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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Raltitrexed:3mg/m2,iv,d1, Every 3 weeks
Paclitaxel:80mg/m2,iv,d1,d8, Every 3 weeks
Chinese Academy of Medical Sciences
Beijing, China
Objective Response Rate
Time frame: 18-26 months
Overall Survival
From date of randomization until date of death
Time frame: 18-26 months
Progression-free survival
From date of randomization until date of first documented PD, date of death
Time frame: 18-26 months
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