drugset / Trial / NCT02370849

Cisplatin and S-1 With or Without Nimotuzumab in Untreated Advanced Gastric Adenocarcinoma

NCT02370849

Phase 2 Completed 2 enrolled Chinese Academy of Medical Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

In this open-label, single-center, small sample size, randomised, parallel-group, controlled study, the investigators aim to assess efficacy and safety of addition of nimotuzumab to CS chemotherapy in patients with previously untreated advanced gastric adenocarcinoma. Sixty-two patients are required and randomly assigned (1:1) to each group. The control regimen (CS chemotherapy) is recommended as the standard first-line regimen for advanced adenocarcinoma of the stomach or gastroesophageal junction in japan.

Timeline

Start
2009-10
Primary completion
2012-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Nimotuzumab Monoclonal antibody 200 mg
Background Cisplatin Other / unclassified 30 mg/m2 Intravenous
Background S-1 Small molecule 40 mg/m2

Indications