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

Phase 2

• Conditions: Advanced Hepatocellular Carcinoma (HCC)
• Interventions: Drug: TAE plus P53 gene; Other: TAE

• Registration Number: NCT02509169
• Lead Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

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.

Study Timeline

• Study Start: 2014-10
• Status Verified: 2015-07
• Study First Submitted: 2015-07-19
• Study First Submitted QC: 2015-07-23
• Last Update Submitted: 2015-07-23
• Study First Posted: 2015-07-27
• Last Update Posted: 2015-07-27
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAE plus p53 gene	TAE plus P53 gene	Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
TAE	TAE	Trans-catheter embolization (TAE) will be given once per month

Primary Outcome Measures

Name	Time	Method
overall survival	2 years	overall survival will be follow up to 2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

first affiliated hospital in Dalian University; 🇨🇳 Dalian, Liaoning, China