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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGobjective response rate (ORR)
Objective response rate (ORR) as assessed by the investigator according to RECIST version 1.1, defined as the proportion of patients achieving complete response (CR) or partial response (PR).
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.
Overall Survival (OS)
The time from randomization (or first dose) to death from any cause.
Time frame: From first dose until death, assessed every 6 weeks (Year 1) then every 12 weeks, and every 3 months during survival follow-up, up to approximately 24 months.
Progression-Free Survival (PFS)
The time from the first dose of study treatment to the first documented disease progression or death from any cause.
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
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