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

StatusRecruiting
PhasePhase 3
Started2025-08-18
View on ClinicalTrials.gov ↗

Amendment history

2026-02-10
Study Status, Eligibility v2
Eligibility criteria-25 characters
[...] on adenocarcinoma. ECOG performance status score of 0 to 1. Body weight ≥ 35 kg. Life expectancy ≥12 weeks. Must have at least one measurable [...] ive tuberculosis over 1 year without appropriate treatment. 11、14. History of immunodeficiency, including positive HIV test; active hepatitis B or hepatitis C. 12、Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation. 13、Severe cardiovascular or cerebrovascular diseases. Clinically significant14、Active bleeding symptoms(CTCAE orGrade significant≥ bleeding tendency within 3 months before randomiz [...] [...]
2025-09-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-08→confirmed 2025-08-18
Study sitesdetails revised at 2 of 2 sites
2025-08-11
Original filing
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.
Trial Details
NCT Number NCT07118527
Lead Sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions Patients With Unresectable Locally Advanced or Metastatic Untreated Gastric or Gastroesophageal Junction Adenocarcinoma
Enrollment 600 participants
Start Date 2025-08-18
Primary Completion 2030-10 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2026-02-11