A Phase II Multicenter Clinical Trail of Efficacy and Safety of Short Course Radiotherapy Combined With CAPOX and PD-1/CTLA-4 Bispecific Antibody QL1706 in Patients With Liver Metastases From Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Progression-free-Survival
研究概览
简要总结
To enhance the treatment efficacy of rectal cancer liver metastasis through a multidisciplinary approach of radiotherapy, immunotherapy, and chemotherapy, and to provide a new direction for the combination treatment strategy.
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 cancer with liver metastases (stage M1).
- •Karnofsky Performance Status ≥
- •Adequate organ function, no contraindications to 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
Short course radiotherapy combined with CAPOX and QL1706
Two cycles of CAPOX combined with QL1706 were followed by a short course of radiotherapy (CTV 25Gy/5f) and finally two cycles of CAPOX and QL1706.
干预措施: Short course radiotherapy (Radiation)
Short course radiotherapy combined with CAPOX and QL1706
Two cycles of CAPOX combined with QL1706 were followed by a short course of radiotherapy (CTV 25Gy/5f) and finally two cycles of CAPOX and QL1706.
干预措施: Capecitabine (Drug)
Short course radiotherapy combined with CAPOX and QL1706
Two cycles of CAPOX combined with QL1706 were followed by a short course of radiotherapy (CTV 25Gy/5f) and finally two cycles of CAPOX and QL1706.
干预措施: Oxaliplatin (Drug)
Short course radiotherapy combined with CAPOX and QL1706
Two cycles of CAPOX combined with QL1706 were followed by a short course of radiotherapy (CTV 25Gy/5f) and finally two cycles of CAPOX and QL1706.
干预措施: QL1706 (Drug)
结局指标
主要结局
Progression-free-Survival
时间窗: from enlrollment to 36month
次要结局
- Toxic reaction rate above 3rd degree(from enlrollment to 36month)
- relapse-free survival(from enlrollment to 36month)
- overall survival(from enlrollment to 36month)