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

NCT ID: NCT02509169

Last Updated: 2015-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Advanced Hepatocellular Carcinoma (HCC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAE plus p53 gene

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

Group Type EXPERIMENTAL

TAE plus P53 gene

Intervention Type DRUG

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

TAE

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

Group Type ACTIVE_COMPARATOR

TAE

Intervention Type OTHER

Trans-catheter embolization

Interventions

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TAE plus P53 gene

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

Intervention Type DRUG

TAE

Trans-catheter embolization

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen SiBiono GeneTech Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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first affiliated hospital in Dalian University

Dalian, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuewei Zhang, MD and Ph D

Role: CONTACT

Gui Gao, MD, Ph D

Role: CONTACT

Facility Contacts

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Yuewei Zhang, MD, Ph D

Role: primary

Other Identifiers

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TCAp53-110

Identifier Type: -

Identifier Source: org_study_id

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