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ENROLLING BY INVITATION
NCT07310069
PHASE2

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

Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase II, Single-Arm, Multicenter Study of Gemcitabine and Nab-Paclitaxel in Combination With Iparomlimab and Tuvorilimab in Patients With Advanced Gallbladder Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2025-05-01

Completion Date

2027-12-30

Last Updated

2025-12-30

Healthy Volunteers

No

Interventions

DRUG

Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili

Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili

Locations (1)

Xinhua hospital

Shanghai, Shanghai Municipality, China