Clinical trial · Interventional
RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection
The Different Effects of Nucleotide and Nucleoside Analogues on the Prognosis of Hepatitis B Virus-Related Hepatocellular Carcinoma Patients After Curative Resection:a Randomized Controlled Trial
- 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)
In Asia, hepatocellular carcinoma (HCC) commonly occurred in the underlying hepatitis B virus (HBV)-related liver disease.Curative therapies could improve the prognosis of HCC patients. However, tumor recurrence after curative therapy remains high with a 5-year recurrence rate \>70%.The risk for HCC development is increased for patient with HBV infection,but there was no consensus about which kind of oral antiviral treatment was the best option in the prevention of HBV related HCC recurrence after curative treatment.Therefore, we conducted this study to investigate the different effects of nucleotides(TDF) and nucleosides(ETV) on the prognosis of HBV-related HCC after curative resection.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HBV Coinfection | — | UNRESOLVED | — |
| HCC | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Entecavir | Drug | — | UNRESOLVED |
| Tenofovir Disoproxil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ETV group
- description
- group in which patients take ETV as antiviral therapy after curative treatment
- interventionNames
- Drug: Entecavir
- type
- EXPERIMENTAL
- label
- TDF group
- description
- group in which patients take TDF as antiviral therapy after curative treatment
- interventionNames
- Drug: Tenofovir Disoproxil
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- 1,3,5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: 1. older than 18 years and less than 69 years old; 2. HBsAg positive HCV antibody negative and HIV antibody negative; 3. HBV-DNA\>200 IU/mL; 4. BCLC(Barcelona Clinic Liver Cancer) staging O and A stage; 5. Platelet100×10\^9/L; 6. Liver function Child-Pugh A,with no invasion in portal vein, hepatic vein and two large branches, no extrahepatic metastasis; 7. Creatinine clearance rate≥ 70 mL/min; 8. Antiviral treatment was not performed before surgery or antiviral treatment was accepted in a short term (\<3 months); 9. No treatment was performed before the operation. The results of postoperatively histopathological biopsy were HCC; 10. The patients agree to participate in the clinical trial. Exclusion Criteria: 1. The image found extrahepatic lymph nodes or visceral metastasis, the existence of large vascular invasion, the existence of bile duct embolus in the first operation; 2. The patient combined with a malignant tumor of other organs or had a history of other malignant tumors in other organs; 3. Liver function decompensation, such as: upper gastrointestinal bleeding, refractory ascites, coagulation dysfunction and so on; 4. contraindications to surgery; 5. Patients with poor compliance and not adhered to the follow-ups; 6. Patients refused to participate in the clinical trial.
References
Publications (0)
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