Study of Artificial Liver Support System Treatment for Liver Failure Caused by Immune Checkpoint Inhibitors in Patients With Hepatocellular Carcinoma
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2024-11-29
60
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the use of an artificial liver support system ALSS to treat liver failure caused by immune checkpoint inhibitors in patients with hepatocellular carcinoma HCC. This condition arises in some patients receiving immune checkpoint inhibitors, a common treatment for advanced liver cancer, and can lead to severe liver failure requiring urgent treatment. The study aims to evaluate the safety and effectiveness of ALSS treatment to manage this serious liver complication.
Participants are randomly assigned to one of two groups one group receives a combination of double plasma molecular adsorption system DPMAS and low volume plasma exchange LPE along with standard internal medical treatment, while the other group receives traditional plasma exchange PE with comprehensive internal medical treatment. Both treatments are given three times over two weeks, with specific volumes of plasma exchanged or adsorbed depending on the method used.
During the 12-week study, researchers will monitor participants symptoms, laboratory test results, adverse events, and mortality rates. The main outcome measured is the mortality rate at 12 weeks, with additional assessment of liver function using the Model for End-Stage Liver Disease MELD score. This thorough follow-up includes regular clinical evaluations and laboratory tests to assess treatment impact and safety throughout the study period.
CONDITIONS
Brief Title
Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC
Research Team
W
Wenxiong Xu, Doctor
L
Liang Peng, Doctor
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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 within the last three months
Hepatitis B virus DNA level less than 2000 IU/mL
Serum aspartate aminotransferase/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
Platelets greater than 50 x 10^9/L
No intrahepatic bile duct dilation caused by tumor progression
You will not qualify if you...
Presence of other active liver diseases
Diagnosis of other malignancies
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 history of transplantation
Active bleeding, disseminated intravascular coagulation, thrombosis, or thrombotic disease
Received artificial liver support system treatment within one week before inclusion
Inability to follow up
Considered inappropriate for the study by the investigator
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 times in 2 weeks
Participants receive artificial liver support system treatment, either double plasma molecular adsorption system with sequential low-dose plasma exchange or plasma exchange alone, along with comprehensive internal medical treatment.
3 treatment visits over 2 weeks
Follow-up
Duration - Up to 12 weeks
Participants are monitored for symptoms, signs, laboratory test results, adverse events, and mortality up to 12 weeks after treatment begins.
Regular assessments during 12 weeks
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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Published Research Related To This Trial
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.