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Enrolling by invitation NCT07310069

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

Phase II Interventional Gallbladder Cancer Unresectable

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili.
Who it may be relevant to
Registry conditions: Gallbladder Cancer Unresectable. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • ORR [Time frame: At the end of Cycle 6 (each cycle is 21 days)]
  • Surgical Conversion Rate [Time frame: At the end of Cycle 6 (each cycle is 21 days)]
Secondary outcome measures (8)
  • Downstaging Rate [Time frame: At the end of Cycle 6 (each cycle is 21 days)]
  • Pathologic Response Rate [Time frame: At the end of Cycle 6 (each cycle is 21 days)]
  • R0 Resection Rate [Time frame: At the end of Cycle 6 (each cycle is 21 days)]
  • Disease Control Rate (DCR) [Time frame: At the end of Cycle 6 (each cycle is 21 days)]
  • Recurrence-Free Survival (RFS) [Time frame: up to 2 years]
  • Overall Survival (OS) [Time frame: through study completion,up to 3 years]
  • Adverse Events (AEs) / Serious AEs (SAEs) [Time frame: through study completion, up to 30 days]
  • Surgical Safety [Time frame: Perioperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Xinhua hospital — Shanghai

Identifiers

NCT: NCT07310069 · XHEC-C-2025-111-4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗