Clinical trial · Interventional
A RCT of TNF and ENT in the Treatment of Long-term Prognosis With Hepatitis B-related HCC After Curative Resection
A Prospective Randomized Controlled Trial of Tenofovir and Entecavir in the Treatment of Long-term Prognosis in Patients With Hepatitis B-related Hepatocellular Carcinoma After Curative Resection
NCT04392700CI-TRIAL-00045141unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma Recurrent | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Entecavir 0.5 mg | Drug | — | UNRESOLVED |
| Tenofovir disoproxil fumarate 300mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- group A
- description
- drugs:tenofovir disoproxil fumarate, dose:300mg/d
- interventionNames
- Drug: Tenofovir disoproxil fumarate 300mg
- type
- ACTIVE_COMPARATOR
- label
- group B
- description
- drugs:entecavir dose: 0.5 mg/d
- interventionNames
- Drug: Entecavir 0.5 mg
Primary outcomes (1)
- measure
- Recurrence of HCC
- timeFrame
- 36 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. age 18 to 70 years 2. Positive test for hepatitis B surface antigen (HBsAg) and negative tests for antibodies to hepatitis C virus (HCV-Ab) or to human immunodeficiency virus 3. Clinical diagnosis is consistent with HCC and histopathological result of the resected specimens being HCC 4. 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 5. BCLC stage 0, A or a solitary tumor with a diameter \>5cm 6. No extrahepatic metastasisc 7. No radiologic evidence of invasion into major portal/hepatic venous branches 8. 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 9. Good renal function (a serum creatinine level\<133mmol/L) 10. Negative resection margin (R0 resection) 11. 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 Criteria: 1. Eligible patients were excluded if they refused to participate 2. Histopathological result of the resected specimens being not HCC 3. History of antiviral therapy 4. History of receive treatment of HCC, include drugs 、radiofrequency ablation transcatheter arterial chemoembolization or resection 5. age﹤ 18 or ﹥70 years 6. Pregnant or lactating women 7. Poor liver function and poor renal function 8. Suffering from other serious acute or chronic physical or mental illness 9. The following occurred before the study began:Myocardial infarction、 Unstable angina、Coronary artery bypass surgery、Cerebrovascular 、 Pulmonary embolism
References
Publications (0)
Data not yet available
No reference posted for this study.