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Recruiting NCT05484908

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

No phase Interventional Immune-Mediated Hepatitis Liver Failure Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DPMAS+LPE, PE, Comprehensive internal medical treatment.
Who it may be relevant to
Registry conditions: Immune-Mediated Hepatitis, Liver Failure, Hepatocellular Carcinoma. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other 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.
  • Other 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.
  • Other Comprehensive internal medical treatment
    Patients will receive comprehensive internal medical treatment.

Primary outcome measures

  • Mortality rate [Time frame: 12 weeks]
Secondary outcome measures (1)
  • Model for end-stage liver disease (MELD) score variation [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Third Affiliated Hospital of Sun Yat-sen University — Guangzhou

Publications

  • 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

Identifiers

NCT: NCT05484908 · XWX4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗