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

July 23, 2015 updated by: Shenzhen SiBiono GeneTech Co.,Ltd

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • first affiliated hospital in Dalian University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 2 years
overall survival will be follow up to 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: 2 years
2 years
immuno-reaction (lymphocyte counts and subgroup ratios)
Time Frame: 3 months
The immune reaction after study treatment will be assessed every one week until 3 months after the first treatment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen SiBiono GeneTech Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

July 19, 2015

First Submitted That Met QC Criteria

July 23, 2015

First Posted (ESTIMATE)

July 27, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

July 27, 2015

Last Update Submitted That Met QC Criteria

July 23, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCAp53-110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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