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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02509169

Enrollment

Registered

2015-07-27

Start date

2014-10-31

Completion date

2016-12-31

Last updated

2015-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Hepatocellular Carcinoma (HCC)

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.

Interventions

DRUGTAE plus P53 gene

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

OTHERTAE

Trans-catheter embolization

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
overall survival	2 years	overall survival will be follow up to 2 years

Secondary

Measure	Time frame	Description
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	—

Countries

China

Contacts

Primary ContactYuewei Zhang, MD and Ph D

zhangyuewei1121@sina.com

Backup ContactGui Gao, MD, Ph D

scottgao1110@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026