SCRT Combined With CAPOX and PD-1/CTLA4 Antibody for Early-stage Low Rectal Cancer
The Combination of PD-1/CTLA4 Antibody and Neoadjuvant Short-course Radiotherapy in Early-stage Low Rectal Cancer
The study evaluates the combination of immunotherapy of PD-1/ CTLA4 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/ CTLA4 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.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 阶段2
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 18801735029
- 邮箱：zhen_zhang@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, 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.
- 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：不适用
- 介入模型：单组作业
- 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：Treatment Arm
A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1/CTLA4 antibody, finally receive the TEM or TME surgery. |
Shor-course radiotherapy: 25Gy/5Fx Iparomlimab and Tuvonralimab, 5mg/kg, d1 q3w Capecitabine: 1000mg/m2 d1-14 q3w 130mg/m2 d1 q3w |
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 |
|---|---|---|
|
complete response (CR) rate
大体时间：From date of receiving neoadjuvant therapy, assessed up to 2 years
|
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy. |
From date of receiving neoadjuvant therapy, assessed up to 2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Organ preservation rate
大体时间：From date of receiving neoadjuvant therapy, assessed up to 2 years
|
Rate of patients who underwent organ preservation via WW or TEM after neoadjuvant therapy |
From date of receiving neoadjuvant therapy, assessed up to 2 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 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.
|
|
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.
|
|
10 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 10 years
|
Patient self-assessment via EORTC QLQ-C30 questionnaire to monitor changes in quality of life throughout treatment. |
From date of initiation of treatment until the date of death from any cause, assessed up to 10 years
|
|
Grade 3-4 adverse effects rate
大体时间：From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
|
Incidence and severity of treatment side effects graded by NCI CTCAE v5.0. |
From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
|
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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