A Phase II Multicenter Clinical Trial of Modified Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Complete response (CR) rate
研究概览
简要总结
To explore the complete response (CR) rate of modified short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer
详细描述
In the neoadjuvant treatment of rectal cancer, the new mode of short-course radiotherapy and chemotherapy combined with immunotherapy has shown good potential for application. Combining PD-1 antibody with short-course radiotherapy and chemotherapy to increase the tumour-killing and immune-mediated effects of the radiation dose may further improve tumour regression and increase the complete remission rate, providing a promising treatment option for patients with low-grade rectal cancer who are seeking a 'wait-and-see' strategy to preserve organ function.
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, any gender.
- •Pathologically confirmed rectal adenocarcinoma.
- •Baseline MR stage T3-4/N+.
- •Distance from anal verge ≤12cm.
- •No distant metastasis.
- •Karnofsky Performance Status ≥
- •Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy.
- •Microsatellite/mismatch repair status MSS/pMMR.
- •No prior chemotherapy or any other anti-tumor treatment before inclusion.
- •No prior immunotherapy.
- •Ability to comply with the study protocol during the study period.
- •Signed written informed consent.
排除标准
- •Pregnant or lactating women.
- •Pathological diagnosis of signet ring cell carcinoma.
- •History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
- •Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
- •Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
- •Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
- •Patients with autoimmune diseases.
- •Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
- •Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10^9/L; platelets ≥100×10^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin <1.5 times the upper limit of normal; serum creatinine <1 times the upper limit of normal; serum albumin ≥30g/L.
- •Known deficiency of dihydropyrimidine dehydrogenase (DPD).
- •Allergy to any investigational drug components.
研究组 & 干预措施
Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab
Modified SCRT (GTV 30Gy/5f, CTV 22.5Gy/5f), followed by Tislelizumab and CAPOX q3w *2 cycles. Efficacy and surgery were assessed 2-4 weeks after the end of treatment.
干预措施: Short-course Radiotherapy (Radiation)
Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab
Modified SCRT (GTV 30Gy/5f, CTV 22.5Gy/5f), followed by Tislelizumab and CAPOX q3w *2 cycles. Efficacy and surgery were assessed 2-4 weeks after the end of treatment.
干预措施: Tislelizumab (Drug)
Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab
Modified SCRT (GTV 30Gy/5f, CTV 22.5Gy/5f), followed by Tislelizumab and CAPOX q3w *2 cycles. Efficacy and surgery were assessed 2-4 weeks after the end of treatment.
干预措施: Capecitabine (Drug)
Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab
Modified SCRT (GTV 30Gy/5f, CTV 22.5Gy/5f), followed by Tislelizumab and CAPOX q3w *2 cycles. Efficacy and surgery were assessed 2-4 weeks after the end of treatment.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Complete response (CR) rate
时间窗: From enrollment to 3 month and during follow-up
Including pCR and CCR.
次要结局
- Organ preservation rate(1 year.)
- Quality of life(Before each treatment, before surgery and during follow-up.)
- 3y-DFS(From enrollment to 36 month)
- 3-year OS(From enrollment to 36 month)