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

NCT ID: NCT07310069

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gallbladder Cancer Unresectable

Keywords

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gallbladder cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Wei Gong

MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Gong

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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Xinhua hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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XHEC-C-2025-111-4

Identifier Type: -

Identifier Source: org_study_id