Status: Recruiting
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
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.
Participants needed: 20
Trial details
Phase: Phase 2Age: 18-85Biological sex: AllType: InterventionalSponsor: Xiujuan QuUpdated: Apr 1, 2026Locations: 1
Eligibility criteria
Age 18 to 75 years, male or female. [+11]
Known HER2-negative or HER2-low expression. [+11]