Status:
UNKNOWN
A RCT of TNF and ENT in the Treatment of Long-term Prognosis With Hepatitis B-related HCC After Curative Resection
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma Recurrent
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study evaluates the addition of Tenofovir and Entecavir in the treatment of Hepatitis B-related hepatocellular carcinoma after curative resection in adults. Half of participants will receive Teno...
Detailed Description
Antiviral potency significantly differs among various antiviral agents，Entecavir and tenofovir disoproxil fumarate are equally recommendedas first-line treatments for patients with chronic hepatitis B...
Eligibility Criteria
Inclusion
- age 18 to 70 years
- Positive test for hepatitis B surface antigen (HBsAg) and negative tests for antibodies to hepatitis C virus (HCV-Ab) or to human immunodeficiency virus
- Clinical diagnosis is consistent with HCC and histopathological result of the resected specimens being HCC
- No previous treatment of HCC and no previous treatment of hepatitis B with nucleoside or nucleotide analogues or both; no previous treatment with interferon or other immunomodulators
- BCLC stage 0, A or a solitary tumor with a diameter \>5cm
- No extrahepatic metastasisc
- No radiologic evidence of invasion into major portal/hepatic venous branches
- Good liver function with Child-Pugh Class A or Child - Pugh Class B (If B Child - Pugh score ≤7 ) and baseline serum alanine aminotransferase (ALT) level less than 3 times the upper limit of normal (reference range \<40IU/L), with no history of encephalopathy, ascites refractory to diuretics, esophagogastric variceal bleeding
- Good renal function (a serum creatinine level\<133mmol/L)
- Negative resection margin (R0 resection)
- Laboratory blood tests : WBC≥≥3.0×10\^9/L ; PLT≥75×10\^9/L ; Hb≥100g/L Cr\<133mmol/L ; ALT≤ 150U/L ; AST ≤ 120U/L ; ALB≥30g/L ; TBIL≤34mmol/L INR \< 1.5 ; APTT \< 18 S
Exclusion
- Eligible patients were excluded if they refused to participate
- Histopathological result of the resected specimens being not HCC
- History of antiviral therapy
- History of receive treatment of HCC， include drugs 、radiofrequency ablation transcatheter arterial chemoembolization or resection
- age﹤ 18 or ﹥70 years
- Pregnant or lactating women
- Poor liver function and poor renal function
- Suffering from other serious acute or chronic physical or mental illness
- The following occurred before the study began：Myocardial infarction、 Unstable angina、Coronary artery bypass surgery、Cerebrovascular 、 Pulmonary embolism
Key Trial Info
Start Date :
July 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 25 2024
Estimated Enrollment :
706 Patients enrolled
Trial Details
Trial ID
NCT04392700
Start Date
July 25 2019
End Date
July 25 2024
Last Update
May 19 2020
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060