Sarcoma, Soft TissuePhase 2ALTER-S005NCT03815474
Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Soft Tissue Sarcoma Patients
A Phase 2 study testing anlotinib in people with Sarcoma, Soft Tissue, run by Liaoning Cancer Hospital & Institute at 1 site in China.
Trial summary
Anlotinib is a multi-target receptor tyrosine kinase inhibitor. It can inhibit the angiogenesis related kinase, such as Vascular Endothelial Growth Factor Receptor (VEGFR), Fibroblast Growth Factor Receptor(FGFR), Platelet-Derived Growth Factor Receptor(PDGFR), and tumor cell proliferation related kinase c-Kit kinase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue
- What is being tested?
- anlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2019to 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
- Signed the informed consent form prior to patient entry;
- ≥ 18 years of age , regardless of gender；ECOG :0-1;Expected Survival Time: Over 3 months;
- Histologically confirmed diagnosis of un-resectable or recurrent metastatic soft tissue sarcoma, such as: leiomyosarcoma, synovial sarcoma, undifferentiated pleomorphic sarcoma, liposarcoma , angiosarcoma and other sarcomas. The following histologies are excluded: alveolar Soft tissue sarcoma, rhabdomyosarcoma, chondrosarcoma, osteosarcoma, gastrointestinal stromal tumor, humeral cutaneous fibrosarcoma, Ewing sarcoma/primary neuroectodermal tumor, inflammatory myofibroblastic sarcoma and malignant mesothelioma.
- Patients who were not treated with anthracyclines or other tyrosinase inhibitors or angiostatins within the first 6 months should be enrolled.
- Evaluable disease by imaging or physical exam or measurable disease defined as at least one lesion that can be accurately measured according to RECIST version 1.1.
- normal main organs function as defined below: Hemoglobin (Hb) ≥ 80g / L, Neutrophils (ANC) ≥ 1.5 × 109 / L, Platelet count (PLT) ≥ 80 × 109 / L, Serum creatinine (Cr) ≤ 1.5 × normal upper limit (ULN) or creatinine clearance (CCr) ≥ 60ml / min, Blood urea nitrogen (BUN) ≤ 2.5 × normal upper limit (ULN); Total bilirubin (TB) ≤ 1.5 × ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; If accompanied by liver metastases, ALT and AST ≤ 5 × ULN Albumin (ALB) ≥ 25 g/L. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%)
- Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped.
Who cannot join
- Prior treatment with any VEGFR tyrosine kinase inhibitor(such as sunitinib, sorafenib, bevacizumab, imatinib, famitinib, apatinib, regorafenib and other drugs).
- Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy, is planned for the first 4 weeks prior to enrollment or during the study. Radiation radiotherapy (EF-RT) was performed within 4 weeks prior to enrollment.
- A history of other malignancy ≤ 3 years previous
- Known brain metastases.
- The investigator judged that during the follow-up study, the tumor is very likely to invade the important blood vessels and cause fatal hemorrhage, or the formation of tumor thrombosis with large veins (iliac vessels, inferior vena cava, pulmonary veins, superior vena cava);
- The investigator judged that the presence of distinct pulmonary cavitary or necrotic tumors;
Show all 21Show fewer
- Serosal effusion with clinical symptoms requiring surgical management (including hydrothorax and ascites pericardial effusion)
- with any severe and/or uncontrolled disease, including:1)Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite optimal drug treatment).2)Arrhythmias with grade II and above myocardial ischemia or myocardial infarction, poor control (including corrected QT interval(QTc) men ≥ 450 ms, women ≥ 470 ms) and ≥ 2 congestive heart failure (New York Heart Association ( NYHA) rating).3)Poor control of diabetes (fasting blood glucose > 10mmol / L).4)Active or uncontrolled serious infection (≥ Common Terminology Criteria for Adverse Event(CTC AE) grade 2 infection);5)Patients with active hepatitis B or hepatitis C (hepatitis B: HBsAg-positive and hepatitis B virus(HBV) DNA ≥ 500 IU/mL; hepatitis C: hepatitis C virus(HCV) RNA-positive and abnormal liver function), or active infection requiring antimicrobial treatment (eg Treated with antibacterial drugs, antiviral drugs, antifungal drugs);6)renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g;7)Patients with seizures and need treatment
- Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or activated partial thromboplastin time(APTT) > 1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy.
- Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin.
- significant coughing blood in the 2 months before enrollment, or daily hemoptysis of 2.5ml or more.
- history of psychotropic substance abuse who are unable to quit or have a mental disorder.
- Tendencies of hereditary or acquired hemorrhagic and thrombotic (such as hemophilia patients, coagulopathy, thrombocytopenia, hypersplenism, etc.)
- Any major unhealed wound, ulcer, or fracture occurred in a patient who had undergone major surgery or trauma within 4 weeks and/or had any bleeding or bleeding episodes which the degree is bigger than CTCAE 3 grade within 4 weeks prior to enrollment.
- Active period digestive ulcers.
- Cavity sinus or perforation occurred within 6 months.
- Participated in other anti-tumor clinical trials within 4 weeks.
- Received a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole, erythromycin, and clarithromycin) within 7 days, or received a potent CYP3A4 inducer within 12 days prior to the study (eg. catarrh Treatment with imipramine, rifampicin and phenobarbital).
- Allergic reactions, hypersensitivity reactions or intolerance to anlotinib hydrochloride or its excipients.
- Pregnancy or lactation.
- The investigator believes that there are any conditions that may damage the subject or result in the subject not being able to meet or perform the research request.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liaoning Province Tumor Hospital
Shenyang, Liaoning, 110042
Li Shenglong, master
About this study
Official title: Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Locally Recurrent or Metastatic Soft Tissue Sarcoma Patients: a One-arm, Multi-center, Prospective Clinical Trial
Anlotinib is a multi-target receptor tyrosine kinase inhibitor. It can inhibit the angiogenesis related kinase, such as Vascular Endothelial Growth Factor Receptor (VEGFR), Fibroblast Growth Factor Receptor(FGFR), Platelet-Derived Growth Factor Receptor(PDGFR), and tumor cell proliferation related kinase c-Kit kinase. Anlotinib is an efficient second line therapeutic agent in treatment for metastatic soft tissue sarcoma which has been approved in clinical trials (ALTER-0203).Therefore , this study evaluates the safety and efficacy of anlotinib plus epirubicin and ifosfamide treat the metastatic or advanced soft tissue sarcoma .
Read the detailed description
This study is planned to be carried out in Liaoning, Jilin and Harbin provinces regional multi-center. 47 cases are preliminarily expected to be included. The study started in January 2019 and ended in December 2019. It is expected that the trial will end in December 2020. This study is a phase 2 study evaluating the safety and efficacy anlotinib and plus epirubicin and ifosfamide treat the metastatic or advanced soft tissue sarcoma .
All those participants need to sign informed consent forms for data collection and use for research purpose before inclusion .Those participants who were not treated with anthracyclines or other tyrosinase inhibitors or angiostatins within the first 6 months should be enrolled.
47 subjects with metastatic or advanced soft tissue sarcoma will receive epirubicin at 30mg/m2/day（day1-2 IV）, ifosfamide at 1.8g/m2/day (day1-5 IV) anlotinib at a dose of 12 mg once daily (day8-21 PO). After 6 treatment cycles,those participants will receive anlotinib at a dose of 12 mg once daily (day8-21 PO) in 21-day cycles until disease progression (defined by RECIST version 1.1) ot unacceptable toxicity.
- Conditions
- Sarcoma, Soft Tissue
- Being tested
- anlotinib
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anlotinibDrug
Also called epirubicin ifosfamide
Anlotinib 12 mg once daily for 14 days tablet by mouth ; epirubicin 30mg/m2 intravenous injection from 1 day to 2 , ifosfamide 1.8g/m2 intravenous injection from 1day to 5day with 6 cycles. Anlotinib 12 mg once daily for 14 days tablet by mouth to progressive disease
| Study group | Role | What they receive |
|---|---|---|
| anlotinib & epirubicin& ifosfamide | Experimental | interventions:Anlotinib 12 mg once daily for 14 days tablet by mouth ; epirubicin 30mg/m2 intravenous injection from 1 day to 2 , ifosfamide 1.8g/m2 intravenous injection from 1day to 5day with 6 cycles. Anlotinib 12 mg once daily for 14 days tablet by mouth to progressive disease Receives: Drug: anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival
Progress free survival (PFS) defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
Measured: Until Progressive Disease(PD) or death(up to 24 months)
Secondary outcomes (4)
Overall Survival
Overall Survival (OS) is defined as the time until death due to any cause.
Measured: From randomization until death (up to 24 months)
Objective Response Rate
Objective Response Rate (ORR) is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
Measured: Each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Measured: Each 42 days up to intolerance the toxicity or PD (up to 24 months)
Safety(Number of Participants with Adverse Events and Clinical laboratory numerical evaluation as a Measure of Safety)
Number of Participants with Adverse Events and Clinical laboratory numerical evaluation as a Measure of Safety.
Measured: Each 42 days up to intolerance the toxicity or PD (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start20 May 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sarcoma, Soft TissueStudies 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
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaoning Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University, Dalian Municipal Central Hospital, The Second Affiliated Hospital of Dalian Medical University, China-Japan Friendship Hospital, The Third Affiliated Hospital of Harbin Medical University, Second Hospital of Jilin University, Daqing Oil Field Hospital
- Responsible party
- Sponsor
- Investigators
- Li Shenglong, master, Principal investigator, Project sponsor of Liaoning Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815474
- Sponsor's protocol ID
- KY2018012
- Acronym
- ALTER-S005
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chawla SP, Papai Z, Mukhametshina G, Sankhala K, Vasylyev L, Fedenko A, Khamly K, Ganjoo K, Nagarkar R, Wieland S, Levitt DJ. First-Line Aldoxorubicin vs Doxorubicin in Metastatic or Locally Advanced Unresectable Soft-Tissue Sarcoma: A Phase 2b Randomized Clinical Trial. JAMA Oncol. 2015 Dec;1(9):1272-80. doi: 10.1001/jamaoncol.2015.3101.
PubMed 26378637Spannuth WA, Sood AK, Coleman RL. Angiogenesis as a strategic target for ovarian cancer therapy. Nat Clin Pract Oncol. 2008 Apr;5(4):194-204. doi: 10.1038/ncponc1051. Epub 2008 Feb 12.
PubMed 18268546
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Locally Recurrent or Metastatic Soft Tissue Sarcoma Patients: a One-arm, Multi-center, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT03815474
- Acronym / sponsor ID
- ALTER-S005 / KY2018012
- Conditions
- Sarcoma, Soft Tissue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Liaoning Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University, Dalian Municipal Central Hospital, The Second Affiliated Hospital of Dalian Medical University, China-Japan Friendship Hospital, The Third Affiliated Hospital of Harbin Medical University, Second Hospital of Jilin University, Daqing Oil Field Hospital
- Study start
- 20 May 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 Jan 2019 (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.
Anlotinib is a multi-target receptor tyrosine kinase inhibitor. It can inhibit the angiogenesis related kinase, such as Vascular Endothelial Growth Factor Receptor (VEGFR), Fibroblast Growth Factor Receptor(FGFR), Platelet-Derived Growth Factor Receptor(PDGFR), and tumor cell proliferation related kinase c-Kit kinase. Anlotinib is an efficient second line therapeutic agent in treatment for metastatic soft tissue sarcoma which has been approved in clinical trials (ALTER-0203).Therefore , this study evaluates the safety and efficacy of anlotinib plus epirubicin and ifosfamide treat the metastatic or advanced soft tissue sarcoma .
Detailed description
This study is planned to be carried out in Liaoning, Jilin and Harbin provinces regional multi-center. 47 cases are preliminarily expected to be included. The study started in January 2019 and ended in December 2019. It is expected that the trial will end in December 2020. This study is a phase 2 study evaluating the safety and efficacy anlotinib and plus epirubicin and ifosfamide treat the metastatic or advanced soft tissue sarcoma .
All those participants need to sign informed consent forms for data collection and use for research purpose before inclusion .Those participants who were not treated with anthracyclines or other tyrosinase inhibitors or angiostatins within the first 6 months should be enrolled.
47 subjects with metastatic or advanced soft tissue sarcoma will receive epirubicin at 30mg/m2/day（day1-2 IV）, ifosfamide at 1.8g/m2/day (day1-5 IV) anlotinib at a dose of 12 mg once daily (day8-21 PO). After 6 treatment cycles,those participants will receive anlotinib at a dose of 12 mg once daily (day8-21 PO) in 21-day cycles until disease progression (defined by RECIST version 1.1) ot unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anlotinib & epirubicin& ifosfamide | Experimental | Drug: anlotinibinterventions:Anlotinib 12 mg once daily for 14 days tablet by mouth ; epirubicin 30mg/m2 intravenous injection from 1 day to 2 , ifosfamide 1.8g/m2 intravenous injection from 1day to 5day with 6 cycles. Anlotinib 12 mg once daily for 14 days tablet by mouth to progressive disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed the informed consent form prior to patient entry;
- ≥ 18 years of age , regardless of gender；ECOG :0-1;Expected Survival Time: Over 3 months;
- Histologically confirmed diagnosis of un-resectable or recurrent metastatic soft tissue sarcoma, such as: leiomyosarcoma, synovial sarcoma, undifferentiated pleomorphic sarcoma, liposarcoma , angiosarcoma and other sarcomas. The following histologies are excluded: alveolar Soft tissue sarcoma, rhabdomyosarcoma, chondrosarcoma, osteosarcoma, gastrointestinal stromal tumor, humeral cutaneous fibrosarcoma, Ewing sarcoma/primary neuroectodermal tumor, inflammatory myofibroblastic sarcoma and malignant mesothelioma.
- Patients who were not treated with anthracyclines or other tyrosinase inhibitors or angiostatins within the first 6 months should be enrolled.
- Evaluable disease by imaging or physical exam or measurable disease defined as at least one lesion that can be accurately measured according to RECIST version 1.1.
Key exclusion criteria (21 listed)
- Prior treatment with any VEGFR tyrosine kinase inhibitor(such as sunitinib, sorafenib, bevacizumab, imatinib, famitinib, apatinib, regorafenib and other drugs).
- Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy, is planned for the first 4 weeks prior to enrollment or during the study. Radiation radiotherapy (EF-RT) was performed within 4 weeks prior to enrollment.
- A history of other malignancy ≤ 3 years previous
- Known brain metastases.
- The investigator judged that during the follow-up study, the tumor is very likely to invade the important blood vessels and cause fatal hemorrhage, or the formation of tumor thrombosis with large veins (iliac vessels, inferior vena cava, pulmonary veins, superior vena cava);
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 |
|---|---|---|
| anlotinibAlso: epirubicin ifosfamideAnlotinib 12 mg once daily for 14 days tablet by mouth ; epirubicin 30mg/m2 intravenous injection from 1 day to 2 , ifosfamide 1.8g/m2 intravenous injection from 1day to 5day with 6 cycles. Anlotinib 12 mg once daily for 14 days tablet by mouth to progressive disease | Drug | anlotinib & epirubicin& ifosfamide |
Primary outcome
Progress free survival
Time frame: Until Progressive Disease(PD) or death(up to 24 months)
Progress free survival (PFS) defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
4 secondary outcomes
Overall Survival
Time frame: From randomization until death (up to 24 months)
Objective Response Rate
Time frame: Each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate
Time frame: Each 42 days up to intolerance the toxicity or PD (up to 24 months)
Safety(Number of Participants with Adverse Events and Clinical laboratory numerical evaluation as a Measure of Safety)
Time frame: Each 42 days up to intolerance the toxicity or PD (up to 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Results publication: PubMed 26378637Chawla SP, Papai Z, Mukhametshina G, Sankhala K, Vasylyev L, Fedenko A, Khamly K, Ganjoo K, Nagarkar R, Wieland S, Levitt DJ. First-Line Aldoxorubicin vs Doxorubicin in Metastatic or Locally Advanced Unresectable Soft-Tissue Sarcoma: A Phase 2b Randomized Clinical Trial. JAMA Oncol. 2015 Dec;1(9):1272-80. doi: 10.1001/jamaoncol.2015.3101.
- Results publication: PubMed 18268546Spannuth WA, Sood AK, Coleman RL. Angiogenesis as a strategic target for ovarian cancer therapy. Nat Clin Pract Oncol. 2008 Apr;5(4):194-204. doi: 10.1038/ncponc1051. Epub 2008 Feb 12.
- Individual participant dataSharing planned: No
Related trials for Sarcoma, Soft Tissue
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
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.
Li Shenglong, master principal investigator
Project sponsor of Liaoning Province Tumor 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 anlotinib in people with Sarcoma, Soft Tissue, run by Liaoning Cancer Hospital & Institute 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 7 inclusion and 21 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 9 Jul 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 Li Shenglong, master (18900918348, lishenglong@cancerhosp-ln-cmu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress free survival (time frame: Until Progressive Disease(PD) or death(up to 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03815474, which also lists 2 linked publications.
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 9 Jul 2019.