NCT05802394招募中不适用
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced 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
- Resection rate
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 borderline resectable or locally advanced 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 conversion therapy 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 histologically confirmed borderline resectable or locally advanced pancreatic cancer;
- •conversion therapy was planned;
- •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 first-line 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
Resection rate
时间窗: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
Proportion of patients who receive surgical resection
次要结局
- Overall survival(Baseline until PD or death, whichever occurs first (up to approximately 24 months))
- Progression-free survival(Baseline until PD or death, whichever occurs first (up to approximately 24 months))
- R0 resection rate(Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months))
- Major pathological response(Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months))
研究者
研究点 (1)
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