A Basic-clinical Translational Research in Hepatitis B Virus (HBV)-Specific Antigen Peptides and HepG2 Cell Lysate Co-activated Dendritic Cells Combined With Transarterial Chemoembolization (TACE) in HBV-related HCC Treatment (BTRHBVAPHCLCDCCTCHBVHCCT)

Hepatocellular Carcinoma Clinical Trial

Official title:
A Basic-clinical Translational Research in Hepatitis B Virus (HBV)-Specific Antigen Peptides and HepG2 Cell Lysate Co-activated Dendritic Cells Combined With Transarterial Chemoembolization (TACE) in HBV-related HCC Treatment

Status Completed

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, dendritic cells activated by HBV antigen peptides and HepG2 cell protein lysate can efficiently present T cells with antigens of HCC to sensitize their antitumor properties meanwhile cyclophosphamide(CY) can effectively improve the microenvironment of immunity. Therefore, we put forward a new scientific therapy called "Activated Dendritic-cells Combined Cyclophosphamide" (ADCC) combining with TACE for patients with advanced hepatocellular carcinoma to prolong their survival time.

Clinical Trial Description

Patients who have good compliance complying with the inclusion criteria will be enrolled into our research. The 70 patients will be randomly assigned to experimental group and control group with the ratio of 1:1, one group (control group) will go on receiving the TACE treatment solely; another group (experimental group) after enrollment will receive TACE in the first course.Then 10ml blood is taken for activated dendritic cells culture.CY treatment will be performed on patients in reasonable dose two days before the second TACE.The day when the second TACE performed, these patients will receive activated-dendritic cells simultaneously. 31 days after the first TACE therapy, all patients are determined if they should continue an additional course by monitoring their blood parameters, tumor indicators and imaging examinations. Additionally, we are setting up a treatment course containing 31 days and going to change one course into 93 days after the third course. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03086564
Study type	Interventional
Source	Third Affiliated Hospital, Sun Yat-Sen University
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	May 1, 2017
Completion date	October 29, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04209491` - Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
Completed	`NCT03963206` - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE)	Phase 4
Completed	`NCT03268499` - TACE Emulsion Versus Suspension	Phase 2
Recruiting	`NCT05044676` - Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
Recruiting	`NCT05263830` - Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
Recruiting	`NCT05095519` - Hepatocellular Carcinoma Imaging Using PSMA PET/CT	Phase 2
Recruiting	`NCT05497531` - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers	N/A
Completed	`NCT05068193` - A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers	Phase 1
Active, not recruiting	`NCT03781934` - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations	Phase 1/Phase 2
Terminated	`NCT03655613` - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC	Phase 1/Phase 2
Active, not recruiting	`NCT03170960` - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT04242199` - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors	Phase 1
Completed	`NCT04401800` - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma	Phase 2
Withdrawn	`NCT05418387` - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona	N/A
Active, not recruiting	`NCT04039607` - A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma	Phase 3
Terminated	`NCT03970616` - A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma	Phase 1/Phase 2
Recruiting	`NCT04118114` - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors	Phase 2
Recruiting	`NCT06239155` - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT03642561` - Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE	Phase 2/Phase 3
Completed	`NCT03222076` - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer	Phase 2