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Clinical Trials in China / NCT07310069
Enrolling by invitation Phase 2

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

NCT07310069 · tracked via the Priya Life Science China tracker
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Phase
Phase 2
Started
2025-05-01
Last updated
2025-12-30

Condition(s) studied

Gallbladder Cancer Unresectable

Investigational drug(s) / intervention(s)

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

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • ORR — At the end of Cycle 6 (each cycle is 21 days)
    The objective response rate (ORR) of this quadruplet regimen as first-line therapy
  • Surgical Conversion Rate — At the end of Cycle 6 (each cycle is 21 days)
    Proportion of patients who achieve successful conversion to radical resection (R0/R1) after systemic therapy.

Trial sites (1)

FacilityCityRegionStatus
Xinhua hospital Shanghai Shanghai Municipality

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Other trials for the same condition

Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07310069 on ClinicalTrials.gov ↗ ← All trials in China