NCT05484908

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Immune-Mediated Hepatitis
• Liver Failure
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
OTHER	DPMAS+LPE	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.
OTHER	PE	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.
OTHER	Comprehensive internal medical treatment	Patients will receive comprehensive internal medical treatment.

Timeline

• Start date: 2022-08-12
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-08-02
• Last updated: 2024-11-29

Locations

1 site across 1 country: China