"Cocktail" Therapy for Hepatitis B Related Hepatocellular Carcinoma
NCT ID: NCT04317248
Last Updated: 2020-10-29
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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UNKNOWN
PHASE2
600 participants
INTERVENTIONAL
2020-04-01
2022-04-30
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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MSDCV immune therapy combined with radical surgery therapy
Multiple Signals loaded Dendritic Cells Vaccine(MSDCV) immune therapy：one time every 4 weeks during 0 weeks to 20 weeks, about 5\*10\^7 cells per time, total 6 times; Hepatocellular Carcinoma Radical surgery therapy: one time at a good operation time before the first time of MSDCV immune therapy
Cyclophosphamide
Intravenous drip，250mg/m\^2 per time，two days before each times of MSDCV therapy，total 6 times, in order to improve the immunosuppressive microenvironment of tumor，reduce CD4+CD25+FOXP3+regulatory T cells (Tregs）
Multiple Signals loaded Dendritic Cells Vaccine
one time every 4 weeks during 0 weeks to 20 weeks, about 5\*10\^7 cells per time, intravenous driptotal 6 times;
Radical surgery therapy
Hepatocellular Carcinoma Radical surgery therapy: one time at a good operation time
No interventions assigned to this group
MSDCV immune therapy combined with TACE therapy
Multiple Signals loaded Dendritic Cells Vaccine(MSDCV) immune therapy：one time every 4 weeks during 0 weeks to 20 weeks, about 5\*10\^7 cells per time, total 6 times; Transcatheter Hepatic Arterial Chemoembolization (TACE) therapy: the first time of TACE therapy must perform before the first time of MSDCV immune therapy， then perform when necessary according to subjects condition
Cyclophosphamide
Intravenous drip，250mg/m\^2 per time，two days before each times of MSDCV therapy，total 6 times, in order to improve the immunosuppressive microenvironment of tumor，reduce CD4+CD25+FOXP3+regulatory T cells (Tregs）
Multiple Signals loaded Dendritic Cells Vaccine
one time every 4 weeks during 0 weeks to 20 weeks, about 5\*10\^7 cells per time, intravenous driptotal 6 times;
TACE therapy
Transcatheter Hepatic Arterial Chemoembolization (TACE) therapy: perform when necessary according to Subjects condition
No interventions assigned to this group
MSDCV immune therapy combined with targeted agents therapy
Multiple Signals loaded Dendritic Cells Vaccine(MSDCV) immune therapy：one time every 4 weeks during 0 weeks to 20 weeks, about 5\*10\^7 cells per time, total 6 times; Targeted agents therapy: Sorafenib or Lenvatinib. For Sorafenib: 0.4g twice daily; for Lenvatinib: 12mg/8mg per day according to subjects condition
Cyclophosphamide
Intravenous drip，250mg/m\^2 per time，two days before each times of MSDCV therapy，total 6 times, in order to improve the immunosuppressive microenvironment of tumor，reduce CD4+CD25+FOXP3+regulatory T cells (Tregs）
Multiple Signals loaded Dendritic Cells Vaccine
one time every 4 weeks during 0 weeks to 20 weeks, about 5\*10\^7 cells per time, intravenous driptotal 6 times;
Targeted agents therapy
Targeted agents therapy: Sorafenib or Lenvatinib. For Sorafenib: 0.4g twice daily; for Lenvatinib: 12mg/8mg per day according to subjects condition
No interventions assigned to this group
Interventions
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Cyclophosphamide
Intravenous drip，250mg/m\^2 per time，two days before each times of MSDCV therapy，total 6 times, in order to improve the immunosuppressive microenvironment of tumor，reduce CD4+CD25+FOXP3+regulatory T cells (Tregs）
Multiple Signals loaded Dendritic Cells Vaccine
one time every 4 weeks during 0 weeks to 20 weeks, about 5\*10\^7 cells per time, intravenous driptotal 6 times;
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with history of hepatitis B infection
* Male and female adult subjects (18～70 years old)
* Patients haven't received radiation therapy or chemotherapy or immunotherapy
* Normal renal function
* Blood routine test: Hb\>=9g/dL, white cell count\>=1.5\*10\^9/L, platelet count\>=50\*10\^9/L
* Liver function: bilirubin\<=50umol/L, aspartate aminotransferase (AST) or alanine aminotransferase(ALT)\<=5 times the upper limit of normal
* Child-Pugh score\<=9
* Human Chorionic Gonadotropin(HCG) test negative(-) if patients are women of reproductive ages
* Women of reproductive ages promise to contracept until therapy course has been finished for 3 months
* Patients who have signed up informed consents
Exclusion Criteria
* History of major surgery in last 4 weeks
* History of radiofrequency ablation in last 6 weeks
* Acute infections in last 2 weeks
* Child-Pugh scores\>9
* Patients with hepatic encephalopathy
* Patients with ascites needed drainage
* Patients have history of other cancer
* Patients have history of HIV
* Pregnant women
* Patients with severe diseases like cardiac dysfunction
* Patients with mental illness that influence signing informed consents
* HBV infection combined with other types of hepatitis
* Patients with autoimmune diseases
* Immunosuppressant drugs users
* Patients cannot follow our trial principle
18 Years
70 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Yuehua Huang
OTHER
Responsible Party
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Yuehua Huang
Laboratory director of hepatology，Deputy director of infection
Principal Investigators
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Yuehua Huang, doctorate
Role: PRINCIPAL_INVESTIGATOR
Third Affiliated Hospital, Sun Yat-Sen University
Locations
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Nanfang Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer center
Guangzhou, Guangdong, China
Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Zhongshan University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019B110233002
Identifier Type: -
Identifier Source: org_study_id