Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC (NCT05484908) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC
China60 participantsStarted 2022-08-12
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. Other active liver diseases;
✕. Other malignancy;
✕. 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 transplantation;
What they're measuring
1
Mortality rate
Timeframe: 12 weeks
Trial details
NCT IDNCT05484908
SponsorThird Affiliated Hospital, Sun Yat-Sen University