Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC
NCT ID: NCT05484908
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2022-08-12
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DPMAS+LPE group
30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment.
DPMAS+LPE
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.
Comprehensive internal medical treatment
Patients will receive comprehensive internal medical treatment.
PE group
30 patients receive treatment of PE and comprehensive internal medical treatment.
PE
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
Patients will receive comprehensive internal medical treatment.
Interventions
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DPMAS+LPE
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
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
Patients will receive comprehensive internal medical treatment.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Wenxiong Xu
Associate Chief Physician
Principal Investigators
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Wenxiong Xu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Third Affiliated Hospital, Sun Yat-Sen University
Locations
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Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Luo Q, Zhang Y, Li Z, Chen J, Deng Z, Lai J, Chen X, Xie C, Peng L, Liu Y, Xu W. Efficacy and safety of artificial liver support system treatment for immune checkpoint inhibitors related liver failure in patients with hepatocellular carcinoma: Protocol for a randomized controlled clinical trial. Heliyon. 2024 Oct 9;10(20):e39095. doi: 10.1016/j.heliyon.2024.e39095. eCollection 2024 Oct 30.
Other Identifiers
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XWX4
Identifier Type: -
Identifier Source: org_study_id