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

NCT05484908 | Recruiting

• 1 other identifier: XWX4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immune-Mediated Hepatitis; Liver Failure; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  Mortality rate at 12-week follow-up.

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Study Arms (2)

DPMAS+LPE group

EXPERIMENTAL

30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment.

Other: DPMAS+LPE; Other: Comprehensive internal medical treatment

PE group

ACTIVE COMPARATOR

30 patients receive treatment of PE and comprehensive internal medical treatment.

Other: PE; Other: Comprehensive internal medical treatment

Interventions

DPMAS+LPE OTHER

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.

DPMAS+LPE group

PE OTHER

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.

PE group

Comprehensive internal medical treatment OTHER

Patients will receive comprehensive internal medical treatment.

DPMAS+LPE group; PE group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 65 years old;
• Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \> 0.5 year);
• The level of hepatitis b virus DNA \< 2000 IU/mL；
• Serum aspartate aminotransferase/alanine aminotransferase \> 20 times upper limit of normal；serum total bilirubin\>10 times upper limit of normal；
• Prothrombin time international ratio \> 1.5;
• Platelets \> 50\*10 E9/L;
• Without intrahepatic bile duct dilation due to tumor progression.

You may not qualify if:

• Other active liver diseases;
• Other malignancy;
• Pregnancy or lactation;
• Human immunodeficiency virus infection or congenital immune deficiency diseases;
• Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events; other important organ dysfunctions or transplantation;
• Active bleeding, disseminated intravascular coagulation, thrombosis, or thrombotic disease;
• Patients can not follow-up;
• Investigator considering inappropriate

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (1)

• Luo Q, Zhang Y, Li Z, Chen J, Deng Z, Lai J, Chen X, Xie C, Peng L, Liu Y, Xu W. Efficacy and safety of artificial liver support system treatment for immune checkpoint inhibitors related liver failure in patients with hepatocellular carcinoma: Protocol for a randomized controlled clinical trial. Heliyon. 2024 Oct 9;10(20):e39095. doi: 10.1016/j.heliyon.2024.e39095. eCollection 2024 Oct 30.

  PMID: 39640621 DERIVED

MeSH Terms

Conditions

Liver Failure; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Wenxiong Xu, Doctor

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenxiong Xu, Doctor

CONTACT

+8613760783281; xuwenx@mail.sysu.edu.cn

Liang Peng, Doctor

CONTACT

+8613533978874; pliang@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: July 30, 2022
• First Posted: August 2, 2022
• Study Start: August 12, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Proposals should be directed to xuwenx@mail.sysu.edu.cn. To gain access, data requestors will need to sign a data access agreement

Locations

CN (1)