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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: xuwenx@mail.sysu.edu.cn
• Phone: +8613760783281

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.