SCRT Combined With CAPOX and PD-1 Antibody Versus LCRT Combined With CAPOX for Early Low-lying Rectal Cancer (TORCH-E3) (TORCH-E3)
A Prospective, Randomized, Phase III Clinical Trial Comparing Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for the Treatment of Early-stage Low Rectal Cancer.
TORCH-E3 is a prospective, multicentre, randomized phase III trial. 394 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 3y TME-free survival. The secondary endpoints include complete response (CR, pathological complete response [pCR] plus cCR) rate, the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Zhen Zhang, M.D, PH.D
- 电话号码：18801735029
- 邮箱：zhen_zhang@fudan.edu.cn
研究联系人备份
- 姓名：Yajie Chen Chen, PH.D
- 电话号码：18917239680
- 邮箱：16111230008@fudan.edu.cn
学习地点
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200030
- Fudan University Shanghai Cancer Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
- KPS >=70
- with good compliance
- microsatellite repair status is MSS/pMMR
- without previous anti-cancer therapy or immunotherapy
- signed the inform consent
Exclusion Criteria:
-
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.
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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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：SCRT plus immunochemotherapy group
Patients will receive SCRT (25Gy/5Fx, SCRT), followed by 4 cycles of CAPOX and PD-1 antibody, finally receive the TEM or TME surgery or adopt WW option. |
SCRT: 25Gy/5Fx Sintilimab 200mg d1 q3w
其他名称：
Oxaliplatin: 130mg/m2 d1 q3w Xeloda |
|
其他：LCRT plus chemotherapy group
Patients will receive LCRT (50Gy/25Fx,LCRT, concurrent capecitabine), followed by 2 cycles of CAPOX, finally receive the TEM or TME surgery or adopt WW option. |
Oxaliplatin: 130mg/m2 d1 q3w Xeloda LCRT: 50Gy/25Fx |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
3 year TME-free survival rate
大体时间：the proportion of patients who remain alive and have not undergone total mesorectal excision (TME) surgery within three years from the start of treatment.
|
Rate of 3 year TME-free survival |
the proportion of patients who remain alive and have not undergone total mesorectal excision (TME) surgery within three years from the start of treatment.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
3 year local recurrence free survival rate
大体时间：From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
|
Rate of 3 year local recurrence free survival |
From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
|
|
complete response (CR) rate
大体时间：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. |
1 month after the surgery or the decision of W&W
|
|
Organ preservation rate
大体时间：from date of receiving neoadjuvant therapy, assessed up to 3 years
|
Organ preservation rate |
from date of receiving neoadjuvant therapy, assessed up to 3 years
|
|
3 year disease free survival rate
大体时间：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.
|
Rate of 3 year disease free survival |
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 overall survival rate
大体时间：From date of initiation of treatment until the date of death from any cause, assessed up to 36 months
|
Rate of 3 year overall survival |
From date of initiation of treatment until the date of death from any cause, assessed up to 36 months
|
|
3 year Quality of Life
大体时间：From date of initiation of treatment until the date of death from any cause, assessed up to 3 years
|
Quality of life will be evaluated using EORTC QLQ-C30 score. |
From date of initiation of treatment until the date of death from any cause, assessed up to 3 years
|
|
Grade 3-4 adverse effects rate
大体时间：From date of randomization until 3 months after the completion neoadjuvant therapy
|
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events |
From date of randomization until 3 months after the completion neoadjuvant therapy
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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