NCT07506057

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

An Open-label, Single-arm Phase II Clinical Study of 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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Xiujuan Qu · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urothelial Carcinoma
• Biliary Tract Cancer
• HER2

Interventions

Type	Name	Description
BIOLOGICAL	Trastuzumab+Serplulimab	Patients will receive treatment with trastuzumab combined with serplulimab and chemotherapy. The treatment regimen is as follows: Trastuzumab: 6 mg/kg intravenously (IV) on day 1 of each 3-week cycle, with an initial loading dose of 8 mg/kg. Serplulimab: 4.5 mg/kg IV on day 1 of each 3-week cycle.

Timeline

• Start date: 2025-07-15
• Primary completion: 2027-07-01
• Completion: 2029-07-01
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: China