Status:
UNKNOWN
Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma
Lead Sponsor:
Fudan University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Chemoembolization (TACE) is used in the majority of advanced hepatocellular carcinomas. Randomized clinical trials indicated that TACE improves overall survival in patients with good liver function (C...
Eligibility Criteria
Inclusion
- Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
- 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
- Tumor thrombi in main branch of portal vein
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00921531
Start Date
June 1 2009
End Date
April 1 2013
Last Update
April 19 2011
Active Locations (1)
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1
Liver Cancer Institute
Shanghai, Shanghai Municipality, China, 200032