Trans-catheter Arterial Embolization Combined With p53 Gene Therapy for Treatment of Advanced Hepatocellular Carcinoma

Sponsor

Shenzhen SiBiono GeneTech Co.,Ltd (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02509169

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An open-labeled, randomized, active-controlled phase II study to investigate clinical efficacy and immunoreaction using trans-catheter arterial embolization (TAE) combined with p53 gene therapy in treatment of advanced hepatocellular carcinoma (HCC).

Condition or Disease	Intervention/Treatment	Phase
Advanced Hepatocellular Carcinoma (HCC)	Drug: TAE plus P53 gene Other: TAE	Phase 2

Detailed Description

Treatment options for advanced HCC are limited due to patients' poor condition, advanced stage, concomitant intra- and extra-liver diseases, and resistance to both chemo- and radio-therapy. Trans-catheter embolization (TAE) is a safe locoregional treatment for advanced HCC and p53 gene has multiple anticancer functions, and both methods do not have immune-inhibitory effects as chemo- or radio-therapy. The objectives of this study are to investigate clinical efficacy and immunoreaction usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced HCC.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Trans-catheter Arterial p53-gene-embolization Using Gelatin Sponge Particles in Treatment of Patients With Advanced Hepatocellular Carcinoma: A Phase II Study

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAE plus p53 gene Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month	Drug: TAE plus P53 gene Trans-catheter embolization combined with recombinant adenoviral human p53 gene therapy
Active Comparator: TAE Trans-catheter embolization (TAE) will be given once per month	Other: TAE Trans-catheter embolization

Arm

Intervention/Treatment

Experimental: TAE plus p53 gene

Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month

Drug: TAE plus P53 gene

Trans-catheter embolization combined with recombinant adenoviral human p53 gene therapy

Active Comparator: TAE

Trans-catheter embolization (TAE) will be given once per month

Other: TAE

Trans-catheter embolization

Outcome Measures

Primary Outcome Measures

overall survival [2 years]
overall survival will be follow up to 2 years

Secondary Outcome Measures

immuno-reaction (lymphocyte counts and subgroup ratios) [3 months]
The immune reaction after study treatment will be assessed every one week until 3 months after the first treatment
progression free survival [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

histopathologically diagnosed unresectable HCC
over 18 years old
with an Eastern Cooperative Oncology Group (ECOG) score of 0-2
with Barcelona Clinic Liver Cancer (BCLC) Stage of B or C
with Child-Pugh score A or B; with normal tests of hemogram, blood coagulation, liver and kidney function
signed the informed consent form.

Exclusion Criteria:

hypersensitive to study drug
With an abnormal coagulation condition or bleeding disorder
infections
with serious conditions which prevent using the study treatment
pregnant or lactating

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	first affiliated hospital in Dalian University	Dalian	Liaoning	China

Sponsors and Collaborators

Shenzhen SiBiono GeneTech Co.,Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shenzhen SiBiono GeneTech Co.,Ltd

ClinicalTrials.gov Identifier:

NCT02509169

Other Study ID Numbers:

TCAp53-110

First Posted:

Jul 27, 2015

Last Update Posted:

Jul 27, 2015

Last Verified:

Jul 1, 2015

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Jul 27, 2015