Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
Sponsor: RemeGen Co., Ltd.
Summary
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma with HER2-high Expression.
Official title: A Randomized Controlled Phase III Study to Evaluate the Combination of Disitamab Vedotin, Trastuzumab, and Tislelizumab Versus Chemotherapy (CAPOX) Combined With Trastuzumab With or Without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma With HER2-high Expression
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
555
Start Date
2026-01-01
Completion Date
2030-12-31
Last Updated
2026-01-21
Healthy Volunteers
No
Conditions
Interventions
Disitamab Vedotin
Disitamab Vedotin: 2.5 mg/kg, IV, D1, Q2W;
Tislelizumab
Tislelizumab: 200 mg, IV, D1, Q3W
CAPOX (oxaliplatin/capecitabine)
Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W;
Trastuzumab
Trastuzumab: Initial dose of 8mg/kg, followed by 6 mg/kg, IV, D1, Q3W;
Pembrolizumab
Pembrolizumab: 200mg, IV, D1, Q3W
Locations (1)
Beijing Cancer Hospital
Beijing, BJ-Beijing, China