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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

Criteria

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