drugset / Trial / NCT03588533

Herzuma-capecitabine/Cisplatin for Gastric Cancer

NCT03588533 ↗

Phase 2 Unknown 50 enrolled Sung Yong Oh Celltrion · collab
NaSingle-groupOpen-labelTreatment

Summary

Stomach cancer is the fifth largest cancer in the world. Despite many combinations of studies, metastatic stomach cancer shows a median survival period of 10 to 12 months. According to a report in Korea in 2010, 17 % of cancer patients had over-expression of human epidemiology growth factor receptor 2 (HER-2). And Using of Trastuzumab reported better results.Herzuma® is the Trastuzumab biosimilar (Biosimilar) cloned antibody. In this study, the investigators want to prospectively analyze the effects and side effects of Herzuma® in gastric or gastroesophageal adenocarcinoma.

Timeline

Start
2018-06-10
Primary completion
2019-08-31
Completion
2021-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Monoclonal antibody 6 mg/kg —
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Cisplatin Other / unclassified 60 mg/m2 Intravenous
Background Cisplatin Other / unclassified 100 mg/m2 Intravenous