Clinical Trial

Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer

Recruiting Phase 2
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Summary
This phase II study evaluates the efficacy and safety of Trastuzumab Rezetecan in combination with Adebrelimab and Lenvatinib as first-line therapy for patients with locally advanced or metastatic HER2-positive or HER2-low biliary tract cancer. The primary objective is the objective response rate (ORR). Key secondary objectives include efficacy endpoints-progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DoR)-and safety assessments comprising adverse events (AEs), serious adverse events (SAEs), vital signs, and laboratory findings.
Trial Details
NCT Number NCT07670273
Lead Sponsor Peking Union Medical College Hospital
Conditions Biliary Tract Neoplasms Immunotherapy
Enrollment 70 participants
Start Date 2026-04-29
Primary Completion 2027-04-29 (estimated)
Study Completion 2028-04-29 (estimated)
Updated on ClinicalTrials.gov 2026-06-26