NCT07384234招募中2 期
SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: an Exploratory Study
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 2-year overall survival rate
研究概览
简要总结
This study is a prospective, randomized, two-cohort trial designed to evaluate the efficacy and safety of two regimens in the treatment of gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis: SHR-1701 combined with intravenous and intraperitoneal paclitaxel plus S-1, or SHR-1701 combined with CAPOX.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert typeⅡ and type Ⅲ gastroesophageal junction adenocarcinoma are eligible for inclusion).
- •Definitively diagnosed with peritoneal metastasis by exploratory laparoscopy and/peritoneal lavage cytology (CY0P1/CY1P0/CY1P1 are eligible, ovarian metastasis is permitted), and without gastric outlet obstruction or intestinal obstruction.
- •No prior anti-tumor treatment history (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Normal function of major organs.
排除标准
- •Known HER2-positive.
- •Previous history of gastric cancer surgery.
- •Contraindications to surgical treatment or chemotherapy, or poor physical status and organ function precluding major abdominal surgery.
- •Presence of distant metastases other than peritoneal metastases (e.g., liver, lung, ovarian, para-aortic lymph node, brain metastases, etc.).
- •Active autoimmune disease within 4 weeks prior to enrollment or a history of autoimmune disease.
- •Significant cardiovascular disease within 6 months prior to enrollment, including unstable angina or myocardial infarction.
研究组 & 干预措施
SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1
Experimental
干预措施: S-1 (Drug)
SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1
Experimental
干预措施: SHR-1701 (Drug)
SHR-1701 and CAPOX
Experimental
干预措施: SHR-1701 (Drug)
SHR-1701 and CAPOX
Experimental
干预措施: Capecitabine (Drug)
SHR-1701 and CAPOX
Experimental
干预措施: Oxaliplatin (Drug)
SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
2-year overall survival rate
时间窗: Up to 2 years
次要结局
- AEs(Up to 3 years)
- Conversion surgery rate(Up to 4 weeks after completion of surgery)
- R0 resection rate(Up to 4 weeks after completion of surgery)
- Pathological complete response(pCR)(Up to 4 weeks after completion of surgery)
- Tumor regression grade(Up to 4 weeks after completion of surgery)
- Event free survival (EFS)(Up to 2 years)
- DFS(Up to 2 years)
- Overall survival(OS)(Up to 3 years)
- AEs(Up to approximately 18 months)
研究者
研究点 (2)
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