Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma: A Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Specificity of postoperative ctDNA in monitoring recurrence and metastasis
研究概览
简要总结
In recent years, circulating tumor DNA (ctDNA)had achieved encouraging results in monitoring recurrence and metastasis after surgery, and has potential clinical application value. The presence of ctDNA after surgery predicts very poor recurrence-free survival, whereas its absence predicts a low risk of recurrence. The benefit of adjuvant chemotherapy for ctDNA-positive patients is not well understood.
详细描述
The results of the PRODIGE-12/ACCORD-18 study showed that, with a median follow-up of 47 months, the adjuvant chemotherapy arm did not lead to a significant improvement in recurrence-free survival (RFS) and overall survival (OS). Notably, the patients with gallbladder cancer experienced adjuvant chemotherapy significantly worse RFS and OS compared to those in the monitoring arm. ctDNA risk stratifies patients to guide adjuvant treatment decisions This study aimed to demonstrate that a escalation strategy of ctDNA guided adjuvant chemotherapy is superior to standard of care treatment as measured by 2 year disease free survival (DFS) in patients with stage II- III biliary tract cancers with minimal residual disease (MRD) (ctDNA positive).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically confirmed BTCs according to the UICC/AJCC TNM staging system (8th edition 2017) for stage II-III tumours. Patients eligible for radical resection of BTCs. No synchronous or metastatic malignant tumour found in other organs other than the primary tumor.
- •Personal status (PS) score as over 80 or Eastern Cooperative Oncology Group (ECOG) score as 0 ~
- •3）With expected survival of more than 12 months. 4) Radical operation performed.
排除标准
- •Patients with positive surgical margins and residual lesions after biliary tract tumor surgery.
- •Blood transfusion performed during operation or within 2 weeks before operation.
- •Have a history of other malignant tumors within 5 years.
研究组 & 干预措施
Group 2: Patients with a positive ctDNA test are treated with an escalation strategy
Postoperative ctDNA-positive patients receive intravenous combined oral Teysuno (S-1) for adjuvant therapy。
干预措施: S-1(Intravenous combined with oral) (Drug)
结局指标
主要结局
Specificity of postoperative ctDNA in monitoring recurrence and metastasis
时间窗: Up to 60 months
Number of patients with ctDNA negative and no recurrence and metastasis confirmed by imaging / number of patients with no recurrence and metastasis confirmed by imaging
ctDNA guided adjuvant chemotherapy versus Translational sub study
时间窗: Up to 60 months
To demonstrate the superiority of an escalation strategy of ctDNA-guided adjuvant chemotherapy over standard-of-care treatment, 2-year disease-free survival (DFS) was measured as 2-year Disease-Free Survival (DFS) in high-risk stage II-III BTC patients with no evidence of minimal residual disease (ctDNA-negative).
Accuracy of postoperative ctDNA in monitoring recurrence and metastasis
时间窗: Up to 60 months
True positive/ctDNA-positive samples
Sensitivity of postoperative ctDNA in monitoring recurrence and metastasis
时间窗: Up to 60 months
Number of patients with ctDNA positive and imaging confirmed recurrence or metastasis / number of all imaging confirmed recurrence or metastasis
次要结局
- overall survival (OS)(From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months.)
- ctDNA clearance rate(Up to 60 months)