SCAFIGC：Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- 6-month PFS%
研究概览
简要总结
This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer(patients with HER2 negative and PD-L1 CPS≥5).Patiens will recevie Serplulimab plus chemotherapy ((oxaliplatin+capecitabine) as first-line treatment. After PD，patients will randomly 2：1 assigned to treatment：one group will receive Serpluimab with Paclitaxel,Apatinib；another group will receive Paclitaxel with or without Ramucirumab.All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent
详细描述
stage one ：Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+oxaliplatin130mg/m2 iv.gtt d1+capecitabine 1000mg/m2 p.o.b.i.d d1~d14,q3w
stage two:Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+Apatinib 250mg/qd+Paclitaxel 135~175mg/m2 iv.gtt,d1,q3w
Paclitaxel 135~175mg/m2 iv.gtt,d1,q3w±Ramucirumab 8mg/kg,d1,q2w
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
- •Age ≥ 18 years and ≤ 75 years when ICF is signed;
- •Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
- •never received systemic anti-tumor drug therapy before；
- •HER2 negative and PD-L1 CPS≥5;
- •Measurable lesion according to RECIST v1.1 by IRRC;
- •ECOG score 0-1;
排除标准
- •Has other active malignancies within 5 years before the first administration of the study drug;
- •Plan to or have previously received organ or bone marrow transplantation;
- •Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- •Have received any research drugs within 14 days before the first use of the study drugs.
研究组 & 干预措施
continuation of Serplulimab plus chemotherapy after first progression
Serplulimab+Paclitaxel+Apatinib
Paclitaxel±Ramucirumab
干预措施: Serplulimab+Paclitaxel+Apatinib (Drug)
continuation of Serplulimab plus chemotherapy after first progression
Serplulimab+Paclitaxel+Apatinib
Paclitaxel±Ramucirumab
干预措施: Paclitaxel±Ramucirumab (Drug)
结局指标
主要结局
6-month PFS%
时间窗: The Percent of patinets after first progression until disease progression in 6 months
Progression-free survival by IRRC assessment per RECIST 1.1
次要结局
- PFS1(From date of randomization until the date of first documented progressionor date of death from any cause, whichever came first)
- OS(From the date of first dose unitl the date of death from any cause，assessed up to 2 years ])
- PFS2(From date of randomization until the date of second-line treatment progression or date of death from any cause, whichever came first)