RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection

NCT04032860 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 1185022016
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

HCC; HBV Coinfection

Keywords

tenofovir, HBV, HCC, nucleo(t)side analogues, Entecavir

Outcome Measures

Primary Outcomes (2)

• Overall survival

  the difference of overall survival between two groups

  1,3,5 years

• Recurrence-free survival

  the difference of overall survival between two groups

  1,3,5 years

Secondary Outcomes (2)

• cytokines

  1-3 years

• Viral reactivity

  1,3 year

Study Arms (2)

ETV group

EXPERIMENTAL

group in which patients take ETV as antiviral therapy after curative treatment

Drug: Entecavir

TDF group

EXPERIMENTAL

group in which patients take TDF as antiviral therapy after curative treatment

Drug: Tenofovir Disoproxil

Interventions

Tenofovir Disoproxil DRUG

patients with HBV-HCC would take TDF as antiviral therapy before curative treatment to see the prognosis after surgery

Also known as: TDF

TDF group

Entecavir DRUG

patients with HBV-HCC would take ETV as antiviral therapy before curative treatment to see the prognosis after surgery

Also known as: ETV

ETV group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 years and less than 69 years old;
• HBsAg positive HCV antibody negative and HIV antibody negative;
• HBV-DNA\>200 IU/mL;
• BCLC（Barcelona Clinic Liver Cancer） staging O and A stage;
• Platelet100×10\^9/L;
• Liver function Child-Pugh A,with no invasion in portal vein, hepatic vein and two large branches, no extrahepatic metastasis;
• Creatinine clearance rate≥ 70 mL/min;
• Antiviral treatment was not performed before surgery or antiviral treatment was accepted in a short term (\<3 months);
• No treatment was performed before the operation. The results of postoperatively histopathological biopsy were HCC;
• The patients agree to participate in the clinical trial.

You may not qualify if:

• 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;
• The patient combined with a malignant tumor of other organs or had a history of other malignant tumors in other organs;
• Liver function decompensation, such as: upper gastrointestinal bleeding, refractory ascites, coagulation dysfunction and so on;
• contraindications to surgery;
• Patients with poor compliance and not adhered to the follow-ups;
• Patients refused to participate in the clinical trial.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Tenofovir; entecavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• He Linye, Doctor

  Westchina Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor of liver surgery, Principal Investigator,

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 25, 2019
• Study Start: July 1, 2017
• Primary Completion: July 1, 2022
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: requestors will be required to sign a data access agreement

Locations

CN (1)