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

NCT07310069 | Enrolling By Invitation Phase 2

• 1 other identifier: XHEC-C-2025-111-4
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gallbladder Cancer Unresectable

Keywords

gallbladder cancer

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (8)

• Downstaging Rate

  At the end of Cycle 6 (each cycle is 21 days)

• Pathologic Response Rate

  At the end of Cycle 6 (each cycle is 21 days)

• R0 Resection Rate

  At the end of Cycle 6 (each cycle is 21 days)

• Disease Control Rate (DCR)

  At the end of Cycle 6 (each cycle is 21 days)

• Recurrence-Free Survival (RFS)

  up to 2 years

Study Arms (1)

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

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Age 18-75 years.
• ECOG performance status 0-2, Child-Pugh class A.
• Histologically or cytologically confirmed advanced gallbladder cancer, deemed unresectable for R0 resection.
• Adequate organ function:
• ANC ≥1.5×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥90 g/L.
• Serum creatinine ≤1.2 mg/dL or creatinine clearance ≥60 mL/min.
• Total bilirubin ≤1.5×ULN (≤3×ULN if liver metastases); AST/ALT ≤3×ULN (≤5×ULN if liver metastases).
• Life expectancy ≥3 months.
• Non-pregnant, non-lactating women and willingness to use contraception during and for 3 months after treatment.

You may not qualify if:

• Severe systemic infection or uncontrolled comorbidities (e.g., heart failure, thyroid disease, psychiatric disorders); active autoimmune disease requiring medication.
• Known allergy or intolerance to chemotherapy agents.
• Prior antitumor therapy (chemotherapy, radiotherapy, immunotherapy) within the past year, or history of other malignancies (except cured cervical carcinoma in situ or non-melanoma skin cancer).
• Pregnancy, lactation, or unwillingness to use contraception.
• Participation in another clinical trial within 30 days before the first dose.
• Unwillingness to participate or inability to provide informed consent.
• Any other condition that, in the investigator's judgment, may affect patient safety or compliance

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua hospital

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Gallbladder Neoplasms

Interventions

130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Officials

• Wei Gong

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Model Details: Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorilimab (a dual anti-PD-1/CTLA-4 bispecific antibody)

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 30, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)