Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma
NCT ID: NCT00921531
Last Updated: 2011-04-19
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
PHASE3
200 participants
INTERVENTIONAL
2009-06-30
2013-04-30
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
NONE
Study Groups
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Thalidomide and TACE
Thalidomide is used for adjuvant therapy for TACE
Thalidomide
Thalidomide is used for adjuvant therapy for TACE
Thalidomide will be given at the dose of 200 mg/day in beginning, with dose escalation of 100 mg/day each week, until to the dosage of 400 mg/day.
TACE
TACE (5-FU 1.0 g, OXP 150mg, MMC 10 mg, lipiodol 5-30 ml) will be performed every two months (defined as a course) until no radiological evidence of survival of tumor (based on contrast MRI) or 6 courses.
TACE only
TACE
TACE (5-FU 1.0 g, OXP 150mg, MMC 10 mg, lipiodol 5-30 ml) will be performed every two months (defined as a course) until no radiological evidence of survival of tumor (based on contrast MRI) or 6 courses.
Interventions
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Thalidomide
Thalidomide is used for adjuvant therapy for TACE
Thalidomide will be given at the dose of 200 mg/day in beginning, with dose escalation of 100 mg/day each week, until to the dosage of 400 mg/day.
TACE
TACE (5-FU 1.0 g, OXP 150mg, MMC 10 mg, lipiodol 5-30 ml) will be performed every two months (defined as a course) until no radiological evidence of survival of tumor (based on contrast MRI) or 6 courses.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years and ≤ 80 years
* At least one tumor nodule with one uni-dimension of ≥ 2 cm
* Child-Pugh Class A or B
* Total bilirubin ≤ 1.5 x upper limit of normal
* ALT and AST ≤ 2.0 x the upper limit of normal
* PT-INR\<2.3,PTT \< 1.5 x upper limit of normal
* Serum creatinine ≤ 1.5x upper limit of normal
* Peripheral white blood cell count of or more than 3×10(9)/L
* Peripheral platelet of or more than 50×10(9)/L
* Expected survival time not less than 3 months
* ECOG score 0-2
Exclusion Criteria
* Tumor involvement more than 70% of whole liver
* With extrahepatic metastasis
* Prior systemic chemotherapy or chemoembolization
* Congestive heart failure \> NYHA class 2
* History of HIV infection
* Active clinically serious infections (\> 2 NCI-CTC Version 3.0)
* Recurrence of HCC after liver transplantation
* Pregnant or breast-feeding
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
* Known or suspected allergy to any agent given in association with this trial
* Patients unable to swallow oral medication
* Inclined to thrombosis
* Inclined to hemorrhage or active hemorrhage with 1 month
18 Years
80 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Fudan University
Locations
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Liver Cancer Institute
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Fudan University,Shanghai,China
Other Identifiers
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LCI-09-06-15
Identifier Type: -
Identifier Source: secondary_id
LCI-THALIDOMIDE
Identifier Type: -
Identifier Source: org_study_id
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