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Идёт набор NCT07679061

First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE)

— Наблюдательное Unresectable Hepatocellular Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Nivolumab plus ipilimumab.
Кому может быть актуально
Состояния в реестре: Unresectable Hepatocellular Carcinoma. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Япония
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective Observational Study of First-Line Nivolumab Plus Ipilimumab in Patients With Unresectable Hepatocellular Carcinoma in Japan (J-PROMISE)

Обзор

This study looks at how a combination of two medicines, nivolumab and ipilimumab, is used to treat people with advanced liver cancer that cannot be removed by surgery. The study will follow adults receiving this treatment in routine medical care in Japan to understand how safe it is, how well it works, and how it is used in standard clinical practice.

Вмешательства

  • Комбинированный продукт Nivolumab plus ipilimumab
    According to product label

Первичные конечные точки

  • Number of participants with grade ≥3 immune-mediated liver injury (IMLI) [Срок оценки: Up to 2 years]
  • Time to onset of immune-mediated liver injury (IMLI) [Срок оценки: Up to 2 years]
  • Time to resolution of immune-mediated liver injury (IMLI) [Срок оценки: Up to 2 years]
  • Number of participants with immune-mediated liver injury (IMLI) who achieve resolution (recovered, recovering, or recovered with sequelae) [Срок оценки: Up to 2 years]
  • Treatment prescribed to participants for immune-mediated liver injury (IMLI) [Срок оценки: Up to 2 years]
  • Objective response rate (ORR) [Срок оценки: Up to 2 years]
  • Best overall response (BOR) [Срок оценки: Up to 2 years]
  • Disease control rate (DCR [Срок оценки: Up to 2 years]
  • Duration of nivolumab plus ipilimumab combination therapy [Срок оценки: Up to 2 years]
  • Number of nivolumab plus ipilimumab treatment cycles per participant [Срок оценки: Up to 2 years]
Вторичные конечные точки (12)
  • Number of participants with immune-mediated adverse events (IMAEs) [Срок оценки: Up to 2 years]
  • Time to onset of immune-mediated adverse events (IMAEs) [Срок оценки: Up to 2 years]
  • Time to resolution of immune-mediated adverse events (IMAEs) [Срок оценки: Up to 2 years]
  • Number of participants with immune-mediated adverse events (IMAEs) who achieve resolution (recovered, recovering, or recovered with sequelae) [Срок оценки: Up to 2 years]
  • Treatment prescribed to participants for immune-mediated adverse events (IMAEs) [Срок оценки: Up to 2 years]
  • Number of participants with of immune-mediated adverse events (IMAEs) leading to treatment discontinuation [Срок оценки: Up to 2 years]
  • Number of participants with treatment-related adverse events (TRAEs) [Срок оценки: Up to 2 years]
  • Time to onset of treatment-related adverse events (TRAEs) [Срок оценки: Up to 2 years]
  • Time to resolution of treatment-related adverse events (TRAEs) [Срок оценки: Up to 2 years]
  • Number of participants with treatment-related adverse events (TRAEs) who achieve resolution (recovered, recovering, or recovered with sequelae) [Срок оценки: Up to 2 years]
  • Number of participants with treatment-related adverse events (TRAEs) leading to treatment discontinuation [Срок оценки: Up to 2 years]
  • Duration of response (DOR) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

  • Participants aged ≥ 18 years at the time of consent
  • Participants with unresectable hepatocellular carcinoma (uHCC), defined as disease not eligible for curative surgical and/or locoregional therapies, or progressive disease after surgical and/or locoregional therapies
  • Child-Pugh class A (total score 5-6)
  • Participants who have not received prior systemic drug therapy for uHCC
  • Participants who relapsed more than 6 months after completion of postoperative adjuvant therapy are eligible
  • Participants who received lenvatinib in combination with transarterial chemoembolization (TACE) are eligible if the treating physician determined they were eligible for TACE; participants are excluded if TACE eligibility at the time of lenvatinib initiation is unclear
  • Participants scheduled to initiate nivolumab plus ipilimumab combination therapy between March 1, 2026 and February 28, 2027
  • Nivolumab plus ipilimumab combination therapy is defined as nivolumab 80 mg and ipilimumab 3 mg/kg administered intravenously every 3 weeks for 4 cycles, followed by nivolumab monotherapy at 240 mg every 2 weeks or 480 mg every 4 weeks
  • Participants who provide written informed consent prior to initiation of nivolumab plus ipilimumab therapy

Критерии исключения

  • Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma
  • Prior liver transplant
  • ECOG performance status ≥ 3
  • Uncontrolled comorbidities despite treatment
  • Other advanced cancers requiring systemic therapy
  • Prior immuno-oncology treatment
  • Participation in interventional clinical trials at enrollment
  • Deemed unsuitable by investigator

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Япония · 2 центра
  • Mebix. Inc — Minato-ku
  • National Cancer Center Hospital East — Chiba

Идентификаторы

NCT: NCT07679061 · CA209-1554

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗