February 16, 2013
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June 5, 2013
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March 16, 2017
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January 2013
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January 2018 (Final data collection date for primary outcome measure)
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Overall survival time [ Time Frame: 3 years ]
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Same as current
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- Number of adverse events [ Time Frame: 30 days ]
Number of adverse events, and number of patients who developed adverse event. Postoperative adverse events were graded based on the Common Terminology Criteria for Adverse Events ( CTCAE )
- Tumor response [ Time Frame: 12 weeks ]
Tumor response based on modified RECIST
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Same as current
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Not Provided
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Not Provided
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TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma
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Phase Ⅲ Trial of Transcatheter Arterial Chemoembolization(TACE) Plus Recombinant Human Adenovirus Type 5 Injection for Unresectable Hepatocellular Carcinoma (HCC)
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The purpose of this study is to determine if TACE plus Recombinant Human Adenovirus Type 5 Injection will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery or local ablative therapy.
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Transarterial chemoembolization (TACE) is currently one of the mainstays of palliative treatments worldwide for patients with unresectable Hepatocellular Carcinoma(HCC).However, the long term outcomes were generally poor for HCC patients treated with TACE. Recombinant Human Adenovirus Type 5, an E1B gene deleted adenovirus, is known to have a significant antitumor activity. In addition, local injection of recombinant human adenovirus type 5 can enhance the effect of antitumor therapies (chemotherapy and radiotherapy). The hypothesis is that patients with unresectable HCC may benefit from recombinant human adenovirus type 5 in combination with TACE.
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Interventional
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Phase 3
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
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Hepatocellular Carcinoma
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- Drug: Recombinant Human Adenovirus Type 5 Injection
After identifying the target artery of HCC, Recombinant Human Adenovirus Type 5 Injection(15.0*1011vp:0.5ml*3) will be first infused through the target artery
- Procedure: Transartery Chemoembolization
Transartery chemoembolization with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg)and followed with embolization with lipiodol or/and polyvinyl alcohol particles.
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- Active Comparator: TACE Only
TACE with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg)and followed with embolization with lipiodol or/and polyvinyl alcohol particles.
Intervention: Procedure: Transartery Chemoembolization
- Experimental: TACE Plus Adenovirus
After identifying the target artery of HCC, Recombinant Human Adenovirus Type 5 Injection(15.0*1011vp:0.5ml*3) will be first infused through the target artery of HCC patient and followed with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg) and lipiodol emulsion or/and polyvinyl alcohol particles(dependent on the tumor size) Procedure: TACE (Transcatheter arterial chemoembolization)
Interventions:
- Drug: Recombinant Human Adenovirus Type 5 Injection
- Procedure: Transartery Chemoembolization
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- Llovet JM, Bustamante J, Castells A, Vilana R, Ayuso Mdel C, Sala M, Brú C, Rodés J, Bruix J. Natural history of untreated nonsurgical hepatocellular carcinoma: rationale for the design and evaluation of therapeutic trials. Hepatology. 1999 Jan;29(1):62-7.
- Lo CM, Ngan H, Tso WK, Liu CL, Lam CM, Poon RT, Fan ST, Wong J. Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology. 2002 May;35(5):1164-71.
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- Lee KH, Liapi E, Ventura VP, Buijs M, Vossen JA, Vali M, Geschwind JF. Evaluation of different calibrated spherical polyvinyl alcohol microspheres in transcatheter arterial chemoembolization: VX2 tumor model in rabbit liver. J Vasc Interv Radiol. 2008 Jul;19(7):1065-9. doi: 10.1016/j.jvir.2008.02.023. Epub 2008 Apr 10.
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- Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. Review.
- Mullen JT, Tanabe KK. Viral oncolysis. Oncologist. 2002;7(2):106-19. Review.
- Benedict CA, Norris PS, Prigozy TI, Bodmer JL, Mahr JA, Garnett CT, Martinon F, Tschopp J, Gooding LR, Ware CF. Three adenovirus E3 proteins cooperate to evade apoptosis by tumor necrosis factor-related apoptosis-inducing ligand receptor-1 and -2. J Biol Chem. 2001 Feb 2;276(5):3270-8. Epub 2000 Oct 24.
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- Bauzon M, Castro D, Karr M, Hawkins LK, Hermiston TW. Multigene expression from a replicating adenovirus using native viral promoters. Mol Ther. 2003 Apr;7(4):526-34.
- Hermiston TW, Kuhn I. Armed therapeutic viruses: strategies and challenges to arming oncolytic viruses with therapeutic genes. Cancer Gene Ther. 2002 Dec;9(12):1022-35. Review.
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Unknown status
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266
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120
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January 2018
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January 2018 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
Exclusion Criteria:
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Tumor factors
- Presence of extrahepatic metastasis
- Predominantly infiltrative lesion
- Diffuse tumor morphology with extensive lesions involving both lobes.
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Vascular complications
- Hepatic artery thrombosis, or
- Partial or complete thrombosis of the main portal vein, or
- Tumor invasion of portal branch of contralateral lobe, or
- Hepatic vein tumor thrombus, or
- Significant arterioportal shunt not amenable to shunt blockage
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Liver function
- Advanced liver disease: ascites, hepatic encephalopathy
- Patients with clinically significant gastrointestinal bleeding within the 30 days prior to study entry.
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Others
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Sexes Eligible for Study: |
All |
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18 Years to 70 Years (Adult, Older Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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China
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NCT01869088
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HCC-120402
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Yes
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Not Provided
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Not Provided
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Shi Ming, Sun Yat-sen University
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Sun Yat-sen University
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Not Provided
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Principal Investigator: |
Ming Shi, MD |
Cancer Center, Sun Yat-set University |
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Sun Yat-sen University
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March 2017
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