RecruitingNot ApplicableNCT05484908

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

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


Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Enrollment

60 participants

Start Date

Aug 12, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an artificial liver support system (ALSS) — a machine that temporarily helps a damaged liver filter waste from the blood — for people with liver cancer (HCC) who develop serious liver damage as a side effect of immunotherapy (checkpoint inhibitor drugs). This complication is called immune checkpoint inhibitor-induced liver failure. **You may be eligible if...** - You are between 18 and 65 years old - You have liver cancer (HCC) and also have chronic hepatitis B infection - You have received immunotherapy (checkpoint inhibitor drugs) within the past 3 months - You have developed severe liver damage as a result (very high liver enzymes and bilirubin levels) - Your platelet count and other key labs meet the required thresholds **You may NOT be eligible if...** - You have another active liver disease or another type of cancer - You are pregnant or breastfeeding - You have HIV or severe autoimmune disease - You have active uncontrolled bleeding or blood clotting problems - You received artificial liver support within the past week Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDPMAS+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.

OTHERPE

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.

OTHERComprehensive internal medical treatment

Patients will receive comprehensive internal medical treatment.


Locations(1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT05484908


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