Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

Study Overview
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Brief Summary
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This study is a multicenter, open, and randomized clinical phase II exploratory study. The pick the winner study design is used to determine and select which chemotherapy drug (irinotecan vs. albumin plus paclitaxel) is more effective in the second-line treatment of advanced gastric cancer, and it is more hopeful to carry out the follow-up phase III study in the second-line treatment of advanced gastric cancer (karelizumab+chemotherapy vs. chemotherapy). The study plans to include 184 patients with advanced gastric cancer who have received first-line platinum+fluorouracil progression, randomly use albumin paclitaxel+carrelizumab or irinotecan+carrelizumab second-line therapy, and observe the objective effective rate (ORR), total survival time (OS), progression free survival time (PFS), treatment related adverse reactions, quality of life and other clinical indicators after receiving the above treatment, Then determine the second line scheme which is more advantageous.

Official Title
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A Randomized, Controlled, Multicenter Phase II Study of Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

Conditions
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Second Line Treatment of Gastric Cancer

Intervention / Treatment
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* Drug: Camrelizumab
* Drug: Albumin-Bound Paclitaxel
* Drug: Irinotecan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-75 ECOG score: 0 or 1 Unresectable advanced or recurrent gastric cancer/gastroesophageal junction cancer histologically proven adenocarcinoma Received chemotherapy based on platinum and fluorouracil within 12 months Patients not previously treated with paclitaxel or irinotecan Liver function: total bilirubin, ALT and AST<1.5 × ULN (Normal Value upper limit) Renal function: Cr<1.5 × ULN and creatinine clearance ≥ 40 ml/min Echocardiography or radionuclide cardiac function test, LVEF ≥ 50% Expected survival ≥ 3 months Sign the informed consent form Exclusion Criteria: Patients who have received irinotecan or paclitaxel chemotherapy in the past ECOG PS score:>2 Advanced gastric cancer patients with extensive and severe peritoneal metastasis Patients with severe liver and kidney insufficiency or cardiac insufficiency HIV positive, active hepatitis B or C, active pulmonary tuberculosis Patients with active autoimmune diseases, including lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, etc Patients known to be allergic to any of the study drugs Pregnant or lactating female patients

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Camrelizumab+Albumin-bound paclitaxel<br>Camrelizumab 200mg d1, one cycle every 14 days on the first day; albumin binding paclitaxel: 100 mg/m2, one cycle every 28 days on the first, eighth and fifteenth days | Drug: Camrelizumab<br>* 200mg d1, the first day, every 14 days as a cycle<br>* Other names: Camrel;Drug: Albumin-Bound Paclitaxel<br>* 100 mg/m2, the 1st, 8th and 15th days, every 28 days as a cycle<br>* Other names: ABP;|
| Experimental: B: Camrelizumab+Irinotecan<br>Camrelizumab 200mg d1, the first day, every 14 days as a cycle Irinotecan: 180 mg/m2, the first day, every 14 days as a cycle | Drug: Camrelizumab<br>* 200mg d1, the first day, every 14 days as a cycle<br>* Other names: Camrel;Drug: Irinotecan<br>* 180 mg/m2, the first day, every 14 days as a cycle<br>* Other names: Iri;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | CR+PR | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Time from random start of treatment to death from any cause | From date of randomization until the date of date of death from any cause, assessed up to 24 months | 
| Progression-free Survival | Time from random start of treatment to death or tumor progression due to any reason | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | 
| Treatment related adverse reactions | Evaluation according to CTC 4.0 | 24 months | 
| Quality of life assessment | according to EORTC C30 | 24 months |