Clinical Trial: NCT04317248 - My Cancer Genome

NCT04317248

Description:

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.

Related Conditions:

Hepatocellular Carcinoma

Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04317248

Trial Eligibility

Document

Title

Brief Title: "Cocktail" Therapy for Hepatitis B Related Hepatocellular Carcinoma
Official Title: Precision Study on "Cocktail" Therapy to Improve the Efficacy of Hepatitis B-related Hepatocellular Carcinoma

Clinical Trial IDs

ORG STUDY ID: 2019B110233002
NCT ID: NCT04317248

Conditions

Hepatocellular Carcinoma

Interventions

Drug	Synonyms	Arms
Cyclophosphamide	Endoxan	MSDCV immune therapy combined with TACE therapy
Multiple Signals loaded Dendritic Cells Vaccine	MSDCV	MSDCV immune therapy combined with TACE therapy

Purpose

Detailed 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.

Trial Arms

Name	Type	Description	Interventions
MSDCV immune therapy combined with radical surgery therapy	Experimental	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 Multiple Signals loaded Dendritic Cells Vaccine
Radical surgery therapy	No Intervention	Hepatocellular Carcinoma Radical surgery therapy: one time at a good operation time
MSDCV immune therapy combined with TACE therapy	Experimental	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 Multiple Signals loaded Dendritic Cells Vaccine
TACE therapy	No Intervention	Transcatheter Hepatic Arterial Chemoembolization (TACE) therapy: perform when necessary according to Subjects condition
MSDCV immune therapy combined with targeted agents therapy	Experimental	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 Multiple Signals loaded Dendritic Cells Vaccine
Targeted agents therapy	No Intervention	Targeted agents therapy: Sorafenib or Lenvatinib. For Sorafenib: 0.4g twice daily; for Lenvatinib: 12mg/8mg per day according to subjects condition

Eligibility Criteria

        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

Maximum Eligible Age:	70 Years
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Progression-Free-Survival (PFS), month
Time Frame:	240 weeks
Safety Issue:
Description:	The time from randomization until first documented progression or death from any cause，whichever came first

Secondary Outcome Measures

Measure:	serum AFP(alpha fetoprotein）, ng/ml
Time Frame:	240 weeks
Safety Issue:
Description:	Measured for each subjects at each visits

Measure:	serum PIVKA-II(Protein Induced by Vitamin K Absence or Antagonist-II), μg/L
Time Frame:	240 weeks
Safety Issue:
Description:	Measured for each subjects at each visits

Measure:	Overall Survival (OS), month
Time Frame:	240 weeks
Safety Issue:
Description:	The time from random assignment to death from any cause

Measure:	tumor size, mm
Time Frame:	240 weeks
Safety Issue:
Description:	Utilizing Liver CT or MR examination

Measure:	Number of participants with treatment-related adverse events
Time Frame:	240 weeks
Safety Issue:
Description:	Assessed by CTCAE v4.0

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Yuehua Huang

Trial Keywords

hepatocellular carcinoma
hepatitis B
Dendritic cells vaccine
cell therapy

Last Updated

October 29, 2020

Clinical Trials /

"Cocktail" Therapy for Hepatitis B Related Hepatocellular Carcinoma