NCT06404593已完成不适用
Dynamic ctDNA Detection for Guiding Adjuvant Therapy and Recurrence Monitoring After Curative Resection of Colorectal Cancer Liver Metastases: A Prospective Study
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2019年6月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
Evaluating the value of dynamic monitoring of a colorectal cancer liver metastasis cohort underwent curative resection after receiving multipoint ctDNA detecting in predicting recurrence prognosis and guiding adjuvant chemotherapy treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Before implementing any trial-related procedures, written informed consent should be signed;
- •>=20 and <= 85 years old, male or female;
- •Patients with liver metastases pathologically confirmed as colorectal adenocarcinoma;
- •According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one lesion that can be measured by imaging;
- •The multidisciplinary team (MDT) confirmed that the liver metastases were initially resectable ,without locally treatable extrahepatic metastases;
- •The general physical condition is good (ECOG score 0-1);
- •Life expectancy of more than 3 months;
- •There is no obvious symptoms of primary bleeding, obstruction and other indications for emergency surgery;
- •adequate organ function;
- •samples meet NGS quality control requirements;
- •The subjects are able and willing to comply with the visits, treatment plans, laboratory tests and other research-related procedures stipulated in the research protocol.
排除标准
- •Patients who are intolerant to systemic chemotherapy or surgery;
- •Patients with multiple primary lesions;
- •Blood samples and/or baseline tissue samples that do not meet the requirements for testing (hemolysis, low tumor cell content, insufficient DNA extraction yield, etc.);
- •Excessive tissue necrosis after conversion therapy, making it impossible to sample according to testing requirements
- •Patients who have not undergone surgery after conversion therapy, only receiving radiofrequency ablation or chemotherapy follow-up
- •Not all metastatic lesions were resected after conversion therapy, or liver metastatic lesions did not achieve R0 resection
- •No definite mutations detected in the tissue, or mutations detected in tumor tissue were not covered by the designed small panel.
结局指标
主要结局
progression-free survival
时间窗: 1 year
overall survival
时间窗: 5 year
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal CancerLiver MetastasesCirculating Tumor CellChemotherapy EffectColorectal CancerNCT05815082Sixth Affiliated Hospital, Sun Yat-sen University490
尚未招募
不适用
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract CarcinomaBiliary Tract CancerNCT06171321Shanghai East Hospital94
进行中（未招募）
不适用
Use of ctDNA for Monitoring of Stage III Colorectal CancerStage III Colorectal CancerNCT02842203University of Pittsburgh137
已完成
不适用
Evaluation ctDNA in Patients of Non-Small-Cell Lung Cancer Following ResectionNon-Small Cell Lung CancerNCT04238130Sun Yat-sen University132
Unknown
不适用
Circulating Tumor DNA (ctDNA) Monitoring in the Assessment and Prediction of the Efficacy of PARP Inhibitors (PARPi)Metastatic Castration-resistant Prostate CancerNCT05116579Sun Yat-sen University30