NCT05380414招募中不适用
A Single-center, Prospective Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- Number of patients with at least one actionable alteration defined as an alteration shown to predict for sensitivity to a drug FDA/EMA approved for use in another cancer type, or a relevant alteration for inclusion in a clinical trial.
研究概览
简要总结
The proposal is to implement a molecular screening program for advanced/metastatic pancreatic cancer patients before the initiation of 1st line treatment in order to allow a better selection of patients for rationale personalized medicine with targeted agents and/or combination involving a chemotherapy backbone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Male or female patient > 18 years
- •metastatic or advanced PDAC
- •Patient pretreated with no more than one prior systemic chemotherapy for metastatic/advanced disease (radiotherapy is not counted as a line of therapy).
- •Availability of an archival representative FFPE tumor sample from primary tumor (surgery or diagnostic biopsy) and/or from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block.
- •Life expectancy > 3 months
- •PS score 0 or 1.
排除标准
- •Curative therapy available
- •Any condition contraindicated with blood sampling procedures required by the protocol.
- •Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer.
- •Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
结局指标
主要结局
Number of patients with at least one actionable alteration defined as an alteration shown to predict for sensitivity to a drug FDA/EMA approved for use in another cancer type, or a relevant alteration for inclusion in a clinical trial.
时间窗: At the end of study (5 years)
次要结局
- Overall survival (OS)(Up to 12 months)
- Duration of response (DoR)(Up to 12 months)
- Best overall response (BoR)(Up to 12 months)
- Progression-Free Survival (PFS)(Up to 12 months)
- Time from ICF signature to day 1 of next line of therapy(At day 1)
- Number of patients initiating a targeted therapy according to this molecular screening program with type of therapy initiated(At the end of study (5 years))
研究者
研究点 (2)
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