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Enrolling by Invitation

NCT Number: NCT07310069

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

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.

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Key information

Conditions

Gallbladder Cancer Unresectable Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Gallbladder Diseases Gallbladder Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Xinhua hospital

Shanghai, Shanghai Municipality, 200092, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. ORR

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

    The objective response rate (ORR) of this quadruplet regimen as first-line therapy

  2. Surgical Conversion Rate

    Time frame: 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.

Secondary outcomes

  1. Downstaging Rate

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

    Proportion of patients whose clinical stage is reduced after conversion therapy.

  2. Pathologic Response Rate

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

    Proportion of patients with pathologic downstaging or major pathologic response in resected specimens

  3. R0 Resection Rate

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

    Proportion of patients who undergo R0 resection among those who receive surgery.

  4. Disease Control Rate (DCR)

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

    Proportion of patients with CR, PR, or stable disease (SD) lasting ≥4 weeks.

  5. Recurrence-Free Survival (RFS)

    Time frame: up to 2 years

    Proportion of patients without recurrence at 2 years after resection.

  6. Overall Survival (OS)

    Time frame: through study completion,up to 3 years

    Time from enrollment to death from any cause.

  7. Adverse Events (AEs) / Serious AEs (SAEs)

    Time frame: through study completion, up to 30 days

    Incidence and severity of AEs and SAEs graded by CTCAE v5.0.

  8. Surgical Safety

    Time frame: Perioperative

    Incidence of surgery-related complications (e.g., infection, bleeding, organ dysfunction)

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study 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

Acronym: TRANSFORM-GBC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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