A Multicenter Phase II Clinical Study of Radiotherapy Combined With Tislelizumab and Irinotecan in MSS/pMMR Inoperable Recurrence and Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Explore the efficacy of radiotherapy combined with Tislelizumab and irinotecan in MSS/pMMR inoperable recurrent and metastatic colorectal cancer patients; To evaluate the safety and tolerability of radiotherapy combined with Tislelizumab and irinotecan in MSS/pMMR inoperable recurrent and metastatic colorectal cancer; To evaluate the radiosensitization effects of Tslelizumab and irinotecan;
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary signing of informed consent;
- •Aged 18-70 years old, regardless of gender;
- •Histologically confirmed as inoperable recurrent or metastatic colorectal adenocarcinoma;
- •Previously received oxaliplatin and fluorouracil based chemotherapy; No previous treatment with irinotecan;
- •NGS sequencing or immunohistochemistry prompts MSS/pMMR
- •At least one measurable lesion;
- •Palliative radiotherapy is required for clinical evaluation (except radiotherapy for bone or brain metastasis);
- •ECOG scores 0-2;
- •Expected survival ≥ 6 months;
- •The organ function of the patient was normal within 7 days before treatment, and the function of important organs met certain requirements.
排除标准
- •Pregnant or breastfeeding women;
- •There were primary lesions or metastases in the radiation field and had received radiotherapy before;
- •Previously received PD-1, PD-L1 or PD-L2 for any indication;
- •Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ;
- •If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance;
- •Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months;
- •Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases;
- •Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC)≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP).
研究组 & 干预措施
Treatment group
Concurrent Chemoradiotherapy:
Radiation: The dose is determined according to the treatment site and the purpose of treatment.
Irinotecan: 80mg/m2/w (UGT1A1*28 and *6: 6/6+GG) or 65mg/m2/w (UGT1A1*28 and *6: 6/7+GG or 6/6+GA) or 50mg/m2/w (UGT1A1*28 and *6: 7/7+GG or 6/6+AA or 6/7+GA) Tislelizumab: 200mg ivgtt d1 q3w
Consolidation therapy: 2 weeks after the completion of chemoradiotherapy. Irinotecan: 200mg/m2 ivgtt d1 q3w. Tislelizumab: 200mg ivgtt d1 q3w. Efficacy assessment every 3 cycles.
干预措施: Tislelizumab (Drug)
Treatment group
Concurrent Chemoradiotherapy:
Radiation: The dose is determined according to the treatment site and the purpose of treatment.
Irinotecan: 80mg/m2/w (UGT1A1*28 and *6: 6/6+GG) or 65mg/m2/w (UGT1A1*28 and *6: 6/7+GG or 6/6+GA) or 50mg/m2/w (UGT1A1*28 and *6: 7/7+GG or 6/6+AA or 6/7+GA) Tislelizumab: 200mg ivgtt d1 q3w
Consolidation therapy: 2 weeks after the completion of chemoradiotherapy. Irinotecan: 200mg/m2 ivgtt d1 q3w. Tislelizumab: 200mg ivgtt d1 q3w. Efficacy assessment every 3 cycles.
干预措施: Irinotecan (Drug)
Treatment group
Concurrent Chemoradiotherapy:
Radiation: The dose is determined according to the treatment site and the purpose of treatment.
Irinotecan: 80mg/m2/w (UGT1A1*28 and *6: 6/6+GG) or 65mg/m2/w (UGT1A1*28 and *6: 6/7+GG or 6/6+GA) or 50mg/m2/w (UGT1A1*28 and *6: 7/7+GG or 6/6+AA or 6/7+GA) Tislelizumab: 200mg ivgtt d1 q3w
Consolidation therapy: 2 weeks after the completion of chemoradiotherapy. Irinotecan: 200mg/m2 ivgtt d1 q3w. Tislelizumab: 200mg ivgtt d1 q3w. Efficacy assessment every 3 cycles.
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Objective response rate
时间窗: 18 weeks after treatment completion
in radiation field
次要结局
未报告次要终点
研究者
Ji Zhu, MD
Professor
Zhejiang Cancer Hospital