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Gemcitabine and Nab-Paclitaxel Combined With Iparomlimab and Tuvorilimab for Advanced Gallbladder Cancer

Study acronym: TRANSFORM-GBC
StatusEnrolling by Invitation
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This is a single-arm, multicenter, Phase II clinical trial evaluating the efficacy and safety of Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorilimab (a dual anti-PD-1/CTLA-4 bispecific antibody) in patients with advanced unresectable gallbladder cancer. The study aims to assess the surgical conversion rate and objective response rate (ORR) as primary endpoints. Secondary endpoints include R0 resection rate, disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profiles. A total of 44 participants will be enrolled across three centers in China. The study is scheduled to run from May 2025 to April 2027.
Trial Details
NCT Number NCT07310069
Lead Sponsor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions
(from sponsor)		 Gallbladder Cancer Unresectable
Related terms Gallbladder Neoplasms
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov