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

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.

Inclusion Criteria:Age: 18-75ECOG score: 0 or 1Unresectable advanced or recurrent gastric cancer/gastroesophageal junction cancerhistologically proven adenocarcinomaReceived chemotherapy based on platinum and fluorouracil within 12 monthsPatients not previously treated with paclitaxel or irinotecanLiver function: total bilirubin, ALT and AST<1.5 × ULN (Normal Value upper limit)Renal function: Cr<1.5 × ULN and creatinine clearance ≥ 40 ml/minEchocardiography or radionuclide cardiac function test, LVEF ≥ 50%Expected survival ≥ 3 monthsSign the informed consent formExclusion Criteria:Patients who have received irinotecan or paclitaxel chemotherapy in the pastECOG PS score:>2Advanced gastric cancer patients with extensive and severe peritoneal metastasisPatients with severe liver and kidney insufficiency or cardiac insufficiencyHIV positive, active hepatitis B or C, active pulmonary tuberculosisPatients with active autoimmune diseases, including lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, etcPatients known to be allergic to any of the study drugsPregnant or lactating female patients