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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
200mg d1, the first day, every 14 days as a cycle
100 mg/m2, the 1st, 8th and 15th days, every 28 days as a cycle
180 mg/m2, the first day, every 14 days as a cycle
Objective Response Rate
CR+PR
Time frame: up to 12 weeks
Overall Survival
Time from random start of treatment to death from any cause
Time frame: 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
Time frame: 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
Time frame: 24 months
Quality of life assessment
according to EORTC C30
Time frame: 24 months
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