NCT03083613

Raltitrexed and Paclitaxel for Gastric or Gastroesophageal Junction Adenocarcinoma

Phase II Trial of Raltitrexed and Paclitaxel as Second-line Chemotherapy for Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Raltitrexed	Raltitrexed:3mg/m2,iv,d1, Every 3 weeks
DRUG	Paclitaxel	Paclitaxel:80mg/m2,iv,d1,d8, Every 3 weeks

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-09-01
• Completion: 2018-12-01
• First posted: 2017-03-20
• Last updated: 2021-02-01

Locations

1 site across 1 country: China