NCT02418988

Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma

Multicenter, Open-labeled, Controlled Phase II Study: Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Treatment options for advanced hepatocellular carcinoma (HCC) are limited due to patients' poor condition, advanced tumor, concomitant intra- and extra-liver diseases, and resistance to both chemo- and radio-therapy. Trans-catheter embolization (TAE) or Trans-catheter chemo-embolization (TACE) is the most widely used locoregional treatment for advanced HCC. But no solid evidences support the beneficial effect of the chemotherapy in TACE. Many advanced HCC patients also can't tolerate the locoregional chemotherapy. The p53 gene has multiple anticancer functions and does not have any of the immune-inhibitory effects of chemo- or radio-therapy. The objectives of this study are to investigate the efficacy and safety usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced HCC.

Detailed description

Study design: multicenter, open-labeled, active-controlled phase II study Study treatments: TACE combined with rAd-p53 injection vs.TACE. The treatments are given once per 21 days until the disease progression. For the experiment group, 2 X 1000,000,000,000 viral particles of rAd-p53 will be injected into the embolization artery. Study objectives: efficacy and safety of the study treatments Study endpoints: safety (adverse events, vital signs, lab tests, ECG and physical examination) and efficacy (progression-free survival, overall survival, and ECOG PS)

Conditions

• Advanced Adult Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	TACE plus rAd-p53 artery injection	Trans-catheter chemo-embolization (TACE) with rAd-p53 injection will be given every 21 days
DRUG	TACE	Trans-catheter chemo-embolization (TACE) without rAd-p53 injection will be given every 21 days

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-05-01
• Completion: 2017-12-01
• First posted: 2015-04-17
• Last updated: 2015-04-17

Locations

1 site across 1 country: China