A RCT of TNF and ENT in the Treatment of Long-term Prognosis With Hepatitis B-related HCC After Curative Resection

  • STATUS
    Recruiting
  • participants needed
    706
  • sponsor
    Sun Yat-sen University
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Updated on 19 February 2024
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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 Tenofovir disoproxil fumarate, while the other half will receive Entecavir.

Description

Antiviral potency significantly differs among various antiviral agentsEntecavir and tenofovir disoproxil fumarate are equally recommendedas first-line treatments for patients with chronic hepatitis B (CHB). However, it is unclear whether treatment with these drugs is associated with equivalent clinical outcomes,especially impacts the risk of HCC recurrence. Entecavir and tenofovir disoproxil fumarate have comparable efficacy in achieving surrogate end points, including virologic response,but they do by different mechanisms .

Entecavir, a guanosine nucleoside analogue with activity against HBV reverse transcriptase (rt),is efficiently phosphorylated to the active triphosphate form, which has an intracellular half-life of 15 hours. By competing with the natural substrate deoxyguanosine triphosphate, entecavir triphosphate functionally inhibits all three activities of the HBV reverse transcriptase: (1) basepriming, (2) reverse transcription of the negative strand from the pregenomic messenger RNA,and (3) synthesis of the positive strand of HBV DNA.

Tenofovir fumarate is a cyclic nucleoside phosphine diester structural analog of adenosine monophosphate. Tenofovir disoproxil fumarate first needs to be converted to tenofovir by hydrolysis of the diester, followed by phosphorylation of cellular enzymes to form tenofovir diphosphate. Tenofovir diphosphate competes with the natural substrate 5'-deoxyadenosine triphosphate for its involvement in the synthesis of viral DNA, which, after entering the viral DNA strand, can cause DNA elongation to be blocked due to its lack of 3'-OH groups,thereby blocking the replication of the virus. Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerase alpha, beta and mitochondrial DNA polymerase gamma.

Details
Condition Hepatocellular Carcinoma Recurrent
Age 18-80 years
Treatment Tenofovir disoproxil fumarate 300mg, Entecavir 0.5 mg
Clinical Study IdentifierNCT04392700
SponsorSun Yat-sen University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 : WBC3.010^9/L ; PLT7510^9/L ; Hb100g/L Cr<133mmol/L ; ALT 150U/L ; AST 120U/L ; ALB30g/L ; TBIL34mmol/L INR < 1.5 ; APTT < 18 S

Exclusion Criteria

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 beganMyocardial infarction Unstable anginaCoronary artery bypass surgeryCerebrovascular Pulmonary embolism
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