Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation
NCT ID: NCT02631499
Last Updated: 2015-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
256 participants
INTERVENTIONAL
2015-12-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Adjuvant TACE
TACE will be performed 4-6 weeks after hepatectomy in patients with preoperative CTC ≥2 Epirubicin, lipiodol and gelatin sponge articles are used in TACE.
TACE
TACE is performed 4-6 weeks after hepatectomy. Epirubicin and lipiodol are used in TACE.
Epirubicin
Epirubicin is a chemotherapy drug used in TACE
lipiodol
lipiodol is a kind of embolization material used in TACE
Control
no interventions were assigned after hepatectomy
No interventions assigned to this group
Interventions
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TACE
TACE is performed 4-6 weeks after hepatectomy. Epirubicin and lipiodol are used in TACE.
Epirubicin
Epirubicin is a chemotherapy drug used in TACE
lipiodol
lipiodol is a kind of embolization material used in TACE
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age from 18 to 75
* Child-Pugh class A
* ASA class I to II
* ECOG performance status Grade 0 or 1
* Preoperative CTC level ≥2 per 7.5 ml peripheral blood
* No residual tumor revealed by hepatic arterial angiography 4-6 weeks after hepatectomy
Exclusion Criteria
* Patients receiving concomitant local ablation or previous TACE
* Main portal vein tumor thrombus extraction during hepatectomy
* Hepatic arterial angiography before adjuvant TACE treatment reveals residual tumors.
* Presence of extra-hepatic or lymphatic metastasis
* Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin \< 25g/L or bilirubin \> 50micromol/L
* Renal impairment with creatinine \> 200micromol/L
* Severe concurrent medical illness persisting \> 6 weeks after hepatectomy
* History of other cancer
* Hepatic artery anomaly making TACE not possible
* Allergy to 5-Fluorouracil, Epirubicin or lipiodol
* Pregnant woman
* Informed consent not available
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Johnson & Johnson Medical, China
INDUSTRY
Fudan University
OTHER
Responsible Party
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Jia Fan
President of Shanghai Zhongshan Hospital
Principal Investigators
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Jia Fan, MD & PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital, Fudan University
Locations
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Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, China
Xinhua Hospital, Affliated with Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, China
Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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References
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Sun YF, Xu Y, Yang XR, Guo W, Zhang X, Qiu SJ, Shi RY, Hu B, Zhou J, Fan J. Circulating stem cell-like epithelial cell adhesion molecule-positive tumor cells indicate poor prognosis of hepatocellular carcinoma after curative resection. Hepatology. 2013 Apr;57(4):1458-68. doi: 10.1002/hep.26151. Epub 2013 Mar 4.
Zhong C, Guo RP, Li JQ, Shi M, Wei W, Chen MS, Zhang YQ. A randomized controlled trial of hepatectomy with adjuvant transcatheter arterial chemoembolization versus hepatectomy alone for Stage III A hepatocellular carcinoma. J Cancer Res Clin Oncol. 2009 Oct;135(10):1437-45. doi: 10.1007/s00432-009-0588-2. Epub 2009 May 1.
Ren ZG, Lin ZY, Xia JL, Ye SL, Ma ZC, Ye QH, Qin LX, Wu ZQ, Fan J, Tang ZY. Postoperative adjuvant arterial chemoembolization improves survival of hepatocellular carcinoma patients with risk factors for residual tumor: a retrospective control study. World J Gastroenterol. 2004 Oct 1;10(19):2791-4. doi: 10.3748/wjg.v10.i19.2791.
Other Identifiers
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CTC-HE-TACE
Identifier Type: -
Identifier Source: org_study_id