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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04317248
Other study ID # 2019B110233002
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 1, 2020
Est. completion date April 30, 2022

Study information

Verified date October 2020
Source Third Affiliated Hospital, Sun Yat-Sen University
Contact Yuehua HYuang, doctorate
Phone 0086-13822232795
Email huangyh53@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The effect of anti-tumor treatment is not satisfying in HBV-related hepatocellular carcinoma (HBV-HCC) for reasons that HBV-HCC carries highly heterogeneous antigens to facilitate cancer cells escaping from immune surveillance and constructs an immunosuppressive microenvironment. Correspondingly, multiple signals loaded dendritic cells vaccine can efficiently present T cells with antigens of HCC sensitize their antitumor properties meanwhile low dose cyclophosphamide (CY) can effectively improve the microenvironment of immunity. Therefore, we put forward a new scientific therapy called "multiple signals loaded dendritic cells vaccine combined low dose of cyclophosphamide" combining with radical surgery or TACE or targeted agents for patients with hepatocellular carcinoma to prolong their survival time.


Description:

Detailed Description Patients who have good compliance complying with the inclusion criteria will be enrolled into our research. The 600 patients will be randomly assigned to experimental group and control group with the ratio of 1:1, control group will receive radical surgery or TACE or targeted agent treatment solely; another group (experimental group) after enrollment will radical surgery or TACE or targeted agent treatment in the first course. Then 20ml blood is taken for multiple signals loaded dendritic cells (MSDCV) culture (cell culture takes 7 days). Low dose (250mg/m^2) CY treatment will be performed on patients two days before the MSDCV treatment. The MSDCV combined CY therapy will perform per 4 weeks, total 6 times. All patients are evaluated the safety and efficacy of treatment by monitoring their blood parameters, tumor indicators and imaging examinations at each visit.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - In accordance with AASLD guidelines for the diagnosis of hepatocellular carcinoma,histology or imaging confirmed as primary hepatocellular carcinoma - 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: - Extrahepatic metastasis of hepatocellular carcinoma oHistory of embolism, chemotherapy or radiation - 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

Study Design


Intervention

Drug:
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)
Biological:
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;

Locations

Country Name City State
China Nanfang Hospital Guangzhou Guangdong
China Sun Yat-sen University Guangzhou Guangdong
China Sun Yat-sen University Cancer center Guangzhou Guangdong
China The Third Affiliated Hospital of Zhongshan University Guangzhou Guangdong

Sponsors (3)

Lead Sponsor Collaborator
Yuehua Huang Nanfang Hospital of Southern Medical University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-Free-Survival (PFS), month The time from randomization until first documented progression or death from any cause,whichever came first 240 weeks
Secondary serum AFP(alpha fetoprotein), ng/ml Measured for each subjects at each visits 240 weeks
Secondary serum PIVKA-II(Protein Induced by Vitamin K Absence or Antagonist-II), µg/L Measured for each subjects at each visits 240 weeks
Secondary Overall Survival (OS), month The time from random assignment to death from any cause 240 weeks
Secondary tumor size, mm Utilizing Liver CT or MR examination 240 weeks
Secondary Number of participants with treatment-related adverse events Assessed by CTCAE v4.0 240 weeks
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