A Randomized, Controlled, Multicenter Phase II Study of Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 184
- 主要终点
- Objective Response Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
B: Camrelizumab+Irinotecan
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
干预措施: Camrelizumab (Drug)
A: Camrelizumab+Albumin-bound paclitaxel
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
干预措施: Camrelizumab (Drug)
A: Camrelizumab+Albumin-bound paclitaxel
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
干预措施: Albumin-Bound Paclitaxel (Drug)
B: Camrelizumab+Irinotecan
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
干预措施: Irinotecan (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: up to 12 weeks
CR+PR
次要结局
- Progression-free Survival(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(24 months)
- Overall Survival(From date of randomization until the date of date of death from any cause, assessed up to 24 months)
- Quality of life assessment(24 months)