NCT05035381Unknown2 期
Phase II Clinical Study on Efficacy and Safety of PD-1 Inhibitor Combined With Bevacizumab and FOLFIRI Regimen in the Second-line Treatment of Unresectable Recurrent or Metastatic MSI-H Colorectal Cancer
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
MSI-H is a biomarker for solid tumors benefiting from immunotherapy. Recent clinical studies have confirmed that PD-1 inhibitors have a good effect on MSI-H advanced colorectal cancer for first- or second-line treatment. The overall effective rate is 30% to 40%. However, about 30% of patients are resistant to PD-1 inhibitors. Whether PD-1 inhibitors and existing chemotherapeutics and anti-vascular drugs have synergistic effects is worth studying. This study is a phase II prospective clinical study of PD-1 inhibitor combined with bevacizumab and FOLFIRI regimen in the second-line treatment of unresectable recurrent or metastatic MSI-H colorectal cancer.
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
- •Recurrent or metastatic unresectable colorectal adenocarcinoma confirmed by histology and/or cytology;
- •First-line oxaliplatin-containing chemotherapy has disease progression during chemotherapy or within 6 months after chemotherapy;
- •MSI-H patients confirmed by pathology, MSH2(-) or MSH6(-), for MLH1(-) or PMS2(-) patients need PCR confirmation;
- •According to the RECIST 1.1 standard, there is at least one measurable lesion；
- •Sufficient bone marrow function, liver and kidney function；
- •age greater than 18 years old， less than or equal to 75 years old；
- •ECOG score 0 or 1; expected survival time greater than 3 months; signed informed consent.
排除标准
- •For patients who have been treated with PD-1 in the first-line treatment, bevacizumab is allowed in the first-line treatment;
- •Other malignant tumors have been diagnosed within 5 years before the first use of the study drug, except for effectively treated skin basal cell carcinoma, skin squamous cell carcinoma, and/or effectively resected in situ cervical cancer and/or breast cancer;
- •Suffer from any active autoimmune disease or have a history of autoimmune disease;
- •Are suffering from an active infection that requires systemic treatment;
- •The HIV test result is positive;
- •Known to be allergic to certain components of the research drug or similar drugs;
- •Use clinical investigational drugs within 4 weeks before the start of study administration;
- •Major surgery has been performed within 4 weeks before the start of the study administration and has not fully recovered;
- •The patient has a bleeding disorder, and the investigator judges that there is a risk of hemorrhage;
- •Uncontrolled cardiac clinical symptoms or disease heart function, such as severe arrhythmia, uncontrollable hypertension;
- •According to the judgment of the investigator, the subject has other factors that may cause him to be forced to suspend the study.
研究组 & 干预措施
Experiment Group
Experimental
干预措施: Pembrolizumab (PD-1 Inhibitor) Combined With Bevacizumab and FOLFIRI Regimen (Drug)
结局指标
主要结局
Objective response rate
时间窗: Up to one year
次要结局
- Disease Control Rate(Up to 2 years)
- Progression-free survival(up to 2 years)
- Overall survival(up to 3 years)
- Adverse Events(up to one year)
研究者
研究点 (1)
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