Actively Recruiting
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2024-11-29
60
Participants Needed
1
Research Sites
N/A
Total Duration
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
Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
W
Wenxiong Xu, Doctor
L
Liang Peng, Doctor
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Qiumin Luo, Yeqiong Zhang, Zhipeng Li...
https://pubmed.ncbi.nlm.nih.gov/39640621