Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC

Launched by THIRD AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Jul 30, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how well an artificial liver support system (ALSS) can help patients with liver failure caused by immune checkpoint inhibitor treatments for liver cancer, specifically hepatocellular carcinoma (HCC). The main goal is to see if this treatment is both effective and safe for patients who are experiencing liver problems related to their cancer treatment.

To participate in this study, patients need to be between 18 and 65 years old, have a diagnosis of chronic hepatitis B, and currently have HCC while receiving immune checkpoint inhibitors. They should have had their last dose of treatment within the last three months. Participants will undergo careful monitoring throughout the trial to assess their health and the effects of the ALSS treatment. This study is currently recruiting participants, and it’s important to note that there are certain health conditions that may disqualify someone from joining, such as having other active liver diseases or certain serious illnesses. If you or a loved one qualify, this trial could provide a valuable opportunity to explore a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age from 18 to 65 years old;
• • 2. Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \> 0.5 year);
• • 3. 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;
• • 4. The level of hepatitis b virus DNA \< 2000 IU/mL；
• • 5. Serum aspartate aminotransferase/alanine aminotransferase \> 20 times upper limit of normal；serum total bilirubin\>10 times upper limit of normal；
• • 6. Prothrombin time international ratio \> 1.5;
• • 7. Platelets \> 50\*10 E9/L;
• • 8. Without intrahepatic bile duct dilation due to tumor progression.
• Exclusion Criteria:
• • 1. Other active liver diseases;
• • 2. Other malignancy;
• • 3. Pregnancy or lactation;
• • 4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
• • 5. Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events; other important organ dysfunctions or transplantation;
• • 6. Active bleeding, disseminated intravascular coagulation, thrombosis, or thrombotic disease;
• • 7. Patients received artificial liver support system treatment in one week before inclusion;
• • 8. Patients can not follow-up;
• • 9. Investigator considering inappropriate