A Pilot Study of Molecular Profile-Directed Chemotherapy for Metastatic HER2(-) Esophagogastric Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- The Number of Patients With Tumor Size Reduction (Objective Response Rate)
研究概览
简要总结
The purpose of this study is to determine whether molecular profile-directed therapy (otherwise known as personalized treatment) can improve the effectiveness of standard chemotherapy combinations for patients with esophagogastric adenocarcinoma. A series of tests will be performed on a sample of tumor; based on the results of these tests, a patient will be assigned to a chemotherapy treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Advanced, measurable metastatic esophagogastric adenocarcinoma by RECIST criteria
- •Patients who have had surgery or radiotherapy with or without neoadjuvant or adjuvant chemotherapy (the wash-out period will be at least 1 month)
- •Patients who are not eligible for resection and are chemotherapy naïve
- •Patients with HER2(-) status
- •Patients who have tumor deposit(s) that are easily accessible by ultrasound or CT guidance
- •Patients must have adequate organ function
- •Patients must provide written informed consent
排除标准
- •Active concurrent malignancy, other than superficial, non-squamous cell carcinoma of the skin or uterine cervix, within the past three years
- •ECOG performance status worse than 2
- •Prior oral or intravenous chemotherapy for metastatic disease
- •Patients with comorbidities that prevent them from being able to receive the chemotherapy regimen
- •cardiac ejection fraction 45% or greater
研究组 & 干预措施
Chemotherapy
Standard chemotherapy doublet based on molecular testing using one of the following interventions:
Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
干预措施: Modified FOLFOX6 (Drug)
Chemotherapy
Standard chemotherapy doublet based on molecular testing using one of the following interventions:
Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
干预措施: Docetaxel/Capecitabine (Drug)
Chemotherapy
Standard chemotherapy doublet based on molecular testing using one of the following interventions:
Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
干预措施: Cisplatin/Irinotecan (Drug)
Chemotherapy
Standard chemotherapy doublet based on molecular testing using one of the following interventions:
Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
干预措施: Cisplatin/Docetaxel (Drug)
Chemotherapy
Standard chemotherapy doublet based on molecular testing using one of the following interventions:
Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
干预措施: IRI/EPI (Drug)
Chemotherapy
Standard chemotherapy doublet based on molecular testing using one of the following interventions:
Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
干预措施: EPI/Docetaxel (Drug)
Chemotherapy
Standard chemotherapy doublet based on molecular testing using one of the following interventions:
Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
干预措施: Irinotecan/Docetaxel (Drug)
Chemotherapy
Standard chemotherapy doublet based on molecular testing using one of the following interventions:
Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
干预措施: Docetaxel (Drug)
结局指标
主要结局
The Number of Patients With Tumor Size Reduction (Objective Response Rate)
时间窗: 1 year
Objective response rate is the sum of partial responses plus complete responses and will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
次要结局
未报告次要终点