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

Sponsor
Xiujuan Qu
Study ID
NCT07506057
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab+Serplulimab — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Jul 15, 2025
Status verified
Feb 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    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. Chemotherapy for Biliary Tract Cancer: Selected by the investigator based on the participant's condition, including but not limited to the FOLFOX regimen: oxaliplatin 85 mg/m² IV over 2 hours on day 1, leucovorin 400 mg/m² IV over 2 hours on day 1, fluorouracil 400 mg/m² IV bolus on day 1, followed by fluorouracil 2400-3000 mg/m² continuous IV infusion over 46 hours on day 1, repeated every 2 weeks. Chemotherapy for Urothelial Carcinoma: Selected by the investigator based on the participant's condition, including but not limited to paclitaxel 135-175 mg/m² IV on day 1, repeated every 3 weeks.

Primary Outcome Measure

objective response rate (ORR) [ Time Frame: From the first dose of study treatment until disease progression, intolerance, or start of new anti-cancer therapy, assessed every 6 weeks for the first 12 months and every 12 weeks thereafter, up to approximately 24 months. ]

Central Contacts

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