folic acid calcium salt hydrate, Amitriptyline Hydrochloride Tablets, Bupropion Hydrochloride Sustained-Release Tablets, Amiodarone Hydrochloride Tablets, Ondansetron Hydrochloride Injection, Betahistine Hydrochloride Injection, Diphenhydramine Hydrochloride Injection, Bupropion Hydrochloride Injection Tablets, 3-Hydroxytyramine hydrochloride, Doxepin Hydrochloride, Flunayizine Hydrochloride Capsules, Prozac, Metoclopramide Dihydrochloride Injection, Arginine Hydrochloride Injection, Clindamycin Hydrochloride Injection, Raloxifene Hydrochloride Tablets, Ranitidine Hydrochloride Capsules, Lidocaine Hydrochloride Injection, Lobeline Hydrochloride Injection,, Chlorpromazine, Clomipramine Hydrochloride Tablets, Omeprazole Magnesium Enteric-coated Tablets, Mexiletine Hydrochloride Tablets, Paroxetine Hydrochloride Tablets, Procaine Hydrochloride for Injection, Trazodone Hydrochloride Tablets, Daunorubicin hydrochloride, Cyproheptadine Hydrochloride Tablets, Sertraline Hydrochloride Tablets, Tamsulosin Hydrochloride Sustained Release Capsules, Terazosin Hydrochloride Tablets, Verapamil Hydrochloride Tablets, Venlafaxine Hydrochloride Capsules, Raceanisodamine Hydrochloride Injection, Berberine Hydrochloride Tablets, Ethambutol Hydrochloride Tablets, Levofloxacin Hydrochloride for Injection, Itraconazole, Ivermectin, IPTG；Isopropyl-β-D-thiogalactoside, Isopropyl-beta-D-thiogalactopyranoside, Isoniazid Tablets, Indapamide Tablets, Indomethacin Enteric-coated Tablets, Amoxicillin Sodium and Clavulanate Potassium for injection, Azithromycin for Injection, Acyclovir for Injection, Ampicillin Sodium Injection, Omeprazole Sodium for Injection, Oxacillin Sodium for Injection, Biapenem for Injection, Benzathine Penicillin For Injection, Sodium Valproate for Injection, Ganciclovir, Fosfomycin Sodium for Injection, Asparaginase, Urokinase for Injection, Piperacillin Sodium for Injection, Artesunate for Injection, Sodium Nitroprusside, Diltiazem Hydrochloride for Injection, Recombinant Human Interferon gamma for Injection, Levobupivacaine, Levothyroxine Sodium Tablets, Levofloxacin Tablets
Chemotherapy and target therapy drugs
Aidi injection, Oxaliplatin for Injection, Epirubicin, Dacarbazine, Dabrafenib, mesylate, Dabratinib, Dasatinib Tablets, Sorafenib Tosylate Tablets, Doxorubicin, Docetaxel, 5-Fluorouracil, Juyuansuan Tamoxifen, Cino bufotalin, Cyclophosphamide, Gefitinib (pure) powder, Gemcitabine hydrochloride, Methotrexate, Carboplatin, Capecitabine, Kanglaite Injection, Raltitrexed, Mabthera, Lobaplatin for Injection, Mitoxantrone, Nedaplatin, Mercaptopurine, Cisplatin, Mitomycin for Injection, Tacrolimus, Tegafur, Gimeracil and Oteracil Potassium, Temozolomide, Cetuximab Solution for Infusion, Lobaplatin for Injection, Mitoxantrone, Nedaplatin, Mercaptopurine, Cisplatin, Mitomycin for Injection, Tacrolimus, Tegafur, Gimeracil and Oteracil Potassium, Temozolomide, Cetuximab Solution for Infusion
Chinese Herb Medicine
English Name Latin Name Job's tears seed Coicis Semen, Japanese Ardisia Herb Japanese Ardisia Herb, White Hyacinth Bean Semen Dolichoris Album, Spreading Hedyotis Herb Hedyotis diffusa, Willowleaf Swallowwort Rhizome Rhizoma Cynanchi Stauntonii, Large head Atractylodes Rh Rhizoma Atractylodis Macrocephalae, Sessile Stemona Root Japanese Stemona Root, Lily Lilium brownii var. viridulum, Seman Platycladi Seman, Isatis root Isatis tinctoria, Herba Lobeliae Chinensis Lobelia chinensis Lour, Pinellia ternata Pinellia ternata (Thunb.) Breit, Scutellaria barbata Scutellaria barbata, CoasiaI GIehnia Root Glehnia littoralis, Fritillary fritillary, Ficus pumila Linn Ficus pumila, Seed-coat of Hyacinth Dolichos, Areca Seed, Betel Nut Semen Arecae, Malaytea Scurfpea Fruit Fructus Psoraleae, Semen raphani , Silkworm shit Faeces Bombycis, Siberian Cocklour Fruit Fructus Xanthii, Rhizome of Swordlike Atractylodes Rhizoma Atractylodis, Root of Chinese Thorowax Radix Bupleuri, Radices paeoniae rubra Paeoniae Rubra Radix, Dan - shen Root Salviae Miltiorrhizae Radix, Tree Peony Root - bark Moutan Radicis Cortex, Chinese Goldthread Rhizome Coptidis Rhizoma, Skunk Bugbane Rhizome Cimicifugae Foetidae Rhizoma, Coix seed Semen Coicis Szechwan Chinaberry Fruit Fructus Meliae Toosendan, Radix Cyathulate Radix Cyathulae, Common Andrographis Herb Herba Andrographis, Radix et Caulis Acanthopanacis Senticosi Radix et Caulis Acanthopanacis Senticosi, Japanese Thistle Herbor Root Herba seu Radix Cirsii Japonici, Indigowoad Leaf, Leaf of Indigowoad Folium Isatidis, Danshen Root, Root of Dan-shen Salviae Miltiorrhizae Radix et Rhizoma, Root of Pilose Asiabell Radix Codonopsis, Fructus Oryzae Germinatus Fructus Oryzae Germinatus, Humifuse Euphorbia Herb Herba Euphorbiae Humifusae, Chinese Waxgourd Peel Exocarpium Benincasae, Waxgourd seed Semen Benincasae, Rabdosia rubesens,hamst Rabdosia rubescens, Rhioxma Curcumae Aeruginosae Rhizoma Curcumae, Divaricate Saposhnikovia RootRadix Saposhnikoviae, Indian Buead Poria, Pine among the Indian Bread, Blighted Wheat Fructus Tritici Levis, Radix Glycyrrhizae Radix Glycyrrhizae, Toad skin, Perfoliate Knotweed Herb Polygonum perfoliatum, Ligusticum sinense Oliv Rhizoma Ligustici, Barbary Wolfberry Fruit Fructus Lycii, Herba Pogostemonis Herba Pogostemonis, Sargassum Sargassum, Yerbadetajo Herb Herba Ecliptae Eclipta prostrala, Terminalia chebula Retz, Taxus chinensis Taxus chinensis (Pilger) Rehd, Flos Carthami Flos Carthami, Root of Kirilow Rhodiola Herba Rhodiolae, Figwortflower Picrorhiza Rhizome Rhizoma Picrorhizae, Polygonum cuspidatum Rhizoma Polygoni Cuspidati, Pricklyash Peel Pericarpium Zanthoxyli, Talcum Talcum, Exocarpium Citri Grandis Exocarpium Citri Grandis, Phellodendron Chinese Schneid Cortex Phellodendri, Manyflower Solomonseal Rhizome Rhizoma Polygonati, Radix Astragali Radix Astragali seu Hedysari, Radix Scutellariae, Flos Celosiae Cristae Flos Celosiae Cristatae, Suberect Spatholobus Stem Caulis Spatholobi, Rhizoma Curcumae Longae Rhizoma Curcumae Longae, Christina Loosestrife HerbHerba Lysimachiae, Japanese Honysuckle Flower Bud Flos Lonicerae, Cherokee Rose Fruit Fructus Rosae Laevigatae, Chrysanthemum flower Flos Chrysanthemi, Spikemoss Herba Selaginellae, Cassia seed Semen Cassiae, Lightyellow sophora root Radix Sophorae Flavescentis, Kelp Laminariae Thallus, Semen Litchi Semen Litchi, Chinese trumpet creeper Campsis grandiflora, Diverse Wormwood Herb Herba Artemisiae Anomalae, Radix Gentianae Gentiana Scabra Bunge, Reed Rhizome Stemmacanthae Unifori Radix, Caulis Trachelospermi Trachelospermi Jasminoidis Caulis, Lv Bean Spermodermis Phaseoli Radiati, European Verbena Herb Herba Verbenae Officinalis, Herba Portulacae Portulaca oleracea L, Radix Ophiopogonis Ophiopogonis Radix, Fructus Hordei Germinatus Hordei Germinatus Fructus, Concha Ostreae Concha Ostreae, Costustoot, Common Vladimiria Root Aucklandiae Radix, Fructus Ligustri Lucidi Ligustri Lucidi Fructus, Fortune Eupatorium Herb Eupatorii Fortunei Herba, Folium Eriobotryae Eriobotryae Japonicae Folium, Dandelion Herba Taraxaci, Flower of Shepherdspurse Capsella bursa-pastoris (L.)Medic), Rhizoma Homalomenae Rhizoma Homalomenae, Gordon Enryale Seed Euryales Semen, Radix Gentinae Gentianae Macrophyllae Radix, Cortex Fraxini Fraxini Cortex, Caulis SinomeniiI Caulis Sinomenii, Semen Celosiae Celosiae Argenteae Semen, Herba Dianthi Dianthi Superbi Herba, Caulis Lonicerae Lonicerae Caulis, Cortex CinnamoniCinnamomi Cassiae Cortex, Rhizoma Srarganii Rhizoma Sparganii, Sanchi Panax pseudo-ginseng var, Radix tetrastigme Tetrastigma hemsleyanum Diels et Gilg, Folium Mori Mori Folium, Chinese yam Dioscorea opposite, Amorphophallus rivieri Durieu Amorphophallus rivieri Durieu, Snake venom, Snake Slough Serpentis Periostracum, Rhizoma Belamcandae rhizoma belamcandae, Largetrifoliolious Bugbane RhizmomeRhizoma Cimicifugae, Radix Sanguisorbae SanguisorbaofficinalisL, Eucommia ulmoides Oliver Eucommia ulmoides, Rhizoma Zingiberis RecensZingiber officinale Roscoe, Salvia chinensis Benth Salvia chinensis Benth, Folium Photiniae Photinia serrulata Lindl, Lignum Sappan Lignum Sappan, Semen Persicae Semen Persicae, Radix Asparagi Radix Asparagi, Root of Nakedcaule Groundsel Radix Semiaquilegiae, Root of Common carpesium Herba Carpesii Abrotanoidis, Semen lepidii Semen Lepidii, Herb of Tuberculate Speranskia Phryma leptostachya L. subsp. asiatica (Hara), China Dodder Semen Cuscutae, Semen Vaccariae Semen Vaccariae, Herb of Coffee Senna Cassia occidentalis Linn, Fructus Mume Fructus Mume, Root of Combined Spicebush Radix Linderae, Fig Ficus carica Linn, Medicinal Evodia Fruit Evodia rutaecarpa (Juss.) Benth, Chinese Gall, Chinese Nut-gall Rhus chinensis Mill, Sessileflower Acanthopanax Bark Cortex Acanthopanax Radicis, All-grass of Bluecalyx Japanese Rabdosia, Fructus Foeniculi Fructus Foeniculi, Common Cephalanoplos Herb Cirsium setosum (Willd.) MB, Flos Magnoliae Flos Magnoliae, Paniculate Swallowwort Root Cynanchum paniculatum (Bunge) Kitagawa, Linseed,seed of Flax Linseed seed of Flax, Fructus Alpiniae Oxyphyllae Alpinia oxyphylla Miq, Job's tears seed Semen Coicis, Herba Artemisiae Scopariae ArtemisiacapillarisThunb, Folium Ginkgo Ginkgobiloba, Heartleaf Houttuymia Herb Houttuynia cordata Thunb, Turmeric Root-tuber Radix Curcumae, Akebia Fruit Foreknowledge, Hiraute Shiny Bugleweek Herb Aconitum gymnandrum Maxim, Rhizoma Paridis RhizomaParidis, Polyporus Polyporus, Root of Sinkiang Arnebia Lithospermum erythrorhizon Sieb. et Zucc, Herba Violae Viola yedoensis Makino, Fluoritum Fluoritum Caulis Perillae Perilla frutescens （L.）Britton
- Conditions
- Metastatic Cancer
- Being tested
- Non Chemotherapy, Chemotherapy and target therapy, Chinese herb medicine
- Keywords
- ex vivo high-throughput drug screening assay
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non ChemotherapyDrug
Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.
Chemotherapy and target therapyDrug
Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.
Chinese herb medicineDrug
Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Alphacait-guided therapy | Experimental | Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines until the patient progresses, intolerant, the patient withdrawn or the investigator determines that the medication must be discontinued. Receives: Drug: Non Chemotherapy; Drug: Chemotherapy and target therapy; Drug: Chinese herb medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
Progression-free survival (PFS) is defined as the time from assignment in the trial to disease progression or death from any cause.
Measured: 36 months
Secondary outcomes (5)
Overall survival(OS)
Defined as the time from assignment to death from any cause.
Measured: 36 months
Overall response rate (ORR)
Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy
Measured: 36 months
Disease control rate(DCR)
Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response or stable disease to therapy
Measured: 36 months
Incidence of Treatment-Emergent Adverse Events
Drug-related adverse reactions must be recorded, mainly in the following：myelosuppression including neutropenia, anemia and thrombocytopenia;Cardiac toxicity; muscle fatigue, pain, imbalance; Oral ulcers: the patient's gums, cheeks, throat and tongue are prone to ulcers;nausea, vomiting, constipation or diarrhea;hair loss;skin discomfort;hormonal fluctuations, sexual dysfunction, infertility; damage of the kidney;anxiety and depression.
Measured: 36 months
Biomarkers
Expectations of exploratory markers for this study include the status of exploratory biomarkers associated with immunohistochemistry (IHC) or quantitative reverse transcription polymerase chain reaction (qRT-PCR), a new generation sequencing method (NGS), Nanostring technique and / or other methods to evaluate archived and/or newly acquired tumor tissue, as well as its association with disease status and/or (Including but not limited to somatic mutations and other exploratory markers) according to qRT-PCR and NGS techniques, and to evaluate the relationship between the therapeutic response, the status of the biomarker during exploratory treatment and during treatment, and the evaluation of plasma, serum or whole blood samples (including but not limited to somatic mutations and other exploratory markers) The association of the above markers with disease status and / or therapeutic response.
Measured: 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Jan 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This single center, open-label, single arm, non-randomized study is designed to evaluate safety, progression-free survival(PFS),overall survival (OS), objective response rate (OPR), and disease control rate (DCR) of chemotherapy or target therapy or chinese medicine based on the Alphacait screening system in subjects with advanced malignant tumor.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haining Health-Coming Biotech Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Alphacait, LLC
- Responsible party
- Sponsor
- Investigators
- Haizhou Lou, MD, Principal investigator, Sir Run Run Shaw HospitalLinghua Zhu, MD, Principal investigator, Sir Run Run Shaw HospitalEnguo Chen, MD, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299452
- Sponsor's protocol ID
- Alphacait 001
- Status last verified
- Feb 2019
- First submitted
- 28 Aug 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Through publication after study completion
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Studies by Using Alphacait to Screen Drug Combinations for Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT03299452
- Acronym / sponsor ID
- Alphacait 001
- Conditions
- Metastatic Cancer
- Keywords
- ex vivo high-throughput drug screening assay
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Haining Health-Coming Biotech Co., Ltd.University, hospital or other
- Collaborators
- Alphacait, LLC
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
Detailed description
Tumor heterogeneity leads to a significant difference in the rate of response to drugs in patients with the same pathological type. According to the information, the current initial effective rate of domestic and foreign chemotherapeutic single drug is no more than 30%, even if treated with repeated medication or replacement treatment program, the responsive rate is generally not more than 10%. This heterogeneity of tumor is the biological basis of precision medicine, and how to predict cancer drug sensitivity is a clinical need to solve the practical problems.
Traditional PDX (patient-derived engraft) technology utilizes patient's fresh tumor tissue (containing tumor cells, stromal cells and vascular components), and inoculates in immunodeficient mice to establish mouse tumor model. This method can better reflect the true biological characteristics of tumor, while the mouse tumor tissue can be continuously passed on, and greatly facilitate tumor biology research. According to the transplant site it can be divided into orthotopic transplantation and ectopic transplantation (mostly subcutaneous or renal transplantation). However, the traditional PDX model has its disadvantage of low success rate and time consuming. Most of the tumor matrix after transplantation can be replaced by the corresponding components in mice, leading to differences in the biological properties of the original tumor.
In view of this imperfection, we developed an optimized drug selection model based on the Alphacait screening system that combines artificial intelligence, synthetic lethal and combinational chemistry, which allows rapid selection of candidates from millions of drug combinations. We want to provide physicians with individualized drug therapy through a new in vitro and in vivo drug-sensitive screening technique, to achieve rapid and accurate selection of cancer clinical treatment.
In order to achieve the two key requirements of tumor tissue culture system in vitro, the establishment of tumor microenvironment we introduced the millimeter-sized microbeads, based on combinatorial chemistry in the culture medium. The surface of the microbeads is coated with small molecules that can specifically absorb high levels of metabolites secreted by the tumor cells into the matrix, thereby mimicking in vivo circumstances. In short, we innovatively applied microbeads technology to solve the inherent limitations of 3D organoid culture - no blood circulation in vitro.
Purpose and design Primary endpoint: progression-free survival (PFS) Secondary endpoints: overall survival (OS); disease control rate (DCR), objective response rate (ORR); safety; blood test and gene test in the aspect of biomarkers. Expectations of exploratory markers for this study include the status of exploratory biomarkers associated with immunohistochemistry (IHC) or quantitative reverse transcription polymerase chain reaction (qRT-PCR), a new generation sequencing method (NGS), Nanostring technique and / or other methods to evaluate archived and/or newly acquired tumor tissue, as well as its association with disease status and/or (Including but not limited to somatic mutations and other exploratory markers) according to qRT-PCR and NGS techniques, and to evaluate the relationship between the therapeutic response, the status of the biomarker during exploratory treatment and during treatment, and the evaluation of plasma, serum or whole blood samples (including but not limited to somatic mutations and other exploratory markers) The association of the above markers with disease status and / or therapeutic response.
Research design This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on the Alphacait screening system in subjects with advanced malignant tumor.
List of drugs used by the Alphacait screening system is as follow:
Non chemotherapy drug
Albendazole Tablets, Alfacalcidol Soft Capsules, Aripiprazole Tablets, Anastrozole Tablets, Azithromycin, Acyclovir Dispersible Tablets, Aztreonam, OLanzapine Tablets, Omeprazole Enteric-coated Capsules, Ornidazole and Sodium Chloride Injection, resveratrol, citicoline sodium injection, Bevacizumab，Avastin, Phenobarbital, Amlodipine Besylate Tablets, phenytoin sodium tablet, Piroxicam tablets, Allopurinol tablets, Propylthiouracil Tablets, Sodium Valproate for Injection, Nuprin Tablets, Goserelin Acetate Sustained-Release Depot, Zoladex, Megestrol Acetate Dispersible Tablets, Prednisone Acetate Tablets, Desmopressin Acetate Injection, Low-molecular-weight Heparin Sodium Injection, Digoxin Tablets, Dexamethasone Sodium phosphate Injection, Bacillus Licheniformis Capsule, tabellae paracetamol, Levodopa and Benserazide Hydrochloride Tablets, Domperidone Tablets, Metformin, Famotidine tablets, Fenbendazole, Nitrofurantoin Enteric-coated Tablets, Fluconazole and Sodium Chloride Injection, Haloperidol Injection, Flupentixol and Melitracen Tablets, Compound Zedoary Turmeric Oil Suppositories, Compound Sulfamethoxazole Injection, Compound Hypotensive Tablets, Bisoprolol Fumarate Tablets, Quetiapine Fumarate Tablets, Injection Mannitou, Heparin sodium, Bismuth Potassium Citrate Tablets, Banan tablet, Erythromycin enteric capsules, Metoprolol succinate sustained-release tablets, Warevan tablet, Huaier granule, Cyclosporine, Progesterone injection, Gabapentin capsules, Mebendazole Chewable Tablets, Apatinib Mesylate, Phentolamine Mesylate Injection, Imatinib Mesylate, Neostigmine Methylsulfate Injection, Imatinib Mesylate Tablets, Thiamazole Tablets, Metronidazole, Colloidal Bismuth Pectin Capsules, Metoprolol Tartrate Tablets, Carbamazepine Tablets, Captopril Tablets, Clarithromycin Sustained-release Tablets, Clindamycin Phosphate Injection, Lamictal, Letrozole Tablets, Lara chips, Tripterygium Glycosides, Atorvastatin, Ribavirin injection, Rifampicin Capsules, Risperidone Tablets, Primaquine Diphosphate, Chloroquine Phosphate Tablets, Amikacin Sulfate Injection, Atropine sulphate injection, Magnesium sulfate injection, Azathioprine Tablets, Sulfasalazine Enteric-coated Tablets, Roxithromycin Soft Capsules, Clozapine Tablets, Desloratadine Tablets, Flupirtine Maleate, Fluvoxamine Maleate Tablets, Chlorphenamine Maleate Tablets, Enalapril Maleate Tablets, Meloxicam, Mesalazine Enteric-coated Tablets, Mirtazapine, Naproxen Tablets, Nikethamide Injection, Nimodipine Injection, Nitrendipine Tablets, Norfloxacin Capsules, Hydroxycarbamide Tablets, Artemisinin, Benzylpenicillin sodium, Hydrocortisone Injection, Citalopram Hydrobromide Tablets, Gentamicin, Colchicine Tablets, Doxifluridine Capsules, Deslanoside Injection, Ciprofloxacin Lactate and Sodium Chloride Injection, Celecoxib Capsules, Trifluoperazine, Tetrastigma hemsleyanum Diels et Gilg, Thalidomide Tablets, Sulpiride Tablets, Diclofenac Potassium Capsules, Clostridium butyricum TO-A, Dihydroartemisinin and Piperaquine Phosphate Tablets, Tetracycline Tablets, Lithium Carbonate Sustained-release Tablets, Tegafur Injection, Teicoplanin, Tinidazole and Sodium Chloride Injection, Cefoxitin, Ceftizoxime Sodium, Topiramate Tablets, Vancomycin, Tretinoin Tablets, Vemurafenib, Vitamin A, Vitamin B2 Tablets, Vitamin D2 Injection, Cimetidine Tablets, Cimetidine Injection, Nifedipine Sustained Release Tablets, Nitroglycerin Injection, Isosorbide Dinitrate Injection, Valsartan Dispersible Tablets, Simvastatin Tablets, Thymalfasin, Ursodeoxycholic Acid, Folic acid calcium salt hydrate, Amitriptyline Hydrochloride Tablets, Bupropion Hydrochloride Sustained-Release Tablets, Amiodarone Hydrochloride Tablets, Ondansetron Hydrochloride Injection, Betahistine Hydrochloride Injection, Diphenhydramine Hydrochloride Injection, Bupropion Hydrochloride Injection Tablets, 3-Hydroxytyramine hydrochloride, Doxepin Hydrochloride, Flunayizine Hydrochloride Capsules, Prozac, Metoclopramide Dihydrochloride Injection, Arginine Hydrochloride Injection, Clindamycin Hydrochloride Injection, Raloxifene Hydrochloride Tablets, Ranitidine Hydrochloride Capsules, Lidocaine Hydrochloride Injection, Lobeline Hydrochloride Injection,, Chlorpromazine, Clomipramine Hydrochloride Tablets, Omeprazole Magnesium Enteric-coated Tablets, Mexiletine Hydrochloride Tablets, Paroxetine Hydrochloride Tablets, Procaine Hydrochloride for Injection, Trazodone Hydrochloride Tablets, Daunorubicin hydrochloride, Cyproheptadine Hydrochloride Tablets, Sertraline Hydrochloride Tablets, Tamsulosin Hydrochloride Sustained Release Capsules, Terazosin Hydrochloride Tablets, Verapamil Hydrochloride Tablets, Venlafaxine Hydrochloride Capsules, Raceanisodamine Hydrochloride Injection, Berberine Hydrochloride Tablets, Ethambutol Hydrochloride Tablets, Levofloxacin Hydrochloride for Injection, Itraconazole, Ivermectin, IPTG；Isopropyl-β-D-thiogalactoside, Isopropyl-beta-D-thiogalactopyranoside, Isoniazid Tablets, Indapamide Tablets, Indomethacin Enteric-coated Tablets, Amoxicillin Sodium and Clavulanate Potassium for injection, Azithromycin for Injection, Acyclovir for Injection, Ampicillin Sodium Injection, Omeprazole Sodium for Injection, Oxacillin Sodium for Injection, Biapenem for Injection, Benzathine Penicillin For Injection, Sodium Valproate for Injection, Ganciclovir, Fosfomycin Sodium for Injection, Asparaginase, Urokinase for Injection, Piperacillin Sodium for Injection, Artesunate for Injection, Sodium Nitroprusside, Diltiazem Hydrochloride for Injection, Recombinant Human Interferon gamma for Injection, Levobupivacaine, Levothyroxine Sodium Tablets, Levofloxacin Tablets
Chemotherapy and target therapy drugs
Aidi injection, Oxaliplatin for Injection, Epirubicin, Dacarbazine, Dabrafenib, mesylate, Dabratinib, Dasatinib Tablets, Sorafenib Tosylate Tablets, Doxorubicin, Docetaxel, 5-Fluorouracil, Juyuansuan Tamoxifen, Cino bufotalin, Cyclophosphamide, Gefitinib (pure) powder, Gemcitabine hydrochloride, Methotrexate, Carboplatin, Capecitabine, Kanglaite Injection, Raltitrexed, Mabthera, Lobaplatin for Injection, Mitoxantrone, Nedaplatin, Mercaptopurine, Cisplatin, Mitomycin for Injection, Tacrolimus, Tegafur, Gimeracil and Oteracil Potassium, Temozolomide, Cetuximab Solution for Infusion, Lobaplatin for Injection, Mitoxantrone, Nedaplatin, Mercaptopurine, Cisplatin, Mitomycin for Injection, Tacrolimus, Tegafur, Gimeracil and Oteracil Potassium, Temozolomide, Cetuximab Solution for Infusion
Chinese Herb Medicine
English Name Latin Name Job's tears seed Coicis Semen, Japanese Ardisia Herb Japanese Ardisia Herb, White Hyacinth Bean Semen Dolichoris Album, Spreading Hedyotis Herb Hedyotis diffusa, Willowleaf Swallowwort Rhizome Rhizoma Cynanchi Stauntonii, Large head Atractylodes Rh Rhizoma Atractylodis Macrocephalae, Sessile Stemona Root Japanese Stemona Root, Lily Lilium brownii var. viridulum, Seman Platycladi Seman, Isatis root Isatis tinctoria, Herba Lobeliae Chinensis Lobelia chinensis Lour, Pinellia ternata Pinellia ternata (Thunb.) Breit, Scutellaria barbata Scutellaria barbata, CoasiaI GIehnia Root Glehnia littoralis, Fritillary fritillary, Ficus pumila Linn Ficus pumila, Seed-coat of Hyacinth Dolichos, Areca Seed, Betel Nut Semen Arecae, Malaytea Scurfpea Fruit Fructus Psoraleae, Semen raphani , Silkworm shit Faeces Bombycis, Siberian Cocklour Fruit Fructus Xanthii, Rhizome of Swordlike Atractylodes Rhizoma Atractylodis, Root of Chinese Thorowax Radix Bupleuri, Radices paeoniae rubra Paeoniae Rubra Radix, Dan - shen Root Salviae Miltiorrhizae Radix, Tree Peony Root - bark Moutan Radicis Cortex, Chinese Goldthread Rhizome Coptidis Rhizoma, Skunk Bugbane Rhizome Cimicifugae Foetidae Rhizoma, Coix seed Semen Coicis Szechwan Chinaberry Fruit Fructus Meliae Toosendan, Radix Cyathulate Radix Cyathulae, Common Andrographis Herb Herba Andrographis, Radix et Caulis Acanthopanacis Senticosi Radix et Caulis Acanthopanacis Senticosi, Japanese Thistle Herbor Root Herba seu Radix Cirsii Japonici, Indigowoad Leaf, Leaf of Indigowoad Folium Isatidis, Danshen Root, Root of Dan-shen Salviae Miltiorrhizae Radix et Rhizoma, Root of Pilose Asiabell Radix Codonopsis, Fructus Oryzae Germinatus Fructus Oryzae Germinatus, Humifuse Euphorbia Herb Herba Euphorbiae Humifusae, Chinese Waxgourd Peel Exocarpium Benincasae, Waxgourd seed Semen Benincasae, Rabdosia rubesens,hamst Rabdosia rubescens, Rhioxma Curcumae Aeruginosae Rhizoma Curcumae, Divaricate Saposhnikovia RootRadix Saposhnikoviae, Indian Buead Poria, Pine among the Indian Bread, Blighted Wheat Fructus Tritici Levis, Radix Glycyrrhizae Radix Glycyrrhizae, Toad skin, Perfoliate Knotweed Herb Polygonum perfoliatum, Ligusticum sinense Oliv Rhizoma Ligustici, Barbary Wolfberry Fruit Fructus Lycii, Herba Pogostemonis Herba Pogostemonis, Sargassum Sargassum, Yerbadetajo Herb Herba Ecliptae Eclipta prostrala, Terminalia chebula Retz, Taxus chinensis Taxus chinensis (Pilger) Rehd, Flos Carthami Flos Carthami, Root of Kirilow Rhodiola Herba Rhodiolae, Figwortflower Picrorhiza Rhizome Rhizoma Picrorhizae, Polygonum cuspidatum Rhizoma Polygoni Cuspidati, Pricklyash Peel Pericarpium Zanthoxyli, Talcum Talcum, Exocarpium Citri Grandis Exocarpium Citri Grandis, Phellodendron Chinese Schneid Cortex Phellodendri, Manyflower Solomonseal Rhizome Rhizoma Polygonati, Radix Astragali Radix Astragali seu Hedysari, Radix Scutellariae, Flos Celosiae Cristae Flos Celosiae Cristatae, Suberect Spatholobus Stem Caulis Spatholobi, Rhizoma Curcumae Longae Rhizoma Curcumae Longae, Christina Loosestrife HerbHerba Lysimachiae, Japanese Honysuckle Flower Bud Flos Lonicerae, Cherokee Rose Fruit Fructus Rosae Laevigatae, Chrysanthemum flower Flos Chrysanthemi, Spikemoss Herba Selaginellae, Cassia seed Semen Cassiae, Lightyellow sophora root Radix Sophorae Flavescentis, Kelp Laminariae Thallus, Semen Litchi Semen Litchi, Chinese trumpet creeper Campsis grandiflora, Diverse Wormwood Herb Herba Artemisiae Anomalae, Radix Gentianae Gentiana Scabra Bunge, Reed Rhizome Stemmacanthae Unifori Radix, Caulis Trachelospermi Trachelospermi Jasminoidis Caulis, Lv Bean Spermodermis Phaseoli Radiati, European Verbena Herb Herba Verbenae Officinalis, Herba Portulacae Portulaca oleracea L, Radix Ophiopogonis Ophiopogonis Radix, Fructus Hordei Germinatus Hordei Germinatus Fructus, Concha Ostreae Concha Ostreae, Costustoot, Common Vladimiria Root Aucklandiae Radix, Fructus Ligustri Lucidi Ligustri Lucidi Fructus, Fortune Eupatorium Herb Eupatorii Fortunei Herba, Folium Eriobotryae Eriobotryae Japonicae Folium, Dandelion Herba Taraxaci, Flower of Shepherdspurse Capsella bursa-pastoris (L.)Medic), Rhizoma Homalomenae Rhizoma Homalomenae, Gordon Enryale Seed Euryales Semen, Radix Gentinae Gentianae Macrophyllae Radix, Cortex Fraxini Fraxini Cortex, Caulis SinomeniiI Caulis Sinomenii, Semen Celosiae Celosiae Argenteae Semen, Herba Dianthi Dianthi Superbi Herba, Caulis Lonicerae Lonicerae Caulis, Cortex CinnamoniCinnamomi Cassiae Cortex, Rhizoma Srarganii Rhizoma Sparganii, Sanchi Panax pseudo-ginseng var, Radix tetrastigme Tetrastigma hemsleyanum Diels et Gilg, Folium Mori Mori Folium, Chinese yam Dioscorea opposite, Amorphophallus rivieri Durieu Amorphophallus rivieri Durieu, Snake venom, Snake Slough Serpentis Periostracum, Rhizoma Belamcandae rhizoma belamcandae, Largetrifoliolious Bugbane RhizmomeRhizoma Cimicifugae, Radix Sanguisorbae SanguisorbaofficinalisL, Eucommia ulmoides Oliver Eucommia ulmoides, Rhizoma Zingiberis RecensZingiber officinale Roscoe, Salvia chinensis Benth Salvia chinensis Benth, Folium Photiniae Photinia serrulata Lindl, Lignum Sappan Lignum Sappan, Semen Persicae Semen Persicae, Radix Asparagi Radix Asparagi, Root of Nakedcaule Groundsel Radix Semiaquilegiae, Root of Common carpesium Herba Carpesii Abrotanoidis, Semen lepidii Semen Lepidii, Herb of Tuberculate Speranskia Phryma leptostachya L. subsp. asiatica (Hara), China Dodder Semen Cuscutae, Semen Vaccariae Semen Vaccariae, Herb of Coffee Senna Cassia occidentalis Linn, Fructus Mume Fructus Mume, Root of Combined Spicebush Radix Linderae, Fig Ficus carica Linn, Medicinal Evodia Fruit Evodia rutaecarpa (Juss.) Benth, Chinese Gall, Chinese Nut-gall Rhus chinensis Mill, Sessileflower Acanthopanax Bark Cortex Acanthopanax Radicis, All-grass of Bluecalyx Japanese Rabdosia, Fructus Foeniculi Fructus Foeniculi, Common Cephalanoplos Herb Cirsium setosum (Willd.) MB, Flos Magnoliae Flos Magnoliae, Paniculate Swallowwort Root Cynanchum paniculatum (Bunge) Kitagawa, Linseed,seed of Flax Linseed seed of Flax, Fructus Alpiniae Oxyphyllae Alpinia oxyphylla Miq, Job's tears seed Semen Coicis, Herba Artemisiae Scopariae ArtemisiacapillarisThunb, Folium Ginkgo Ginkgobiloba, Heartleaf Houttuymia Herb Houttuynia cordata Thunb, Turmeric Root-tuber Radix Curcumae, Akebia Fruit Foreknowledge, Hiraute Shiny Bugleweek Herb Aconitum gymnandrum Maxim, Rhizoma Paridis RhizomaParidis, Polyporus Polyporus, Root of Sinkiang Arnebia Lithospermum erythrorhizon Sieb. et Zucc, Herba Violae Viola yedoensis Makino, Fluoritum Fluoritum Caulis Perillae Perilla frutescens （L.）Britton
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single center, open-label, single arm, non-randomized study is designed to evaluate safety, progression-free survival(PFS),overall survival (OS), objective response rate (OPR), and disease control rate (DCR) of chemotherapy or target therapy or chinese medicine based on the Alphacait screening system in subjects with advanced malignant tumor.
| Arm | Type | Receives |
|---|---|---|
| Alphacait-guided therapy | Experimental | Drug: Non Chemotherapy, Drug: Chemotherapy and target therapy, Drug: Chinese herb medicineDrugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines until the patient progresses, intolerant, the patient withdrawn or the investigator determines that the medication must be discontinued. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Advanced recurrent or metastatic malignant tumor confirmed by pathological diagnosis;
- At least one measurable malignant lesion;
- Failed previous standard treatment or with tumor recurrence, and no standard therapeutic regimen available;
- No radiation therapy within last four weeks or recovered from last radiation related acute complication, if applicable; prophylactic brain radiation therapy or palliative radiation treatment for bone metastasis is acceptable;
- No gender requirement and must be no younger than18 years old;
Key exclusion criteria (14 listed)
- Symptomatic brain metastasis (could still enroll into the study if treatment finished 21 days prior to the enrollment and the patient is stable, but brain MRI, CT or angiogram is needed to rule out no intracranial hemorrhage)
- Following cardiac disease: second-degree or above cardiac ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval male>450 ms, female>470ms), according to NYHA criteria, III to IV cardiac insufficiency, or echocardiogram reveals left ventricular ejection fraction (LVEF) <50%;
- History of pulmonary interstitial lung disease or active interstitial lung disease;
- Coagulation dysfunction (INR >1.5 or PT>ULN+ 4sec, or PTT>1.5 ULN), with bleeding tendency or currently receiving thrombolysis therapy or anticoagulation treatment;
- Clinical bleeding episode or bleeding tendency within past three months, such as GI bleeding, hemorrhagic gastric ulcer, stool guaiac++ positive, or with vasculitis；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non ChemotherapyDrugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines. | Drug | Alphacait-guided therapy |
| Chemotherapy and target therapyDrugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines. | Drug | Alphacait-guided therapy |
| Chinese herb medicineDrugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines. | Drug | Alphacait-guided therapy |
Primary outcome
Progression-free survival(PFS)
Time frame: 36 months
Progression-free survival (PFS) is defined as the time from assignment in the trial to disease progression or death from any cause.
5 secondary outcomes
Overall survival(OS)
Time frame: 36 months
Overall response rate (ORR)
Time frame: 36 months
Disease control rate(DCR)
Time frame: 36 months
Incidence of Treatment-Emergent Adverse Events
Time frame: 36 months
Biomarkers
Time frame: 36months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Yes. Through publication after study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haizhou Lou, MD principal investigator
Sir Run Run Shaw Hospital
Linghua Zhu, MD principal investigator
Sir Run Run Shaw Hospital
Enguo Chen, MD principal investigator
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Non Chemotherapy, Chemotherapy and target therapy and Chinese herb medicine in people with Metastatic Cancer, run by Haining Health-Coming Biotech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Li, MD (86-137-50766911, yanfangren1019@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.