Gastric CancerPhase 1/2NCT05608785
Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes
A Phase 1/2 study testing IBI315, Oxaliplatin and Capecitabine in people with Gastric Cancer and Gastroesophageal-junction Cancer, run by Henan Cancer Hospital.
Trial summary
Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal-junction Cancer
- What is being tested?
- IBI315, Oxaliplatin and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Oct 2024
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form for this study.
- Male or female patients aged 18-75 years.
- unresectable advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (including indolent cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by pathological (histological or cytological) examination.
- >6 months from the end of prior (neo)adjuvant chemotherapy/adjuvant radiotherapy to the time of disease recurrence
- at least one measurable lesion or evaluable lesion according to RECIST version 1.1; measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be optional targets if progression is confirmed and they meet RECIST 1.1 criteria)
- ECOG score: 0 to 1.
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- Life expectancy ≥ 3 months.
- Adequate organ function, with the following laboratory test values required at screening.
- Routine blood test criteria to be met. Hemoglobin level (HB) ≥ 90 g/L (no blood transfusion within 14 days). Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelet count (PLT) ≥100×109/L (no interleukin 11 or TPO within 14 days). White blood cell count (WBC) ≥4.0×109/L (no granulocyte stimulating factor within 14 days).
- Biochemical tests are required to meet the following criteria. Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). ALT and AST ≤ 2.5 ULN. Cr ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60 ml/min, (Cockcroft-Gault formula).
- Serum albumin ≥ 25 g/L (2.5 g/dL). For subjects with liver metastases, AST and ALT must be ≤ 5 x ULN, leukocytes ≥ 4 x 109/L, untransfused platelets ≥ 100 x 109/L, absolute neutrophil value (ANC) without granulocyte-stimulating factor treatment ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L
- Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%).
- Adequate coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN.
- Women of childbearing potential are required to use highly effective contraception for the duration of the study, and for the period after the last dose and for at least 180 days after chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration; non-sterile men are required to use highly effective contraception for the duration of the study and for at least 180 days after both the last dose and chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration.
- If local treatment of metastases, such as radiotherapy or ablation, is performed, they may also be enrolled after 14 days of washout as long as an assessable lesion is still present and the local treatment is not followed by anti-tumor therapy such as targeted, chemotherapy or immunotherapy.
Who cannot join
- Hypersensitivity to any of the test drugs and their excipients, or a history of severe allergy, or a contraindication to the test drug.
- A history or active stage of autoimmune disease.
- symptomatic/asymptomatic brain metastases
- CT suggestive of definite ulcerative lesions or positive fecal occult blood (risk of bleeding and suitability for enrollment as determined by the investigator)
- History of abnormal bleeding (except epistaxis) complained of 14 days prior to enrollment
- previous allogeneic bone marrow transplantation or organ transplantation
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- congenital pulmonary fibrosis, drug-induced pneumonia, mechanized pneumonia, or CT-confirmed active pneumonia
- HIV positive test, active hepatitis B or C, active tuberculosis.
- Uncontrolled cancer pain.
- previous live attenuated vaccine within 4 weeks prior to study entry or expected to be administered during or within 5 months of the end of the trial
- Prior treatment with PD-1/PD-L1 antibodies, CTLA-4 antibodies, or other therapies targeting PD-1/PD-L1 and/or VEGFR inhibitors or have not recovered from adverse events caused by dosing >4 weeks prior (i.e., have not returned to ≤ grade 1 or baseline levels)).
- Systemic application of glucocorticoids or immunosuppressants within 2 weeks prior to trial start (note: inhaled glucocorticoids and salicorticoids are permitted).
- Known presence of symptomatic CNS metastases and/or carcinomatous meningitis. Patients with a history of CNS metastases or spinal cord compression may be enrolled in the study if they are clearly treated and clinically stable after discontinuation of anticonvulsants and steroids for 4 weeks prior to the first dose of the study.
- Have a contraindication to hormone use.
- Have multiple factors that interfere with oral drug administration (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction)
- peripheral neuropathy ≥ NCI CTCAE grade 2.
- Uncontrollable or symptomatic hypercalcemia.
- infections requiring antibiotics within 14 days prior to the start of the trial
- chronic enterocolitis.
- Patients with bone metastases at risk of paraplegia.
- Patients with any severe and/ or uncontrolled disease, including: Patients with suboptimal blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) on antihypertensive medications; patients with class II or higher myocardial ischemia or myocardial infarction, arrhythmias (including QT interval ≥ 480 ms); class III-IV cardiac insufficiency by NYHA criteria, or cardiac ultrasound suggestive of left ventricular ejection fraction ( LVEF) <50% in patients. Active or uncontrolled severe infections. Liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis. Poorly controlled diabetes mellitus (fasting blood glucose (FBG) >10 mmol/L). Urine routine suggestive of urine protein ≥++ and confirmed 24-hour urine protein quantification >1.0 g.
- Long-term untreated wounds or fractures 23) Subjects who are unable to receive a trans-peripheral central venous placement (PICC)
- Subjects with abnormal coagulation (INR > 1.5 or APTT > 1.5 × ULN), with bleeding tendency or on thrombolytic or anticoagulant therapy. Known hereditary or acquired bleeding and thrombotic tendencies such as: hemophilia, impaired coagulation skills, thrombocytopenia, hypersplenism, etc. Active bleeding within 14 prior to study entry.
- Major surgical procedure (craniotomy, open-heart or open-heart surgery) within 4 weeks prior to the first dose of study, or anticipated need for major surgery during study treatment, or non-diagnostic surgery within 4 weeks prior to the start of the trial.
- history of gastrointestinal perforation and/or fistula within 3 months prior to enrollment in treatment; or arterial/venous thrombotic events such as cerebrovascular accidents (except stable cerebral infarction as assessed by the investigator), deep vein thrombosis, and pulmonary embolism (except if cured)
- Clinically significant thoracoabdominal fluid, including any thoracoabdominal fluid that is detectable on physical examination, previously treated or currently still requiring treatment Those with only a small amount of thoracic ascites on imaging but asymptomatic, which the investigator assesses does not require treatment may be enrolled.
- Interstitial lung disease requiring steroid hormone therapy.
- uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary reactions to cancer that can lead to higher medical risk and/or uncertainty in survival evaluation
- Patients with significant malnutrition.
- Patients with a history of psychotropic substance abuse and inability to abstain or with psychiatric disorders
- those with a history of immunodeficiency, including testing positive for HIV or having other acquired, congenital immunodeficiency disorders, or a history of organ transplantation
- History of other primary malignancies, except for 1) malignancies in complete remission for at least 2 years prior to enrollment and requiring no other treatment during the study period; 2) non-melanoma skin cancers or malignant freckled nevi that have been adequately treated and have no evidence of disease recurrence; and 3) carcinomas in situ that have been adequately treated and have no evidence of disease recurrence.
- Female patients who are pregnant or breastfeeding.
- those who, in the judgment of the investigator, have a serious concomitant disease that jeopardizes patient safety or interferes with the patient's ability to complete the study
- Participating in another trial within 30 days prior to the start of the trial, or planning to participate in another trial while the trial is ongoing.
- Inclusion in the row with the most stringent conditions, if there is duplication.
About this study
Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types.
Evaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria.
Read more
RECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT).
Per-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form.
Safety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set.
Statistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented.
Safety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred.
Treatment protocol:
All subjects in this study were first tested for genes/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene/protein expression.
Group 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment.
Principal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital
- Conditions
- Gastric Cancer, Gastroesophageal-junction Cancer
- Being tested
- IBI315, Oxaliplatin, Capecitabine, TST001, TQB2450
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI315Drug
IBI315 is a recombinant fully humanized anti-programmed death receptor 1 (PD-1) and humanized anti-human epidermal growth factor receptor 2 (HER2) bispecific antibody injection.
OxaliplatinDrug
Oxaliplatin is a type of chemotherapy. It is used as a treatment for different types of cancer, including gastric cancer.
CapecitabineDrug
Capecitabine is a type of chemotherapy. It is used as a treatment for different types of cancer, including gastric cancer.
TST001Drug
TST001 is a high-affinity humanized monoclonal antibody targeting Claudin 18.2 with enhanced antibody-dependent cytotoxic (ADCC) and complement-dependent cytotoxic (CDC) activity, showing potent antitumor activity in xenograft assays.
TQB2450Drug
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
AnrotinibDrug
Anlotinib is a novel multitarget tyrosine kinase inhibitor for tumor angiogenesis and proliferative signaling.
| Study group | Role | What they receive |
|---|---|---|
| HER2 protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification | Experimental | Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine
* IBI315: 1200 mg per cycle d1 dosing, intravenous drip, 3 weeks as one treatment cycle.
* Oxaliplatin: 130 mg/m2, d1 per cycle, intravenous drip, 3 weeks as a treatment cycle.
* Capecitabine: 1000 mg/m2 orally twice daily (1 dose in the morning and 1 dose in the evening), d1-d14 per cycle, 2 weeks off 1 week, 3 weeks cycle.
Patients with CR/PR/SD enter maintenance therapy: IBI315 monotherapy maintenance
- IBI315: 1200 mg IV drip per cycle d1 for 3 weeks. Receives: Drug: IBI315; Drug: Oxaliplatin; Drug: Capecitabine |
| Positive for Claudin 18.2 protein | Experimental | Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine
* TST001: 3mg, 4.5mg and 6mg dose levels for hill climbing trial, dose per cycle d1, IV drip, 3 weeks for one treatment cycle. 3-6 patients were enrolled in each dose level (3 patients were enrolled if no DLT was present, if present extended to 6 patients)
* TQB2450 injection: 1200 mg per cycle d1 dosing, IV drip, 3 weeks as a treatment cycle.
* Oxaliplatin: 130 mg/m2 per cycle d1 dosing, intravenous drip, 3 weeks as a treatment cycle.
* Capecitabine: 1000 mg/m2 orally twice daily (1 dose in the morning and 1 dose in the evening), d1-d14 per cycle, 2 weeks off 1 week, 3 weeks cycle.
Patients with CR/PR/SD enter maintenance therapy: TQB2450 injection + TST001
* TST001: maintenance at the dose level used (3mg/4.5mg/6mg), dosed d1 per cycle, IV drip, 3 weeks as a treatment cycle.
* TQB2450 injection: 1200mg, dosed d1 per cycle, intravenous drip, 3 weeks as a treatment cycle. Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: TST001; Drug: TQB2450 |
| Her2 protein, Claudin18.2 protein were negative | Experimental | Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine
* TQB2450 injection: 1200mg per cycle d1 dosing, intravenous drip, 3 weeks as a treatment cycle.
* Anrotinib: 1 capsule (10 mg) once daily, dosed every cycle d1-d14, stopping for 2 consecutive weeks, 3 weeks as a treatment cycle
* Oxaliplatin: 130 mg/m2, d1 per cycle, intravenous drip, 3-week treatment cycle.
* Capecitabine: 1000 mg/m2 orally twice daily (1 dose in the morning and 1 dose in the evening), d1-d14 per cycle, 2 weeks off 1 week, 3 weeks as a treatment cycle.
Patients with CR/PR/SD enter maintenance therapy: PD-L1 inhibitor, anlotinib
* PD-L1 monoclonal antibody (TQB2450): 1200 mg d1 per cycle, intravenous drip, 3 weeks as a treatment cycle.
* Anlotinib: 1 capsule (10mg) once daily, d1-d14 per cycle, stopping for 2 weeks, 3 weeks as a treatment cycle. Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: TQB2450; Drug: Anrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
An adverse event contains multiple severity grades, typically the start date is the date of mild (grade 1) occurrence, the end date is the date of improvement, and the level is filled in at the highest level.
Measured: up to 100 months
Secondary outcomes (6)
Objective response rate，ORR
The remission period is usually defined as the period from the onset of efficacy until the confirmation of tumor progression. The objective remission rate is generally defined as the sum of complete remission plus partial remission (CR+PR).
Measured: up to 100 months
Duration of Response, DoR
Time from when the patient first achieved complete remission or partial remission to disease progression.
Measured: up to 100 months
progression-free survival，PFS
Time from randomization grouping of patients to disease progression or death from any cause.
Measured: up to 100 months
overall survival，OS
From date of randomization until the date of death from any cause, assessed up to 100 months
Measured: up to 100 months
disease control rate，DCR
Proportion of patients who achieve complete remission, partial remission, or disease control with optimal efficacy
Measured: up to 100 months
R0/R1 resection rate
R0/R1 resection rate
Measured: up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608785
- Sponsor's protocol ID
- GC-MATCH
- Status last verified
- Aug 2022
- First submitted
- 15 Sep 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes
- ClinicalTrials.gov ID
- NCT05608785
- Acronym / sponsor ID
- GC-MATCH
- Conditions
- Gastric Cancer, Gastroesophageal-junction Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 8 Nov 2022 (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.
Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types.
Evaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria.
RECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT).
Per-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form.
Safety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set.
Statistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented.
Safety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred.
Treatment protocol:
All subjects in this study were first tested for genes/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene/protein expression.
Group 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment.
Principal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HER2 protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification | Experimental | Drug: IBI315, Drug: Oxaliplatin, Drug: CapecitabineInitial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine * IBI315: 1200 mg per cycle d1 dosing, intravenous drip, 3 weeks as one treatment cycle. * Oxaliplatin: 130 mg/m2, d1 per cycle, intravenous drip, 3 weeks as a treatment cycle. * Capecitabine: 1000 mg/m2 orally twice daily (1 dose in the morning and 1 dose in the evening), d1-d14 per cycle, 2 weeks off 1 week, 3 weeks cycle. Patients with CR/PR/SD enter maintenance therapy: IBI315 monotherapy maintenance - IBI315: 1200 mg IV drip per cycle d1 for 3 weeks. |
| Positive for Claudin 18.2 protein | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Drug: TST001, Drug: TQB2450Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine * TST001: 3mg, 4.5mg and 6mg dose levels for hill climbing trial, dose per cycle d1, IV drip, 3 weeks for one treatment cycle. 3-6 patients were enrolled in each dose level (3 patients were enrolled if no DLT was present, if present extended to 6 patients) * TQB2450 injection: 1200 mg per cycle d1 dosing, IV drip, 3 weeks as a treatment cycle. * Oxaliplatin: 130 mg/m2 per cycle d1 dosing, intravenous drip, 3 weeks as a treatment cycle. * Capecitabine: 1000 mg/m2 orally twice daily (1 dose in the morning and 1 dose in the evening), d1-d14 per cycle, 2 weeks off 1 week, 3 weeks cycle. Patients with CR/PR/SD enter maintenance therapy: TQB2450 injection + TST001 * TST001: maintenance at the dose level used (3mg/4.5mg/6mg), dosed d1 per cycle, IV drip, 3 weeks as a treatment cycle. * TQB2450 injection: 1200mg, dosed d1 per cycle, intravenous drip, 3 weeks as a treatment cycle. |
| Her2 protein, Claudin18.2 protein were negative | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Drug: TQB2450, Drug: AnrotinibInitial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine * TQB2450 injection: 1200mg per cycle d1 dosing, intravenous drip, 3 weeks as a treatment cycle. * Anrotinib: 1 capsule (10 mg) once daily, dosed every cycle d1-d14, stopping for 2 consecutive weeks, 3 weeks as a treatment cycle * Oxaliplatin: 130 mg/m2, d1 per cycle, intravenous drip, 3-week treatment cycle. * Capecitabine: 1000 mg/m2 orally twice daily (1 dose in the morning and 1 dose in the evening), d1-d14 per cycle, 2 weeks off 1 week, 3 weeks as a treatment cycle. Patients with CR/PR/SD enter maintenance therapy: PD-L1 inhibitor, anlotinib * PD-L1 monoclonal antibody (TQB2450): 1200 mg d1 per cycle, intravenous drip, 3 weeks as a treatment cycle. * Anlotinib: 1 capsule (10mg) once daily, d1-d14 per cycle, stopping for 2 weeks, 3 weeks as a treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Voluntarily sign the informed consent form for this study.
- Male or female patients aged 18-75 years.
- unresectable advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (including indolent cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by pathological (histological or cytological) examination.
- >6 months from the end of prior (neo)adjuvant chemotherapy/adjuvant radiotherapy to the time of disease recurrence
- at least one measurable lesion or evaluable lesion according to RECIST version 1.1; measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be optional targets if progression is confirmed and they meet RECIST 1.1 criteria)
Key exclusion criteria (36 listed)
- Hypersensitivity to any of the test drugs and their excipients, or a history of severe allergy, or a contraindication to the test drug.
- A history or active stage of autoimmune disease.
- symptomatic/asymptomatic brain metastases
- CT suggestive of definite ulcerative lesions or positive fecal occult blood (risk of bleeding and suitability for enrollment as determined by the investigator)
- History of abnormal bleeding (except epistaxis) complained of 14 days prior to enrollment
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 |
|---|---|---|
| IBI315IBI315 is a recombinant fully humanized anti-programmed death receptor 1 (PD-1) and humanized anti-human epidermal growth factor receptor 2 (HER2) bispecific antibody injection. | Drug | HER2 protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification |
| OxaliplatinOxaliplatin is a type of chemotherapy. It is used as a treatment for different types of cancer, including gastric cancer. | Drug | HER2 protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification, Her2 protein, Claudin18.2 protein were negative, Positive for Claudin 18.2 protein |
| CapecitabineCapecitabine is a type of chemotherapy. It is used as a treatment for different types of cancer, including gastric cancer. | Drug | HER2 protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification, Her2 protein, Claudin18.2 protein were negative, Positive for Claudin 18.2 protein |
| TST001TST001 is a high-affinity humanized monoclonal antibody targeting Claudin 18.2 with enhanced antibody-dependent cytotoxic (ADCC) and complement-dependent cytotoxic (CDC) activity, showing potent antitumor activity in xenograft assays. | Drug | Positive for Claudin 18.2 protein |
| TQB2450TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. | Drug | Her2 protein, Claudin18.2 protein were negative, Positive for Claudin 18.2 protein |
| AnrotinibAnlotinib is a novel multitarget tyrosine kinase inhibitor for tumor angiogenesis and proliferative signaling. | Drug | Her2 protein, Claudin18.2 protein were negative |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: up to 100 months
An adverse event contains multiple severity grades, typically the start date is the date of mild (grade 1) occurrence, the end date is the date of improvement, and the level is filled in at the highest level.
6 secondary outcomes
Objective response rate，ORR
Time frame: up to 100 months
Duration of Response, DoR
Time frame: up to 100 months
progression-free survival，PFS
Time frame: up to 100 months
overall survival，OS
Time frame: up to 100 months
disease control rate，DCR
Time frame: up to 100 months
R0/R1 resection rate
Time frame: up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IBI315, Oxaliplatin and Capecitabine in people with Gastric Cancer and Gastroesophageal-junction Cancer, run by Henan Cancer Hospital.
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 15 inclusion and 36 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 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. (time frame: up to 100 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 8 Nov 2022.