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Trial Title:
Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC
NCT ID:
NCT05484908
Condition:
Immune-Mediated Hepatitis
Liver Failure
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Failure
Hepatic Insufficiency
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
DPMAS+LPE
Description:
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.
Arm group label:
DPMAS+LPE group
Intervention type:
Other
Intervention name:
PE
Description:
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.
Arm group label:
PE group
Intervention type:
Other
Intervention name:
Comprehensive internal medical treatment
Description:
Patients will receive comprehensive internal medical treatment.
Arm group label:
DPMAS+LPE group
Arm group label:
PE group
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.
Detailed description:
Immune checkpoint inhibitors (ICIs) are commonly used for advanced stage of
hepatocellular carcinoma (HCC) in recent years. The incident rate of Grade 4 immune
checkpoint inhibitors-induced immune mediated hepatitis reaches 14.5%. Since these
patients usually develop into liver failure, it is urgent to find out a more suitable
therapy. Artificial liver support system (ALSS) treatment has been proved to effectively
control both immune mediated hepatitis and liver failure, it may be a new therapy for
immune checkpoint inhibitors-induced liver failure (ICIs-LF) in patients with HCC.
Therefore, this study aims to investigate the efficacy and safety of ALSS treatment,
including the classic mode of plasma exchange (PE) and new combination mode of double
plasma molecular adsorption system (DPMAS) with sequential low-dose plasma exchange
(LPE), for ICIs-LF in patients with HCC. Sixty patients with HCC and ICIs-LF will be
enrolled in this study. The participants are randomly divided into trial group
(DPMAS+LPE, and comprehensive internal medical treatment) and control group (PE and
comprehensive internal medical treatment). Symptoms, signs, laboratory tests results,
adverse events, mortality rates are recorded from treatment baseline to 12 weeks.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Third Affiliated Hospital of Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510630
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenxiong Xu, Doctor
Phone:
+8613760783281
Email:
xuwenx@mail.sysu.edu.cn
Start date:
August 12, 2022
Completion date:
August 31, 2024
Lead sponsor:
Agency:
Third Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Source:
Third Affiliated Hospital, Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05484908