Efficacy and safety of artificial liver support system treatment for immune checkpoint inhibitors related liver failure in patients with hepatocellular carcinoma: a randomized controlled clinical trial

Abstract Background: It is well-established that immune checkpoint inhibitors-induced immune-mediated hepatitis (ICIs-IMH) in patients with hepatocellular carcinoma (HCC) increases susceptibility to liver failure (LF). Given mounting evidence that artificial liver support system (ALSS) treatment can effectively relieve both IMH and LF, a single-center, non-blinded, randomized controlled clinical trial will be conducted to investigate the efficacy and safety of ALSS for HCC patients with ICIs-LF. Methods and analysis: Sixty participants who meet the eligibility criteria will be enrolled in this trial and randomized to one of two arms at a 1:1 ratio. In addition to comprehensive pharmacological treatment, patients in the trial group will receive treatment with double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (LPE) three times, while patients in the control group will undergo PE three times. Patient evaluations, including symptoms and laboratory tests, will be performed at baseline, before and after the three times of ALSS treatment, and 2, 4, 8, and 12 weeks after enrollment. The primary outcome is the mortality rate at 12-week follow-up. The secondary outcomes include the change in the Model for end-stage liver disease (MELD) score after ALSS treatment and the incidence of adverse events (AEs). Discussion: ICIs-LF in patients with HCC have a high mortality rate and lacks effective treatment. Our study can evaluate the efficacy and safety of ALSS for this patient population, and compare the two modes of ALSS (DPMAS+LPE vs. DPMAS). Trial registration: ClinicalTrials.gov ID: NCT05484908 (Release Date: July 30, 2022).