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

Sun Yat-sen University

Status: Enrolling

Conditions: Liver Failure; Hepatocellular Carcinoma; Immune-Mediated Hepatitis

Treatments: Other: Comprehensive internal medical treatment; Other: PE; Other: DPMAS+LPE

Study type: Interventional

Funder types: Other

Identifiers

NCT05484908

XWX4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age from 18 to 65 years old;
2. Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA > 0.5 year);
3. 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;
4. The level of hepatitis b virus DNA < 2000 IU/mL；
5. Serum aspartate aminotransferase/alanine aminotransferase > 20 times upper limit of normal；serum total bilirubin>10 times upper limit of normal；
6. Prothrombin time international ratio > 1.5;
7. Platelets > 50*10 E9/L;
8. Without intrahepatic bile duct dilation due to tumor progression.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

DPMAS+LPE group

Experimental group

Description:

30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment.

Treatment:

Other: DPMAS+LPE

Other: Comprehensive internal medical treatment

PE group

Active Comparator group

Description:

30 patients receive treatment of PE and comprehensive internal medical treatment.

Treatment:

Other: PE

Other: Comprehensive internal medical treatment