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Идёт набор NCT06323382

Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma

— Наблюдательное Advanced Hepatocellular Carcinoma Anti-PD1/PDL1 Antibody Bevacizumab

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: Locoregional therapy, Bevacizumab, Atezolizumab, Tislelizumab.
Кому может быть актуально
Состояния в реестре: Advanced Hepatocellular Carcinoma, Anti-PD1/PDL1 Antibody, Bevacizumab. Базовые параметры: 18 лет — 80 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
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Официальное название

Efficacy of Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma: a Multicenter, Observational, Real-world Study

Обзор

Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD1) and PDL1 inhibitor, was effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in patients with advanced hepatocellular carcinoma who can not receive radical therapy.

Подробное описание

This study is a multicenter, observational real-world study to explore the efficacy, safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in advanced hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with Bevacizumab and PD-1/L1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing locoregional therapy combined Bevacizumab and PD-1/L1 inhibitor as standard of care in hopes of answering key clinical questions.

Вмешательства

  • Процедура Locoregional therapy
    TACE procedure The decision to utilize transarterial artery chemoembolization (TACE) was performed through the tumor-feeding artery. The embolization emulsion was a mixture of Epirubicin 30-60 mg, Lobaplatin 30-50 mg, and Lipiodol 10-30 ml, and it was infused into tumor-feeding arteries via a 2.7/2.8 Fr micro-catheter. HAIC procedure Hepatic arterial infusion chemotherapy (HAIC) procedure was performed with FOLFOX regimen: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1400 mg/m2 leucovori
  • Препарат Bevacizumab
    15mg/kg or 7.5mg/kg intravenously every 3 weeks
  • Препарат Atezolizumab
    1200mg intravenously every 3 weeks
  • Препарат Tislelizumab
    200mg intravenously every 3 weeks
  • Препарат Toripalimab
    220mg intravenously every 3 weeks
  • Препарат Sintilimab
    200mg intravenously every 3 weeks
  • Препарат Camrelizumab
    200mg intravenously every 3 weeks

Первичные конечные точки

  • Progression-Free-Survival (PFS) [Срок оценки: 12 months]
Вторичные конечные точки (3)
  • Overall survival (OS) [Срок оценки: 24 months]
  • Objective response rate (ORR) [Срок оценки: 12 months]
  • Adverse events [Срок оценки: 24 months]

Критерии участия

Критерии включения

  • HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;
  • age between 18 and 75 years;
  • Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage).
  • Locoregional therapy include TACE or HAIC, locoregional combined with Bevacizumab and PD1/L1 inhibitor as firstline therapy; non-firstline therapy (previous use of any systemic therapy but intolerant or drug resistant).
  • Child-Pugh class A or B;
  • Eastern Cooperative Group performance status (ECOG) score of 0-2;
  • Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
  • Prothrombin time ≤18s or international normalized ratio < 1.7.
  • Ability to understand the protocol and to agree to and sign a written informed consent document.

Критерии исключения

  • Cholangiocellular carcinoma (ICC).
  • Patients without image information should be excluded;
  • The survival or patients less than 3 months.
  • Serious medical comorbidities.
  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy.
  • Known history of HIV.
  • History of organ allograft.
  • Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Evidence of bleeding diathesis.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Chinese PLA hospital — Пекин

Идентификаторы

NCT: NCT06323382 · Liver Project 6

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗