NCT05742425招募中2 期
The Efficacy and Safety of Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of pMMR/Ras/BRAF Wild-type Unresectable Colon Cancer Peritoneal Metastases: a Multicenter Single-arm Phase II Trial
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
Multicentric randomised trial. The goal of this clinical research study is to evaluate the efficacy and safety of serplulimab combined with FOLFIRI+bevacizumab in the treatment of pMMR/Ras/BRAF wild-type unresectable peritoneal metastasis of colon cancer.
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
- •Colon cancer was confirmed by histology, and its gene detection was pMMR/MSS and RAS/BRAF wild-type. Imaging showed peritoneal metastasis.
- •Peritoneal metastatic carcinoma that could not reach CC0/1 was detected surgically.
- •Patients with the following general characteristics:
- •Age between 18 and 75 years
- •Performance Status (ECOG) 0, 1 or 2, life expectancy > 12 weeks
- •Adequate renal, and bone marrow function: a. Leukocytes >/= 3,000/microL; b. Absolute neutrophil count >/= 1,500/microL; c. Platelets >/= 100,000/Ul; d. Serum creatinine </= 1.5 mg/dL
- •Hepatic function: AST (SGOT)/ALT (SGPT) </= 5 X institutional (Upper Limit of Normal) ULN.
- •Able to tolerate immunotherapy, chemotherapy and surgery.
- •Patients will be informed and a signed consent before initiating any procedure specific to the trial.
排除标准
- •Age >75years or age<18years.
- •Cancers of non colonic origin.
- •History of cancer (excepted cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years.
- •Known HIV, Hepatitis B or Hepatitis C positive.
- •Pregnant women or likely to be pregnant.
- •Persons under guardianship.
- •Subjects deemed unable to comply with study and/or follow-up procedures.
- •Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
研究组 & 干预措施
One-arm research group
Experimental
干预措施: Serplulimab Combined With FOLFIRI and Bevacizumab (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 3 years
The period from the beginning of treatment to the first occurrence of disease progression or death from any cause. If such situation is not met, the last evaluation date shall be used for analysis. In addition, if the treatment is terminated without confirming the progress of the disease, the imaging examination and follow-up should also be carried out after the treatment is terminated.
次要结局
- 3-year overall survival (OS)(3 years)
- Objective Remission Rate (ORR)(3 months after preoperative chemotherapy)
- CC0/1 resection rate(during operation)
- Incidence rate of adverse events(Baseline before any treatment,3 months after any treatment)
研究者
研究点 (1)
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