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

Third Affiliated Hospital, Sun Yat-Sen University60 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Immune-Mediated Hepatitis Liver Failure Hepatocellular Carcinoma

Interventions

DPMAS+LPEOTHER

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.

PEOTHER

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.

Comprehensive internal medical treatmentOTHER

Patients will receive comprehensive internal medical treatment.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Mortality rate

Mortality rate at 12-week follow-up.

Time frame: 12 weeks

Secondary Outcomes

Model for end-stage liver disease (MELD) score variation

Variation of MELD score at 12 weeks after treatment. MELD score = 9.57 × loge(creatinine mg/dl) + 3.78 × loge(TBIL mg/dl) + 11.20 × loge(PT-INR) + 6.43.

Time frame: 12 weeks

Central Contacts

Wenxiong Xu, Doctor

CONTACT

+8613760783281 xuwenx@mail.sysu.edu.cn

Liang Peng, Doctor

CONTACT

+8613533978874 pliang@mail.sysu.edu.cn

Data from ClinicalTrials.gov

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