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

ConditionsImmune-Mediated Hepatitis Liver Failure Hepatocellular Carcinoma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorThird Affiliated Hospital, Sun Yat-Sen University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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；

Disqualifiers

Other active liver diseases;

Other malignancy;

Pregnancy or lactation;

Human immunodeficiency virus infection or congenital immune deficiency diseases;

Trial design

Design model

Parallel

Treatments tested in this trial

DPMAS+LPE
Other intervention
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.
PE
Other intervention
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.
Comprehensive internal medical treatment
Other intervention
Patients will receive comprehensive internal medical treatment.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: DPMAS+LPE groupExperimental treatment 2 interventions

Group B: PE groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

Mortality rate

Mortality rate at 12-week follow-up.

Time frame

12 weeks

Secondary outcomes

Model for end-stage liver disease (MELD) score variation

Variation of MELD score at 12 weeks after treatment. MELD score = 9.57 × loge(creatinine mg/dl) + 3.78 × loge(TBIL mg/dl) + 11.20 × loge(PT-INR) + 6.43.

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Third Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov

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