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.
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (assessed by the BIRC) — 24 months
Progression-free survival (PFS) is defined as the time from the date of randomization to disease progression per RECIST 1.1 as assessed by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Cancer Hospital | Beijing | BJ-Beijing | Recruiting |
More RemeGen Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07315750 on ClinicalTrials.gov ↗ ← All trials in China