Predicting the Efficacy of Paclitaxel Plus Ramucirumab in Advanced Gastric Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Chemotherapy response
研究概览
简要总结
With advances in chemotherapy for gastric cancer, it is important to identify patients who will respond effectively to specific therapies. This longitudinal study aimed to establish a liquid-biopsy assay that can predict response to ramucirumab plus paclitaxel therapy in patients with advanced gastric cancer.
详细描述
The combination of paclitaxel and ramucirumab is a potent standard second-line therapy for patients with advanced gastric cancer, but approximately 30% of patients do not respond to treatment. Failure to respond to second-line therapy can lead not only to disease progression, but also to deterioration of the patient's health and loss of the opportunity to receive other treatments that originally had the potential to be curative. This study aims to predict the efficacy of second-line treatment (paclitaxel plus ramucirumab) in patients with gastric cancer using liquid biopsies (small RNA). Prediction using pre-treatment blood may allow patients who do not respond to treatment to choose other treatment options. This study aims to establish a tool that will enable noninvasive pre-treatment selection, which could lead to personalized treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unresectable or recurrent GC histologically confirmed to be primary adenocarcinoma of the stomach.
- •age over 20 years.
- •Eastern Cooperative Oncology Group performance status score of 0-
- •written informed consent following full study information is provided to the patient.
- •progression or intolerance for first-line chemotherapy comprising fluorinated pyrimidine and platinum anticancer drugs (cisplatin or oxaliplatin) for advanced GC.
- •presence of evaluable lesions as confirmed using a computed tomography (CT) or magnetic resonance imaging.
排除标准
- •Patients with a life expectancy of shorter than 3 months
- •Patients with severe complications (angina pectoris, myocardial infarction, or arrhythmia) or uncontrollable diabetes mellitus, blood hypertension, or bleeding tendency.
- •Patients with a history of serious allergic reactions or serious drug allergy.
- •Patients with a clinically relevant mental disorder that prohibits response to questionnaires.
- •Patients for whom the attending physician considered that enrollment in the study is inappropriate.
研究组 & 干预措施
Gastric cancer chemotherapy responders received second-line chemotherapy
Responders according to the response evaluation criteria in solid tumors (RECIST).
A panel of microRNA, whose expression level is tested exosomal microRNA from blood sample before second-line chemotherapy with reverse transcriptase quantitative polymerase chain reaction (RT-qPCR)
干预措施: Paclitaxel (Drug)
Gastric cancer chemotherapy non-responders received second-line chemotherapy
Non-responders according to the response evaluation criteria in solid tumors (RECIST).
A panel of microRNA, whose expression level is tested exosomal microRNA from blood sample before second-line chemotherapy with reverse transcriptase quantitative polymerase chain reaction (RT-qPCR)
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Chemotherapy response
时间窗: 2 years
Follows by response valuation criteria in solid tumors (RECIST) evaluation. Partial response (PR) and Stable disease (SD) are defined as treatment effective, while Progressive disease (PD) is defined as no treatment effective.
次要结局
未报告次要终点