A Prospective, Randomized, Phase II Trial of Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- complete response (CR) rate
研究概览
简要总结
TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is complete response (CR, pathological complete response [pCR] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-75 years old, female and male
- •pathological confirmed adenocarcinoma
- •clinical stage T1-3bN0-1, tumor maximum diameter less than 4cm
- •the distance from anal verge less than 5 cm
- •without distance metastases
- •with good compliance
- •microsatellite repair status is MSS/pMMR
- •without previous anti-cancer therapy or immunotherapy
- •signed the inform consent
排除标准
- •pregnancy or breast-feeding women
- •pathological confirmed signet ring cell carcinoma
- •clinical stage T1N0 and can be resected locally
- •history of other malignancies within 5 years
- •serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
- •immunodeficiency disease or long-term using of immunosuppressive agents
- •baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
- •DPD deficiency
- •allergic to any component of the therapy
研究组 & 干预措施
Long-course Radiotherapy plus chemotherapy group
The patients will receive long-course radiotherapy (50Gy/25Fx,LCRT, concurrent capecitabine), followed by 2 cycles of CAPOX, finally receive the TEM or TME surgery or adopt WW option.
干预措施: Long-course radiotherapy (Radiation)
Short-course Radiotherapy plus immunochemotherapy group
The patients will receive short-course radiotherapy (25Gy/5Fx, SCRT), followed by 4 cycles of CAPOX and PD-1 antibody, finally receive the TEM or TME surgery or adopt WW option.
干预措施: Short-course radiotherapy (Radiation)
Short-course Radiotherapy plus immunochemotherapy group
The patients will receive short-course radiotherapy (25Gy/5Fx, SCRT), followed by 4 cycles of CAPOX and PD-1 antibody, finally receive the TEM or TME surgery or adopt WW option.
干预措施: PD-1 antibody (Toripalimab) (Drug)
Short-course Radiotherapy plus immunochemotherapy group
The patients will receive short-course radiotherapy (25Gy/5Fx, SCRT), followed by 4 cycles of CAPOX and PD-1 antibody, finally receive the TEM or TME surgery or adopt WW option.
干预措施: Oxaliplatin (Drug)
Short-course Radiotherapy plus immunochemotherapy group
The patients will receive short-course radiotherapy (25Gy/5Fx, SCRT), followed by 4 cycles of CAPOX and PD-1 antibody, finally receive the TEM or TME surgery or adopt WW option.
干预措施: Capecitabine (Drug)
Long-course Radiotherapy plus chemotherapy group
The patients will receive long-course radiotherapy (50Gy/25Fx,LCRT, concurrent capecitabine), followed by 2 cycles of CAPOX, finally receive the TEM or TME surgery or adopt WW option.
干预措施: Oxaliplatin (Drug)
Long-course Radiotherapy plus chemotherapy group
The patients will receive long-course radiotherapy (50Gy/25Fx,LCRT, concurrent capecitabine), followed by 2 cycles of CAPOX, finally receive the TEM or TME surgery or adopt WW option.
干预措施: Capecitabine (Drug)
结局指标
主要结局
complete response (CR) rate
时间窗: 1 month after the surgery or the decision of W&W
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy.
次要结局
- Grade 3-4 adverse effects rate(From date of randomization until 3 months after the completion neoadjuvant therapy)
- Organ preservation rate(from date of receiving neoadjuvant therapy, assessed up to 3 years)
- 3 year local recurrence free survival rate(From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.)
- 3 year overall survival rate(From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.)
- 3 year Quality of Life(From date of initiation of treatment until the date of death from any cause, assessed up to 3 years)
- 3 year disease free survival rate(From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.)