NCT02370849

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

Cisplatin and S-1 With or Without Nimotuzumab for Patients With Previously Untreated Advanced Gastric Adenocarcinoma: a Single-center, Randomised, Open-label, Parallel-group, Controlled Phase 2 Clinical Trial

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

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.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	nimotuzumab	nimotuzumab 200mg infusion on day 1,8,15 every 3 weeks
DRUG	cisplatin	cisplatin: 30 mg/m2 iv. infusion on day 1, 2 every 3 weeks
DRUG	S-1	S-1: 40 mg/m2 bid , 2 weeks on, 1 week off ；

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-02-01
• Completion: 2015-02-01
• First posted: 2015-02-25
• Last updated: 2015-02-25

Locations

1 site across 1 country: China