Clinical Trial

Trastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy

Study acronym: SHIELD
Recruiting Phase 2
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Summary
his single-center phase II clinical study enrolls patients with unresectable locally advanced or metastatic HER2-overexpressing biliary tract cancer or urothelial carcinoma who have failed standard treatment. Participants receive trastuzumab in combination with serplulimab and chemotherapy. The study aims to evaluate the efficacy and safety of this regimen in this patient population. The primary endpoint is objective response rate (ORR). Secondary endpoints include overall survival (OS), progression-free survival (PFS), and safety.
Trial Details
NCT Number NCT07506057
Lead Sponsor Xiujuan Qu
Conditions Urothelial Carcinoma, Biliary Tract Cancer, HER2
Enrollment 20 participants
Start Date 2025-07-15
Primary Completion 2027-07 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-01