Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC

Официальное название

Efficacy and Safety of Artificial Liver Support System Treatment for Immune Checkpoint Inhibitors Related Liver Failure in Patients With Hepatocellular Carcinoma

Обзор

This study aims to investigate the efficacy and safety of artificial liver support system treatment for immune checkpoint inhibitors related liver failure in patients with hepatocellular carcinoma.

Подробное описание

Immune checkpoint inhibitors (ICIs) are commonly used for advanced stage of hepatocellular carcinoma (HCC) in recent years. The incident rate of Grade 4 immune checkpoint inhibitors-induced immune mediated hepatitis reaches 14.5%. Since these patients usually develop into liver failure, it is urgent to find out a more suitable therapy. Artificial liver support system (ALSS) treatment has been proved to effectively control both immune mediated hepatitis and liver failure, it may be a new therapy for immune checkpoint inhibitors-induced liver failure (ICIs-LF) in patients with HCC. Therefore, this study aims to investigate the efficacy and safety of ALSS treatment, including the classic mode of plasma exchange (PE) and new combination mode of double plasma molecular adsorption system (DPMAS) with sequential low-dose plasma exchange (LPE), for ICIs-LF in patients with HCC. Sixty patients with HCC and ICIs-LF will be enrolled in this study. The participants are randomly divided into trial group (DPMAS+LPE, and comprehensive internal medical treatment) and control group (PE and comprehensive internal medical treatment). Symptoms, signs, laboratory tests results, adverse events, mortality rates are recorded from treatment baseline to 12 weeks.

Вмешательства

• Другое DPMAS+LPE
  Patients will receive treatment of double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (LPE) for three times in two weeks. The volume of plasma adsorption in DPMAS is 5000\~6000 millilitre. The volume of fresh frozen plasma used in LPE is 1000 millilitre.
• Другое PE
  Patients will receive treatment of plasma exchange (PE) for three times in two weeks. The volume of fresh frozen plasma used in PE is 2000 millilitre.
• Другое Comprehensive internal medical treatment
  Patients will receive comprehensive internal medical treatment.

Первичные конечные точки

• Mortality rate [Срок оценки: 12 weeks]

Вторичные конечные точки (1)

• Model for end-stage liver disease (MELD) score variation [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Age from 18 to 65 years old;
• Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA > 0.5 year);
• Clinical diagnosis of hepatocellular carcinoma and receive immune checkpoint inhibitors treatment. The last treatment of immune checkpoint inhibitors is less than three months from inclusion;
• The level of hepatitis b virus DNA < 2000 IU/mL；
• Serum aspartate aminotransferase/alanine aminotransferase > 20 times upper limit of normal；serum total bilirubin>10 times upper limit of normal；
• Prothrombin time international ratio > 1.5;
• Platelets > 50\*10 E9/L;
• Without intrahepatic bile duct dilation due to tumor progression.

Критерии исключения

• Other active liver diseases;
• Other malignancy;
• Pregnancy or lactation;
• Human immunodeficiency virus infection or congenital immune deficiency diseases;
• Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events; other important organ dysfunctions or transplantation;
• Active bleeding, disseminated intravascular coagulation, thrombosis, or thrombotic disease;
• Patients received artificial liver support system treatment in one week before inclusion;
• Patients can not follow-up;
• Investigator considering inappropriate

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Third Affiliated Hospital of Sun Yat-sen University — Гуанчжоу

Публикации

• Luo Q, Zhang Y, Li Z, Chen J, Deng Z, Lai J, Chen X, Xie C, Peng L, Liu Y, Xu W. Efficacy and safety of artificial liver support system treatment for immune checkpoint inhibitors related liver failure in patients with hepatocellular carcinoma: Protocol for a randomized controlled clinical trial. Heliyon. 2024 Oct 9;10(20):e39095. doi: 10.1016/j.heliyon.2024.e39095. eCollection 2024 Oct 30. PMID 39640621

Идентификаторы

NCT: NCT05484908 · XWX4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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