A Prospective Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- complete response (CR) rate
研究概览
简要总结
The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-70 years old, female and male
- •pathological confirmed adenocarcinoma
- •clinical stage T1-3bN0, 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
Treatment Arm
A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TEM or TME surgery.
干预措施: PD-1 antibody (Drug)
Treatment Arm
A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TEM or TME surgery.
干预措施: Capecitabine (Drug)
Treatment Arm
A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TEM or TME surgery.
干预措施: Oxaliplatin (Drug)
Treatment Arm
A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TEM or TME surgery.
干预措施: Short-course radiotherapy (Radiation)
结局指标
主要结局
complete response (CR) rate
时间窗: The status of cCR will be evaluated after the completion of neoadjuvant therapy. The pCR rate will be evaluated after surgery. The cCR patients who adopted W&W strategy will be included into the CR rate caluculation.
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
- Organ preservation rate(from date of receiving neoadjuvant therapy, assessed up to 2 years)
- Grade 3-4 adverse effects rate(From date of initiation of treatment until the date of death from any cause, assessed up to 5 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.)
- 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.)
- 10 year Quality of Life(From date of initiation of treatment until the date of death from any cause, assessed up to 10 years)