Status:
TERMINATED
Tenofovir Antiviral Therapy Following Transarterial Chemoembolization for HBV Related Hepatocellular Carcinoma
Lead Sponsor:
Taichung Veterans General Hospital
Collaborating Sponsors:
Gilead Sciences
Taipei Institute of Pathology
Conditions:
Chronic Hepatitis B
Hepatocellular Carcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
Hepatocellular carcinoma (HCC) is one of the most common solid cancers worldwide, and chronic hepatitis B virus (HBV) infection is the most common etiology of HCC in Asia. Transarterial chemoembolizat...
Detailed Description
This is randomized double-blind placebo-controlled trial that will be conducted in referral teaching hospitals in Taiwan. This trial will recruit 320 patients fulfilling all of the following criteria:...
Eligibility Criteria
Inclusion
- more than 20 years old
- HCCs diagnosed by AASLD image criteria or pathology
- Intermediate-stage HCCs that TACE is indicated
- chronic HBV carrier with detectable HBV DNA in blood
- ECOG performance status (PST) 0-2
- Child-Pugh score ≦7
- serum bilirubin \< 2 mg/dL
- prothrombin time prolongation \< 3 seconds
- willingness to adhere to treatment and follow-up plans -
Exclusion
- any vascular invasion by tumors
- extra-hepatic metastasis
- concurrent any other malignancy
- concomitant immunosuppressive therapy
- HCC recurrence within 2 years of previous curative treatment
- antiviral therapy for chronic hepatitis B within 6 months before HCC diagnosis
- concomitant other therapies for HCC except TACE
- liver cirrhosis with severe gastroesophageal varices (EVF3 or with red color sign), poorly-controlled ascites or hepatic encephalopathy
- contraindication for invasive procedures such as recent gastrointestinal bleeding or cerebral hemorrhage
- contraindication to TACE such as allergy to contrast, pregnancy, sepsis, etc.
- chronic renal failure with eGFR \< 60
- concurrent any other chronic viral hepatitis with HCV, HDV, or HIV) -
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2018
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT01872988
Start Date
September 1 2012
End Date
February 1 2018
Last Update
September 4 2014
Active Locations (4)
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1
Chia-Yi Christine Hospital
Chiayi City, Taiwan, 539
2
E-Da Hospital
Kaohsiung City, Taiwan, 824
3
Taichung Veterans General Hospital
Taichung, Taiwan, 407
4
Mackay Memorial Hosp
Taipei, Taiwan, 104