Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
Surgery with integrated treatment for metastatic colorectal cancer (mCRC) has created a new clinical setting known as mCRC with no evidence of disease (NED). However, these patients have a high risk of developing persistent cancer. This study aimed to investigate the efficacy and safety of Tislelizumab combined with capecitabine as a maintenance treatment for patients with mCRC-NED.
详细描述
This is a Phase 2, randomized, open-label, single-center study designed to compare the efficacy and safety of tislelizumab+ capecitabine versus best-supported care as a first-line maintenance treatment in participants with mCRC-NED.
Patients who underwent synchronously or staged removal of primary and metastatic lesions, achieving NED, and histologically confirmed colorectal adenocarcinoma were recruited in this trial. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and adverse events. This study will provide novel data on the efficacy and safety profile of the combination of tislelizumab and capecitabine in patients with mCRC-NED.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years, < 80 years
- •Written informed consent
- •Histologically or cytologically confirmed CRC
- •Surgery with integrated treatment for metastatic colorectal cancer (mCRC) and achieved a statute of no evidence of disease (NED), as determined by a multidisciplinary tumor board.
- •cytoreduction surgery achieves CC0 (no visible residual tumor) if there is peritoneal metastasis
- •No previous chemotherapy
- •Synchronous or metachronous metastatic disease: maximum of two distant organs or regions involved
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •Adequate hematologic and organ function
排除标准
- •Presence of any other active cancer
- •Presence of active infections requiring antibiotics
- •History of active autoimmune disease requiring systemic treatment
研究组 & 干预措施
Tislelizumab + Capecitabine
Tislelizumab 200mg every 3 weeks, or 1 year after completion of perioperative chemotherapy.
Capecitabine was given at a dose of 850 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy.
干预措施: Tislelizumab + Capecitabine (Drug)
Best supportive care
Best supportive care was the standard care in this setting.
干预措施: Best supportive care (Other)
结局指标
主要结局
Disease-free survival
时间窗: 36 months
The time from NED to the first occurrence of any of the following events: local relapse, distant metastasis, or death from any cause.
次要结局
- Adverse events(60 months)
- Overall survival(60 months)
研究者
Yanhong Deng
Professer
Sun Yat-sen University