Short-course Radiotherapy Combined With CAPOX and Pd-1 Inhibitor for Locally Advanced Colon Cancer: a Randomized, Prospective, Multicentre, Phase II Trial (TORCH-C)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- pCR
研究概览
简要总结
The study evaluates the combination of immunotherapy of PD-1 antibody and chemotherapy and neoadjuvant short-course radiotherapy in locally advanced colon cancer (LACC). Patients are randomly assigned into two prospective groups: treatment group and observerment group. In treatment group, a total of 60 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 surgery. In observerment group: a total of 60 patients will receive 4 cycles of CAPOX chemotherapy, then receive the surgery. The rate of pathologic complete response （pCR）, long-term prognosis and adverse effects will be analyzed.
详细描述
This study is a prospective, randomized controlled, multicenter phase II study, with a design of superior efficacy，to compare the efficacy of neoadjuvant short-course radiotherapy combined with CapOX chemotherapy and PD-1 immunotherapy in locally advanced colon cancer. We will consecutively enrolled patients who were diagnosed with locally advanced colon cancer with T4 stage or bulky nodes. A total of 120 patients will be Randomized 1:1 to the treatment group and observerment group. In observerment group, patients will receive 4 cycles of CAPOX (Capecitabine: 1000mg/m2 d1-14 q3w; Oxaliplatin: 130mg/m2 d1 q3w)chemotherapy, then receive the surgery, followed by 4 cycles of CAPOX. In treatment group, patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOXand PD-1 antibody(Serplulimab,300mg d1 q3w), then receive the surgery,followed by 4 cycles of 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
- •pathological confirmed adenocarcinoma
- •clinical stage T4 and/or bulky nodes
- •the distance from anal verge more than 15 cm
- •without distance metastases
- •age >=18 years old, female and male
- •without previous anti-cancer therapy or immunotherapy
- •with good compliance
- •signed the inform consent
排除标准
- •pregnancy or breast-feeding women
- •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
- •allergic to any component of the therapy
研究组 & 干预措施
short-course radiotherapy and immunotherapy
A total of 60 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the surgery.
干预措施: Serplulimab (Drug)
short-course radiotherapy and immunotherapy
A total of 60 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the surgery.
干预措施: short-term radiotherapy (Radiation)
short-course radiotherapy and immunotherapy
A total of 60 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the surgery.
干预措施: Oxaliplatin (Drug)
short-course radiotherapy and immunotherapy
A total of 60 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the surgery.
干预措施: Capecitabine (Drug)
chemotherapy
A total of 60 patients will receive 4 cycles of CAPOX chemotherapy ,then receive the surgery.
干预措施: Oxaliplatin (Drug)
chemotherapy
A total of 60 patients will receive 4 cycles of CAPOX chemotherapy ,then receive the surgery.
干预措施: Capecitabine (Drug)
结局指标
主要结局
pCR
时间窗: The pCR rate will be evaluated after surgery, an average of 4 weeks
pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes
次要结局
- Grade 3-4 adverse effects rate(From date of randomization until the date of death from any cause, assessed up to 5 years)
- Surgical complications(The surgery was scheduled 2-4 weeks after the end of neoadjuvant therapy. And the surgical complications were assessed up to 5 years from the surgery)
- R0 resection rate(The R0 resection rate will be evaluated after surgery, an average of 4 weeks)
- 3 year overall survival rate(From date of randomization until the date of death from any cause, assessed up to 3 years)
- 3 year disease free survival rate(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.)
- 3 year local recurrence free survival rate(From date of randomization until the date of first documented local-regional failure, assessed up to 3 years)