NCT06279351招募中2 期
Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer
Xinqiao Hospital of Chongqing1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年8月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- ETS
研究概览
简要总结
- To verify that thalidomide can increase the efficacy of cetuximab plus chemotherapy in the treatment of stage IV RAS and BRAF wild-type unresectable left colorectal cancer, which has important clinical significance and provides a basis for subsequent large-scale research and clinical application.
- To evaluate the changes of cytokines and verify the effect of some cytokines on the efficacy of cetuximab +FOLFIRI, so as to provide a scientific basis for the subsequent precise therapy using cytokines antibodies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients with RAS and BRAF wild-type IV unresectable left colorectal cancer confirmed by pathology and tissue/cytology and genetic testing;
- •Physical state is good: PS 0-2;
- •Expected survival of more than 3 months;
- •Aged 18-75 years old;
- •Have not received systematic chemotherapy before;
- •Did not receive cetuximab treatment;
- •Liver, kidney and bone marrow functions are basically normal;
- •The clearance period of chemotherapy and molecular targeted therapy is more than 4 weeks;
- •Voluntary participation in the group, good compliance, can cooperate with the experiment observation, and sign the written informed consent.
排除标准
- •Patients with severe dysfunction of vital organs (heart, liver, kidney);
- •Patients with other malignant tumors;
- •Patients who are pregnant or breastfeeding (women of childbearing age need to check pregnancy test);
- •In the active phase of acute or chronic infectious diseases;
- •People with a clear history of drug allergy or allergic constitution;
- •Patients participating in other clinical trials;
- •Other conditions in which the patient was considered inappropriate to participate in the study.
研究组 & 干预措施
Test group
Experimental
Thalidomide+cetuximab+FOLFOX/FOLFIRI
干预措施: Thalidomide+cetuximab+FOLFOX/FOLFIRI (Drug)
结局指标
主要结局
ETS
时间窗: 8 weeks
Early tumor shrinkage
次要结局
- ORR(8 weeks)
- DCR(8 weeks)
- PFS(1 year)
研究者
Jianguo Sun
Deputy director of oncology department, Clinical Professor
Xinqiao Hospital of Chongqing
研究点 (1)
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