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NCT05484908Recruiting

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

Source: ClinicalTrials.gov · Last updated 29 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
30 Jul 2022
Start date
12 Aug 2022
Primary completion date
31 Dec 2024
Lead sponsor
Third Affiliated Hospital, Sun Yat-Sen University
NCT number
NCT05484908

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 12 Aug 2022 to the primary completion date, 31 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients received artificial liver support system treatment in one week before inclusion;

Other illness

  • Other active liver diseases;
  • Other malignancy;
  • 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;

Other

  • Pregnancy or lactation;
  • Patients can not follow-up;
  • Investigator considering inappropriate

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Third Affiliated Hospital of Sun Yat-sen University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.