NCT05802407招募中不适用
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in resected pancreatic cancer. The main questions it aims to answer are:
- prognostic value of baseline MRD;
- the role of MRD dynamic changes after treatment in guiding treatment. Peripheral blood derived from participants will be obtained for MRD test before adjuvant chemotherapy initiation and at the first imaging assessment after chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with pancreatic cancer who had undergone curative-intent surgery (R0 or R1 resection);
- •both sexes, age ≥18 years old;
- •ECOG performance status score ≤2;
- •the expected survival time was ≥3 months.
排除标准
- •a known diagnosis of pancreatic cancer other than ductal adenocarcinoma;
- •treated with any systemic antitumor treatment before first-line chemotherapy onset;
- •died or lost to follow-up within one month after the initiation of adjuvant chemotherpay;
- •combined with other primary malignances.
研究组 & 干预措施
MRD-guided
Experimental
Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will receive a later-line therapy.
干预措施: Later-line therapy (Drug)
结局指标
主要结局
Disease-free survival
时间窗: Baseline until death from any cause (up to approximately 36 months)
The date of adjuvant chemotherpay initiation to tumor recurrence, local-regional or distant metastases, or death due to any cause.
次要结局
- Overall survival(Baseline until death from any cause (up to approximately 60 months))
研究者
研究点 (1)
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