Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA: an Open, Prospective, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Detection rate of NeoRAS WT
研究概览
简要总结
Following systemic therapy in metastatic colorectal cancer(mCRC),RAS (including KRAS, NRAS and HRAS gene) status may change from a mutant(MT) to a wild-type(WT),a phenomenon known as "NeoRAS WT"mCRC.NeoRAS WT can be detected by longitudinal circulating tumor DNA(ctDNA) analysis.Therefore, this prospective phase II Study was design to explore the detection rate of peripheral blood ctDNA testing for NeoRAS WT and its guiding value for subsequent treatment for mCRC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic colorectal cancer with tissue RAS mutation-type;
- •ECOG (Eastern Cooperative Oncology Group) performance score is 0-1;
- •Obtaining informed consent;
- •Surgical specimens or punctured tissue specimens containing tumors can be obtained; 10ml of peripheral blood can be obtained
排除标准
- •The pathology was not confirmed by colonoscopy biopsy or biopsy of metastasis;
- •Colorectal cancer patients with clinical stage I-III;Patients with RAS wild-type metastatic colorectal cancer confirmed by histological genetic testing;Lack of adequate organ functions, such as severe abnormalities in blood, liver and kidney function
研究组 & 干预措施
RAS mutated metastatic colorectal cancer
RAS mutated metastatic colorectal cancer were routinely treated after enrollment. When the disease progression was confirmed by imaging, peripheral blood ctDNA detection was performed to observe whether they were transformed into NeoRAS wild-type patients. If NeoRAS wild- type was detected, the anti-EGFR therapy may be considered as the following therapy for patients.
干预措施: Cetuximab (Drug)
结局指标
主要结局
Detection rate of NeoRAS WT
时间窗: up to 60 months
Proportion of occurrence of neoRAS WT
次要结局
- Overall survival (OS) in NeoRAS WT patients(Follow-up was conducted for 2 years after enrollment)
- Objective response rate(ORR) of NeoRAS wild-type patients receiving anti-EGFR therapy(Follow-up was conducted for 2 years after enrollment)
- Progression-free survival (PFS) in NeoRAS WT patients(Follow-up was conducted for 2 years after enrollment)