drugset / Trial / NCT02370849
Cisplatin and S-1 With or Without Nimotuzumab in Untreated Advanced Gastric Adenocarcinoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nimotuzumab | Monoclonal antibody | 200 mg | — |
| Background | Cisplatin | Other / unclassified | 30 mg/m2 | Intravenous |
| Background | S-1 | Small molecule | 40 mg/m2 | — |