Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using TACE With Antiangiogenesis
NCT ID: NCT00518557
Last Updated: 2009-01-22
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
NA
60 participants
INTERVENTIONAL
2007-04-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
All patients of this arm are treated by TACE together with Andostatin.
Transcatheter Arterial Chemoembolization
The interventional procedure is performed as following steps: 1)transcatheter hepatic arterial angiography(including any feeding arteries to the tumor) is performed under a DSA unit; 2) super selectively catheterizaton of feeding arteries to the tumor is reached; 3)30 mg of Andostatin (Simcere Co. China) mixtured with 5 ml Lipiodol is injected into the tumor via the feeding arteries; 4) followed by 10 mg of Epifubicin mixtured with 5 ml of Lipiodol; 5) All feeding arteries to the tumor are occluded which is confirmed by re-angiography.
2
All patients of this arm are treated by TACE alone: only mixture of Epirubicin and Lipiodol is injected into the feeding arteries of the tumor, without injection of Andostatin.
Transcatheter Arterial Chemoembolization
The interventional procedure is performed as following steps: 1)transcatheter hepatic arterial angiography(including any feeding arteries to the tumor) is performed under a DSA unit; 2) super selectively catheterizaton of feeding arteries to the tumor is reached; 3)30 mg of Andostatin (Simcere Co. China) mixtured with 5 ml Lipiodol is injected into the tumor via the feeding arteries; 4) followed by 10 mg of Epifubicin mixtured with 5 ml of Lipiodol; 5) All feeding arteries to the tumor are occluded which is confirmed by re-angiography.
Interventions
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Transcatheter Arterial Chemoembolization
The interventional procedure is performed as following steps: 1)transcatheter hepatic arterial angiography(including any feeding arteries to the tumor) is performed under a DSA unit; 2) super selectively catheterizaton of feeding arteries to the tumor is reached; 3)30 mg of Andostatin (Simcere Co. China) mixtured with 5 ml Lipiodol is injected into the tumor via the feeding arteries; 4) followed by 10 mg of Epifubicin mixtured with 5 ml of Lipiodol; 5) All feeding arteries to the tumor are occluded which is confirmed by re-angiography.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Child-Pugh Child A or B
* Age \>= 18
* Measurable disease by RECIST criteria;
* Performance status ECOG 0-2
* Previous local therapy completed \> 4 weeks
* Written informed consent signed
* Normal organ and marrow function defined as:
Haematopoietic:
* WBC ≥ 3,000/µlplatelet count \> 80,000/mm3
* haemoglobin \> 9g/dL
* Hepatic: Albumin ≥ 2.8 g/dl.serum total bilirubin ≤ 3 mg/dl; AST or ALT \< 5 x ULN
* Renal: creatinine \< 1.5 x ULN
Exclusion Criteria
* Prior or concomitant chemotherapy or radiation therapy
* VEGF/VEGFR- inhibitors or other anti-angiogenesis agents
* Severe and/or uncontrolled medical conditions:
* Congestive heart failure, serious cardiac arrhythmia, active coronary artery
* Severe renal impairment
* Patients who anticipate receiving major surgery during the course of the
* Pregnant or breastfeeding patients
* Evidence of bleeding diathesis
18 Years
70 Years
ALL
No
Sponsors
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Southeast University, China
OTHER
Principal Investigators
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Gao-Jun Teng, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Zhongda Hospital, Southeast University, Nanjing, China
Locations
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Department of Interventional Radiology, Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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SIMCERE-123456
Identifier Type: -
Identifier Source: org_study_id
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