"Cocktail" Therapy for Hepatitis B Related Hepatocellular Carcinoma

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04317248
Study type	Interventional
Source	Third Affiliated Hospital, Sun Yat-Sen University
Contact	Yuehua HYuang, doctorate
Phone	0086-13822232795
Email	huangyh53@mail.sysu.edu.cn
Status	Recruiting
Phase	Phase 2
Start date	April 1, 2020
Completion date	April 30, 2022

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
Active, not 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	`NCT03642561` - Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE	Phase 2/Phase 3
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
Completed	`NCT03222076` - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer	Phase 2