Actively Recruiting
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
On this page
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
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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