Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05484908

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

Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2024-11-29

60

Participants Needed

1

Research Sites

124 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 for more than 0.5 year)
  • Clinical diagnosis of hepatocellular carcinoma and treatment with immune checkpoint inhibitors; last immune checkpoint inhibitors treatment less than three months prior to inclusion
  • Hepatitis B virus DNA level less than 2000 IU/mL
  • Serum aspartate aminotransferase or alanine aminotransferase greater than 20 times the upper limit of normal
  • Serum total bilirubin greater than 10 times the upper limit of normal
  • Prothrombin time international ratio greater than 1.5
  • Platelet count greater than 50 x 10^9/L
  • No intrahepatic bile duct dilation due to tumor progression
Not Eligible

You will not qualify if you...

  • Any other active liver diseases
  • Any other malignancy
  • Pregnancy or lactation
  • Human immunodeficiency virus infection or congenital immune deficiency diseases
  • Severe diabetes, autoimmune diseases, unstable infarction from cardio-cerebrovascular events, other major organ dysfunctions, or organ transplantation
  • Active bleeding, disseminated intravascular coagulation, thrombosis, or thrombotic disease
  • Received artificial liver support system treatment within one week before inclusion
  • Unable to attend follow-up visits
  • Investigator considers participation inappropriate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510630

Actively Recruiting

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Research Team

W

Wenxiong Xu, Doctor

CONTACT

L

Liang Peng, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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