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

SiBiono

Status and phase: Unknown; Phase 2

Conditions: Advanced Hepatocellular Carcinoma (HCC)

Treatments: Other: TAE; Drug: TAE plus P53 gene

Study type: Interventional

Funder types: Industry

Identifiers

NCT02509169

TCAp53-110

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

TAE plus p53 gene

Experimental group

Description:

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

Treatment:

Drug: TAE plus P53 gene

TAE

Active Comparator group

Description:

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

Treatment:

Other: TAE