Treatment for liver failure caused by immune checkpoint inhibitors in liver cancer patients

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

This study is testing a new artificial liver support system to see if it can help liver cancer patients with liver failure caused by certain cancer treatments feel better compared to standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05484908 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of an artificial liver support system (ALSS) for treating liver failure induced by immune checkpoint inhibitors in patients with hepatocellular carcinoma (HCC). It aims to compare two treatment approaches: a combination of double plasma molecular adsorption system (DPMAS) with sequential low-dose plasma exchange (LPE) against traditional plasma exchange (PE) alongside comprehensive internal medical treatment. The study will enroll 60 patients, who will be randomly assigned to either the trial or control group, with outcomes assessed over a 12-week period. Key metrics include symptoms, laboratory test results, adverse events, and mortality rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with chronic hepatitis B and hepatocellular carcinoma who have recently received immune checkpoint inhibitors.

Not a fit: Patients with other active liver diseases, malignancies, or severe comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from liver failure due to immune checkpoint inhibitors.

How similar studies have performed: While the use of artificial liver support systems has been explored, this specific approach for immune checkpoint inhibitors-induced liver failure is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Guangzhou, Guangdong

• Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Wenxiong Xu, Doctor — Third Affiliated Hospital, Sun Yat-Sen University
• Study coordinator: Wenxiong Xu, Doctor

Conditions Immune-Mediated Hepatitis; Liver Failure; Hepatocellular Carcinoma