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

Advanced Hepatocellular Carcinoma (HCC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02509169
• Other study ID #: TCAp53-110
• Status: Recruiting
• Phase: Phase 2
• First received: July 19, 2015
• Last updated: July 23, 2015
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2015
• Source: Shenzhen SiBiono GeneTech Co.,Ltd
• Contact: Yuewei Zhang, MD and Ph D
• Email: zhangyuewei1121[@]sina.com
• Is FDA regulated: No
• Health authority: China: Dalian Medical University
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma (HCC)
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• TAE plus P53 gene
Trans-catheter embolization combined with recombinant adenoviral human p53 gene therapy

Other:
• TAE
Trans-catheter embolization

Locations

Country	Name	City	State
China	first affiliated hospital in Dalian University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen SiBiono GeneTech Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	overall survival will be follow up to 2 years	2 years	No
Secondary	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	3 months	No
Secondary	progression free survival		2 years	Yes