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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014629
Enrollment
Unknown
Registered
2018-01-24
Start date
2018-02-10
Completion date
Unknown
Last updated
2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatitis B virus–related hepatocellular carcinoma

Interventions

1:Orally entecavir
2:Oral tenofovir

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. older than 18 years and less than 69 years old; 2. HBsAg positiveHCV antibody negative and HIV antibody negative; 3. HBV-DNA>200 IU/mL; 4. BCLC stagingO ? 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. CCR= 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

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.

Design outcomes

Primary

MeasureTime frame
HBsAg;HBsAb;HBeAg;HBeAb;HBcAb;interferona;interferon ß;interferon ?;

Secondary

MeasureTime frame
AFP;PIVKA-II;Abdominal ultrasound;

Countries

China

Contacts

Public ContactLi Chuan

West China Hospital, Sichuan University

lichuan@scu.edu.cn+86 18602811455

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026