NCT05484908 Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC
| NCT ID | NCT05484908 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University |
| Condition | Immune-Mediated Hepatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-08-12 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-08-12 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Wenxiong Xu, Doctor
PRINCIPAL INVESTIGATOR
Third Affiliated Hospital, Sun Yat-Sen University
Frequently Asked Questions
Who can join the NCT05484908 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Immune-Mediated Hepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05484908 currently recruiting?
Yes, NCT05484908 is actively recruiting participants. Contact the research team at xuwenx@mail.sysu.edu.cn for enrollment information.
Where is the NCT05484908 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05484908 clinical trial?
NCT05484908 is sponsored by Third Affiliated Hospital, Sun Yat-Sen University. The principal investigator is Wenxiong Xu, Doctor at Third Affiliated Hospital, Sun Yat-Sen University. The trial plans to enroll 60 participants.