NCT04392700

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
706

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2024

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

May 14, 2020

Last Update Submit

May 18, 2020

Conditions

Hepatocellular Carcinoma Recurrent

Keywords

antiviral therapy; hepatocellular carcinoma; prognosis

Outcome Measures

Primary Outcomes (1)

  • Recurrence of HCC

    radiologic evidence of tumor recurrence（CT or MRI ） at any time during the following time after liver resection

    36 months

Secondary Outcomes (1)

  • The number of overall patients

    36 months

Study Arms (2)

group A

EXPERIMENTAL

drugs：tenofovir disoproxil fumarate, dose：300mg/d

Drug: Tenofovir disoproxil fumarate 300mg

group B

ACTIVE COMPARATOR

drugs：entecavir dose： 0.5 mg/d

Drug: Entecavir 0.5 mg

Interventions

Tenofovir disoproxil fumarate 300mgDRUG

Take the medicine once a day ，300mg/d

Also known as: Fu Ma Suan Ti Nuo Fu Wei Er Bi Fu Zhi Pian
group A
Entecavir 0.5 mgDRUG

Take the medicine once a day，0.5 mg/d

Also known as: EnTiKaWeiPian(BoLuDing)
group B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 : 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

You may not qualify if:

  • 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 began：Myocardial infarction、 Unstable angina、Coronary artery bypass surgery、Cerebrovascular 、 Pulmonary embolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Tenofovirentecavir

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Li Xu

CONTACT

86-20-87343115zhouzhg@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 19, 2020

Study Start

July 25, 2019

Primary Completion

July 25, 2021

Study Completion

July 25, 2024

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations

CN(1)