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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili
Xinhua hospital
Shanghai, Shanghai Municipality, China
ORR
The objective response rate (ORR) of this quadruplet regimen as first-line therapy
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Surgical Conversion Rate
Proportion of patients who achieve successful conversion to radical resection (R0/R1) after systemic therapy.
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Downstaging Rate
Proportion of patients whose clinical stage is reduced after conversion therapy.
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Pathologic Response Rate
Proportion of patients with pathologic downstaging or major pathologic response in resected specimens
Time frame: At the end of Cycle 6 (each cycle is 21 days)
R0 Resection Rate
Proportion of patients who undergo R0 resection among those who receive surgery.
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Disease Control Rate (DCR)
Proportion of patients with CR, PR, or stable disease (SD) lasting ≥4 weeks.
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Recurrence-Free Survival (RFS)
Proportion of patients without recurrence at 2 years after resection.
Time frame: up to 2 years
Overall Survival (OS)
Time from enrollment to death from any cause.
Time frame: through study completion,up to 3 years
Adverse Events (AEs) / Serious AEs (SAEs)
Incidence and severity of AEs and SAEs graded by CTCAE v5.0.
Time frame: through study completion, up to 30 days
Surgical Safety
Incidence of surgery-related complications (e.g., infection, bleeding, organ dysfunction)
Time frame: Perioperative
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