Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC
Efficacy and Safety of Artificial Liver Support System Treatment for Immune Checkpoint Inhibitors Related Liver Failure in Patients With Hepatocellular Carcinoma
Third Affiliated Hospital, Sun Yat-Sen University
60 participants
Aug 12, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria9
- 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
Interventions
Patients will receive treatment of double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (LPE) for three times in two weeks. The volume of plasma adsorption in DPMAS is 5000\~6000 millilitre. The volume of fresh frozen plasma used in LPE is 1000 millilitre.
Patients will receive treatment of plasma exchange (PE) for three times in two weeks. The volume of fresh frozen plasma used in PE is 2000 millilitre.
Patients will receive comprehensive internal medical treatment.
Locations(1)
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NCT05484908