Phase II Trial of Raltitrexed and Paclitaxel as Second-line Chemotherapy for Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a single-arm clinical trial.The purpose of this study is to evaluate the efficacy and safety of Raltitrexed and Paclitaxel as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma .The primary endpoint of this study is objective response rate.The secondary endpoint of this study is safety,progression-free survival and overall survival.
详细描述
Raltitrexed is an antifolate thymidylate synthase inhibitor that has shown efficacy and good safety profile in the treatment of colorectal cancer. To our knowledge, there has been no study published with the Raltitrexed and Paclitaxel regimen as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.The aim of our study was to evaluate the efficacy, safety and survival of this regimen in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
- •Patients failed first-line chemotherapy containing fluoropyrimidines and platinums;
- •ECOG (Eastern Cooperative Oncology Group)performance status 0-1;
- •At least 1 measurable lesion should be present（RECIST1.1）
- •Available Organ function: Neutrophils>2g/L, Hemoglobin>9g/L, Blood platelet >100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)<1.0 ULN; Cr <1.0ULN
- •Signed informed consent.
- •Life expectancy ≥3 months;
排除标准
- •Previous treatment with Raltitrexed or Paclitaxel;
- •Known history of allergic reaction to Raltitrexed or Paclitaxel;
- •Known brain metastases;
- •Pregnant or breast feeding women;
- •Severe diarrhea,intestinal obstruction;
- •other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix);
- •Previous myocardial infarction, unstable angina, stroke ,or uncontrollable Arrhythmia;
- •Kown HIV infecton.
研究组 & 干预措施
Raltitrexed and Paclitaxel
All patients receive the combination therapy of Raltitrexed and Paclitaxel for a maximum of 6 cycles
Raltitrexed:3mg/m2,d1 Paclitaxel:80mg/m2,d1,d8,
Eery 3 weeks
干预措施: Raltitrexed (Drug)
Raltitrexed and Paclitaxel
All patients receive the combination therapy of Raltitrexed and Paclitaxel for a maximum of 6 cycles
Raltitrexed:3mg/m2,d1 Paclitaxel:80mg/m2,d1,d8,
Eery 3 weeks
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 18-26 months
次要结局
- Overall Survival(18-26 months)
- Progression-free survival(18-26 months)
研究者
Aiping Zhou
Chief physician
Chinese Academy of Medical Sciences