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

Primary Purpose

Immune-Mediated Hepatitis, Liver Failure, Hepatocellular Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DPMAS+LPE
PE
Comprehensive internal medical treatment
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune-Mediated Hepatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Third Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DPMAS+LPE group

PE group

Arm Description

30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment.

30 patients receive treatment of PE and comprehensive internal medical treatment.

Outcomes

Primary Outcome Measures

Mortality rate
Mortality rate at 12-week follow-up.

Secondary Outcome Measures

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.

Full Information

First Posted
July 30, 2022
Last Updated
July 30, 2022
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05484908
Brief Title
Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC
Official Title
Efficacy and Safety of Artificial Liver Support System Treatment for Immune Checkpoint Inhibitors Related Liver Failure in Patients With Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune-Mediated Hepatitis, Liver Failure, Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DPMAS+LPE group
Arm Type
Experimental
Arm Description
30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment.
Arm Title
PE group
Arm Type
Active Comparator
Arm Description
30 patients receive treatment of PE and comprehensive internal medical treatment.
Intervention Type
Other
Intervention Name(s)
DPMAS+LPE
Intervention 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.
Intervention Type
Other
Intervention Name(s)
PE
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Comprehensive internal medical treatment
Intervention Description
Patients will receive comprehensive internal medical treatment.
Primary Outcome Measure Information:
Title
Mortality rate
Description
Mortality rate at 12-week follow-up.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Model for end-stage liver disease (MELD) score variation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Other active liver diseases; Other malignancy; Pregnancy or lactation; 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; Patients received artificial liver support system treatment in one week before inclusion; Patients can not follow-up; Investigator considering inappropriate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenxiong Xu, Doctor
Phone
+8613760783281
Email
xuwenx@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Peng, Doctor
Phone
+8613533978874
Email
pliang@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenxiong Xu, Doctor
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenxiong Xu, Doctor
Phone
+8613760783281
Email
xuwenx@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study protocol, results and conclusions of this clinical trial will be published at academic conferences or in journals.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Proposals should be directed to xuwenx@mail.sysu.edu.cn. To gain access, data requestors will need to sign a data access agreement

Learn more about this trial

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

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