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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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);

• 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;

• 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.

Locations
Other Locations
China
Third Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Wenxiong Xu, Doctor
xuwenx@mail.sysu.edu.cn
+8613760783281
Backup
Liang Peng, Doctor
pliang@mail.sysu.edu.cn
+8613533978874
Time Frame
Start Date: 2022-08-12
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 60
Treatments
Experimental: DPMAS+LPE group
30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment.
Active_comparator: PE group
30 patients receive treatment of PE and comprehensive internal medical treatment.
Related Therapeutic Areas
Sponsors
Leads: Third Affiliated Hospital, Sun Yat-Sen University

This content was sourced from clinicaltrials.gov