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Gemcitabine and Nab-Paclitaxel Combined With Iparomlimab and Tuvorilimab for Advanced Gallbladder Cancer | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONPHASE2

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

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

NCT07310069•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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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

Locations (1)

Xinhua hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

May 1, 2025

Primary Completion Date

May 1, 2027

Completion Date

December 30, 2027

Last Updated

December 30, 2025

Enrollment

ESTIMATED participants

Conditions

Gallbladder Cancer Unresectable

Interventions

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

DRUG

Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients with Locally Advanced or Metastatic Gallbladder Cancer

NCT06591650

Gallbladder Cancer Unresectable

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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