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Идёт набор NCT07239245

Study to Evaluate the Efficacy and Safety of Neo-Adjuvant TACE and Atezolizumab Plus Bevacizumab Therapy for High-Risk Recurrent Hepatocellular Carcinamo

Фаза II С лечением Resectable Hepatocellular Carcinoma With High Risk of Recurrence

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: Atezolizumab, Bevacizumab, Transarterial chemoembolization (TACE).
Кому может быть актуально
Состояния в реестре: Resectable Hepatocellular Carcinoma With High Risk of Recurrence. Базовые параметры: 18 лет — 75 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
Китай
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

Efficacy and Safety of Transarterial Chemoembolization (TACE) Combined With Atezolizumab Plus Bevacizumab in Neoadjuvant Therapy for Patients With Hepatocellular Carcinoma: an Open-label, Single-arm, Multicenter, Prospective, Phase II Clinical Study

Обзор

This is an open-label, single-arm, multicenter, prospective, phase II clinical study to evaluate the efficacy and safety of TACE combined with Atezolizumab and Bevacizumab as neoadjuvant treatment in Hepatocellular Carcinoma.

Вмешательства

  • Препарат Atezolizumab
    Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
  • Препарат Bevacizumab
    Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.
  • Процедура Transarterial chemoembolization (TACE)
    TACE will be performed by clinical demand.

Первичные конечные точки

  • Pathologic Complete Response (pCR) Rate [Срок оценки: At the time of surgery]
Вторичные конечные точки (5)
  • Major Pathologic Response (MPR) Rate [Срок оценки: At the time of surgery]
  • Relapse-Free Survival (RFS) [Срок оценки: Surgery to the first documented recurrence of disease (up to approximately 2 years)]
  • Event-Free Survival (EFS) [Срок оценки: Enrollment up to approximately 2 years]
  • Overall Survival (OS) [Срок оценки: Enrollment to death from any cause (up to approximately 5 years)]
  • Treatment-related and -unrelated toxicities (AEs, SAEs) according to NCI CTCAE v5.0 [Срок оценки: From the start of treatment to 30 days after surgery]

Критерии участия

Критерии включения

  • Signed Informed Consent Form available
  • Patients ≥ 18 years and ≤75years of age at time of signing Informed Consent Form
  • Diagnosis of HCC confirmed by histology
  • Initially resectable with high-risk recurrence factors. High-risk features for resected patients include tumor size >5 cm, tumor number >3, vascular invasion (microvascular invasion or macrovascular invasion - Vp1/Vp2 - of the portal vein) and poor tumor differentiation (defined as Grade 3 or 4).

Up to three tumors, with largest tumor >5 cm regardless of vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) or poor tumor differentiation (Grade 3 or 4) Four or more tumors, with largest tumor ≤5 cm regardless of vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) or poor tumor differentiation (Grade 3 or 4) Up to three tumors, with largest tumor ≤5 cm with vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) and/or poor tumor differentiation (Grade 3 or 4)

  • Measurable disease (at least one target lesion) according to RECIST v1.1 as determined by the investigator
  • Child-Pugh A
  • ECOG PS 0～1
  • No prior locoregional or systemic treatment for HCC
  • Negative HIV test at screening

Критерии исключения

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma, recurrent HCC and diffuse HCC
  • Clinically diagnosed hepatic encephalopathy in the last 6 months
  • Autoimmune hepatitis (requiring liver puncture)
  • History of organ transplantation
  • Clinical symptoms of pleural effusion, ascites, pericardial effusion, and any history of kidney disease or nephrotic syndrome
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
  • A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
  • Known severe allergic reaction to contrast (e.g., anaphylaxis).
  • Pregnancy or lactating women.
  • Inability to provide informed consent.

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 · 4 центра
  • Cancer Hospital Chinese Academy of Medical Science — Пекин
  • Henan Cancer Hospital — Чжэнчжоу
  • The First Hospital of China Medical University — Шэньян
  • Shanxi Cancer Hospital — Taiyuan

Идентификаторы

NCT: NCT07239245 · NCC5353

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗