Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 3y LRFS
研究概览
简要总结
This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy.
详细描述
A total of 60 patients with high-risk pathologic stage pT1 or pT2 cancer after local excision but refused radical surgery will be included.
Eligibility criteria include a histological diagnosis of adenocarcinoma located ≤7 cm from the anal verge, pT1 after local excision of the primary rectal cancer, with one of the high-risk features including margin positivity/very close margin (<1mm) at time of local excision, depth of invasion >1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.
They will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody.
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 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
- •the distance from anal verge ≤ 7 cm
- •pT1 after local excision of the primary rectal cancer, with at least one of the high-risk features including margin positivity/very close margin (<1mm) at time of local excision, depth of invasion >1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.
- •refuse radical surgery
- •without pelvic or 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
- •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
Arm1
Patients will receive short course radiotherapy and four cycles of CapeOx and PD-1 inhibitor.
干预措施: Radiation (Radiation)
Arm1
Patients will receive short course radiotherapy and four cycles of CapeOx and PD-1 inhibitor.
干预措施: PD-1 antibody (Drug)
Arm1
Patients will receive short course radiotherapy and four cycles of CapeOx and PD-1 inhibitor.
干预措施: Capecitabine (Drug)
Arm1
Patients will receive short course radiotherapy and four cycles of CapeOx and PD-1 inhibitor.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
3y LRFS
时间窗: 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 rate
次要结局
- 3y DFS(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.)
- Grade 3-4 adverse effects rate(From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.)
- 3y OS(From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.)