Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili | Experimental | Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili | Drug | Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | The objective response rate (ORR) of this quadruplet regimen as first-line therapy | 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. | At the end of Cycle 6 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Downstaging Rate | Proportion of patients whose clinical stage is reduced after conversion therapy. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wei Gong | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua hospital | Shanghai | Shanghai Municipality | 200092 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorilimab (a dual anti-PD-1/CTLA-4 bispecific antibody)
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | up to 2 years |
| Overall Survival (OS) | Time from enrollment to death from any cause. | 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. | through study completion, up to 30 days |
| Surgical Safety | Incidence of surgery-related complications (e.g., infection, bleeding, organ dysfunction) | Perioperative |
| ID | Term |
|---|---|
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
Not provided
Not provided
Not provided