NCT07118527

A Phase III Study of SHR-A1811 in Combination With Chemotherapy and Adebrelimab in Previously Untreated Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase III, Randomized, Multicenter, Open-label Study to Evaluate SHR-A1811 in Combination With Chemotherapy and Adebrelimab Versus Trastuzumab in Combination With Chemotherapy and Pembrolizumab in Patients With Previously Untreated, Unresectable, Locally Advanced or Metastatic, Gastric or Gastroesophageal Junction Adenocarcinoma Expressing

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of SHR-A1811 combined with chemotherapy and immune checkpoint inhibitor versus standard first-line therapy in gastric or gastroesophageal junction adenocarcinoma.

Conditions

• Patients With Unresectable Locally Advanced or Metastatic Untreated Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	SHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil Injection	SHR-A1811: intravenous infusion; Adebrelimab Injection: intravenous infusion; Capecitabine Tablets: oral administration Fluorouracil Injection: intravenous infusion
DRUG	Trastuzumab + Pembrolizumab + CAPOX( Capecitabine Tablets + Oxaliplatin) or FP (Fluorouracil Injection+Cisplatin)	Trastuzumab : intravenous infusion; Pembrolizumab: intravenous infusion; Capecitabine Tablets: oral administration; Oxaliplatin: intravenous infusion; Fluorouracil Injection: intravenous infusion; Cisplatin: intravenous infusion;

Timeline

• Start date: 2025-08-18
• Primary completion: 2030-10-01
• Completion: 2030-10-01
• First posted: 2025-08-12
• Last updated: 2026-02-11

Locations

2 sites across 1 country: China