NCT02717923Unknown2 期
Maintenance Treatment With Capecitabine Plus Cetuximab After First-line 5-Fluorouracil-based Chemotherapy Plus Cetuximab for Patients With RAS Wild-type Metastatic Colorectal Cancer: a Single Arm, Open-label, Multi-center Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression-Free Survival of maintaining treatment（mPFS）
研究概览
简要总结
This is a single arm, open-label, multi-center clinical trial to evaluate the efficacy and safety of maintenance treatment with capecitabine plus cetuximab after first-line 5-fluorouracil-based chemotherapy plus cetuximab for patients with RAS wild-type metastatic 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects has been fully understand this research and volunteered to sign the consent form;
- •Histologically and/or cytologically diagnosed with RAS wild-type metastatic metastatic colorectal cancer(Phase IIIc/IV), any other histological type is excluded;
- •Subjects with stable disease or better after induction treatment with eight to twelve 2-weekly cycles of 5FU-based standard chemotherapy;
- •ECOG Performance Status (ECOG PS) ≤1(0-1);
- •Evident measurable lesion(s) that meets the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
- •Expected survival>16 weeks.
排除标准
- •Subjects with presence of clinically detectable second primary malignant tumors at the enrollment, or other malignant tumors within the last 5 years (excluding adequately treated skin basal cell carcinoma or carcinoma in situ of cervix);
- •Clinical refractory diseases(including uncontrolled epilepsy),and affect survivor;
- •Central Nervous System (CNS) metastatic disease or prior cerebral metastasis;
- •Researchers think that the subjects exist any clinical or laboratory abnormalities or compliance issues and not suitable to participate in this clinical study.
研究组 & 干预措施
Maintenance Treatment
Experimental
A single arm of maintenance treatment with capecitabine plus cetuximab after first-line 5-fluorouracil based standard chemotherapy plus cetuximab.
干预措施: maintenance treatment with capecitabine plus cetuximab (Other)
结局指标
主要结局
Progression-Free Survival of maintaining treatment（mPFS）
时间窗: 5 years
mPFS defined as time from randomisation to progression after maintenance
次要结局
未报告次要终点
研究者
Xianglin Yuan
Professor, Chief physician
Huazhong University of Science and Technology
研究点 (1)
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