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

Primary Purpose

Advanced Hepatocellular Carcinoma (HCC)

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TAE plus P53 gene
TAE
Sponsored by
Shenzhen SiBiono GeneTech Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma (HCC)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • first affiliated hospital in Dalian UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAE plus p53 gene

TAE

Arm Description

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

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

Outcomes

Primary Outcome Measures

overall survival
overall survival will be follow up to 2 years

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2015
Last Updated
July 23, 2015
Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02509169
Brief Title
Trans-catheter Arterial Embolization Combined With p53 Gene Therapy for Treatment of Advanced Hepatocellular Carcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma (HCC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAE plus p53 gene
Arm Type
Experimental
Arm Description
Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
Arm Title
TAE
Arm Type
Active Comparator
Arm Description
Trans-catheter embolization (TAE) will be given once per month
Intervention Type
Drug
Intervention Name(s)
TAE plus P53 gene
Intervention Description
Trans-catheter embolization combined with recombinant adenoviral human p53 gene therapy
Intervention Type
Other
Intervention Name(s)
TAE
Intervention Description
Trans-catheter embolization
Primary Outcome Measure Information:
Title
overall survival
Description
overall survival will be follow up to 2 years
Time Frame
2 years
Secondary Outcome Measure Information:
Title
immuno-reaction (lymphocyte counts and subgroup ratios)
Description
The immune reaction after study treatment will be assessed every one week until 3 months after the first treatment
Time Frame
3 months
Title
progression free survival
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuewei Zhang, MD and Ph D
Email
zhangyuewei1121@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gui Gao, MD, Ph D
Email
scottgao1110@gmail.com
Facility Information:
Facility Name
first affiliated hospital in Dalian University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuewei Zhang, MD, Ph D
Email
zhangyuewei1121@sina.com

12. IPD Sharing Statement

Learn more about this trial

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

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