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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• ORR [Срок оценки: At the end of Cycle 6 (each cycle is 21 days)]
• Surgical Conversion Rate [Срок оценки: At the end of Cycle 6 (each cycle is 21 days)]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xinhua hospital — Шанхай

Идентификаторы

NCT: NCT07310069 · XHEC-C-2025-111-4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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