Phase IV Study Assessing Efficacy of First-Line Chemotherapy With Gemcitabine in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients Ineligible to FOLFIRINOX Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of alive GemCore+ patients treated with Gemcitabine
研究概览
简要总结
The goal of this interventional study is to learn about the efficacy of first-line chemotherapy with Gemcitabine in metastatic pancreatic adenocarcinoma patients expressing the GemCore signature in their tumor. The main question it aims to answer is to assess efficacy of Gemcitabine (tumor response, survival rate) in the population of patient bearing the GemCore signature.
Participants will start the chemotherapy with Gemcitabine as usually performed in standard care of their center. They will consent to a genomic analyze of their tumor to know if it bears the GemCore signature. The center will manage the participant's follow up as usually realized in standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Metastatic pancreatic adenocarcinoma histological proved
- •FOLFIRINOX chemotherapy-ineligible patient and going to receive first-line metastatic chemotherapy with gemcitabine monotherapy
- •Tumor material allowing assessment of GEMCore status (i.e. FFPE block with tumor cellularity ≥ 10%);
- •Life expectancy > 2 months;
- •Measurable target according to RECIST 1.1 criteria;
- •No previous treatment in metastatic situation;
- •Age ≥ 18 years;
- •Patient not opposed to study participation;
- •Affiliation to a social security system, or beneficiary of such a scheme.
排除标准
- •Contraindication to Gemcitabine treatment;
- •ECOG performance status ≥ 3;
- •Person in emergency situation or unable to express non-opposition;
- •Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice);
- •Unable to undergo medical follow-up for geographical, social or psychological reasons.
结局指标
主要结局
Percentage of alive GemCore+ patients treated with Gemcitabine
时间窗: 12 months
Percentage of alive GemCore+ patients treated with Gemcitabine
次要结局
- Overall survival(24 months)
- Tumor response rate(24 months)
- Progression-free survival(24 months)