drugset / Trial / NCT02725424
Optimizing the Strategy for Preoperative Chemotherapy in Locally Advanced Gastric/Gastroesophageal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, phase II, open-label study. The purpose of this study is to determine the optimal treatment for patients with locally advanced Gastric/Gastroesophageal Cancer according to their HER-2 expression status. The primary endpoint of this study: major pathology response rate the second endpoints of this study: pathology complete response rate R0 resection rate Progression-free survival ( PFS) Disease -free survival (DFS) Overall survival(OS) Objective response rate(ORR) Adverse event(AE)
Timeline
- Start
- 2015-08
- Primary completion
- 2018-12
- Completion
- 2019-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | S-1 | Small molecule | 80 mg | Oral |
| Background | S-1 | Small molecule | 100 mg | Oral |
| Background | S-1 | Small molecule | 120 mg | Oral |