NCT07054879招募中不适用
A Prospective Single-center Observational Study: ctDNA-guided Maintenance Therapy for Postoperative Pancreatic Cancer
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 2-year DFS rate
研究概览
简要总结
This study aims to conduct a large-scale prospective clinical trial to evaluate the efficacy and safety of capecitabine monotherapy as maintenance treatment following standard adjuvant chemotherapy (gemcitabine plus capecitabine) in patients with resectable pancreatic cancer, and to analyze whether ctDNA-MRD testing can guide the selection of postoperative maintenance therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, male or female
- •Histologically or cytologically confirmed primary diagnosis of pancreatic ductal adenocarcinoma (PDAC)
- •No evidence of distant metastasis (M0)
- •Underwent R0 radical resection within 3 months prior to enrollment
- •ECOG performance status of 0-1
- •Life expectancy ≥3 months
- •Patient or legal guardian is able to understand the study requirements and willing to provide written informed consent
排除标准
- •Prior history of radiotherapy, chemotherapy or surgical treatment for pancreatic cancer
- •Concurrent severe organ dysfunction or hematologic disorders
- •Tumor involvement of celiac axis or superior mesenteric artery, locally advanced disease, or presence of distant metastases
- •Poor general condition deemed unable to tolerate chemotherapy
- •History of other malignancies within past 5 years (except adequately treated carcinoma in situ of cervix or basal cell carcinoma of skin)
- •Any severe or uncontrolled systemic disease that may affect risk/benefit assessment, including but not limited to: uncontrolled hypertension, active hepatitis B or C infection, HIV infection
- •Patient or guardian unable to comprehend study objectives and requirements
- •Any other condition that in the investigator's judgment would make the patient unsuitable for study participation
结局指标
主要结局
2-year DFS rate
时间窗: At the timepoint of 2 years after surgery
the proportion of cancer patients who remain free of disease recurrence or death from any cause within 2 years after surgery
次要结局
未报告次要终点
研究者
Du Juan
Chief Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
研究点 (1)
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