Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC
Recruiting now · Not applicable
Conditions studied: Immune-Mediated Hepatitis, Liver Failure, Hepatocellular Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05484908
- Run by
- Third Affiliated Hospital, Sun Yat-Sen University
- People needed
- 60
- Starts
- 2022-08-12
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2024-11-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
- Active bleeding, disseminated intravascular coagulation, thrombosis, or thrombotic disease;
- Patients received artificial liver support system treatment in one week before inclusion;
- Patients can not follow-up;
- Investigator considering inappropriate
Where it is running
- Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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