A Phase 2 interventional study of TACE plus rAd-p53 artery injection and TACE in Advanced Adult Hepatocellular Carcinoma, sponsored by Shenzhen SiBiono GeneTech Co.,Ltd. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-04-17.
Sponsored by Shenzhen SiBiono GeneTech Co.,Ltd · Phase 2, Interventional, and Prevention
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.
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)
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's planned enrollment of 120 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Shenzhen SiBiono GeneTech Co.,Ltd is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
TACE plus rAd-p53 artery injection'
Drug: TACE plus rAd-p53 artery injection
TACE will be applied alone
Drug: TACE
Trans-catheter chemo-embolization (TACE) with rAd-p53 injection will be given every 21 days
Also known as: no other name
Trans-catheter chemo-embolization (TACE) without rAd-p53 injection will be given every 21 days
Also known as: no other name
overall survival
overall survival
Time frame: tumor assessment will be performed every 6 weeks from starting study treatment to death or 2 years later
safety as assessed by adverse events, vital sign, lab tests, ECG and physical examination
safety variables: adverse events, vital sign, lab tests, ECG and physical examination
Time frame: from the first study treatment to the 30 days after the last treatment (on an average of 6 months from the start treatment)
progression-free survival
time to disease progression (death or progression), or censored
Time frame: tumor assessment will be performed every 6 weeks from starting study treatment to disease progression or 2 years later
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Shenzhen SiBiono GeneTech Co.,Ltd