Raltitrexed and Paclitaxel for Gastric or Gastroesophageal Junction Adenocarcinoma

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Paclitaxel; Raltitrexed

Criteria

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.