NCT04143191

Brief Summary

This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of Sorafenib combined with transarterial chemoembolization as adjuvant treatment for resectable advanced hepatocellular carcinoma, compared with Sorafenib alone. The primary endpoint is recurrence-free survival. This trial planned to recruit 158 patients who received curative hepatic resection with resectable advanced hepatocellular carcinoma. The patients will be randomized into Sorafenib group and Sorafenib+TACE group as 1:1 ratio.

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
158

participants targeted

Target at below P25 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Sep 2019

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

September 15, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

October 26, 2019

Last Update Submit

March 23, 2020

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free survival

    Recurrence-free survival indicates the interval between randomization and tumor recurrence or death.\[0-2 years\] Longer RFS time indicates better prognosis.

    2 years

Secondary Outcomes (4)

  • Overall survival

    2 years

  • Time to recurrence

    2 years

  • Severe adverse events

    2 years

  • Quality of life

    2 years

Study Arms (2)

Sorafenib

ACTIVE COMPARATOR

Patients in this arm will take Sorafenib orally with the dose of 400mg bid on the third day after randomization till recurrence or the end of this trial. If any drug related adverse event occurred, the dosage will be reduced.

Drug: Sorafenib

Sorafenib plus TACE

EXPERIMENTAL

Patients in this arm will take Sorafenib orally with the dose of 400mg bid on the third day after randomization till recurrence or the end of this trial. TACE will be performed on the fourth day after randomization. If any drug related adverse event occurred, the dosage will be reduced.

Drug: SorafenibProcedure: Transarterial chemoembolization

Interventions

SorafenibDRUG

Sorafenib is one of tyrosine kinase inhibitors. The initial dosage is 400mg orally, twice daily.

SorafenibSorafenib plus TACE
Transarterial chemoembolizationPROCEDURE

TACE including conventional TACE (cTACE) and DEB-TACE. Treatment choices are according to the specific condition of each patient and the experience of interventional radiologists.

Also known as: TACE
Sorafenib plus TACE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary hepatocellular carcinoma without any treatments.
  • Received curative hepatic resection
  • ECOG score 0-1
  • Child-Pugh grade A
  • Sufficient liver and kidney function

You may not qualify if:

  • Diffused lesions; tumor thrombosis in SMV or IVC.
  • Extra-hepatic metastasis.
  • Contraindication of TACE, like portal-systemic shunt, obvious atherosclerosis, etc.
  • Allergic to the contrast agent of TACE
  • Dysfunction of liver, kidney or bone marrow.
  • Concomitant other malignant tumor or HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (1)

  • Peng Z, Fan W, Liu Z, Xiao H, Wu J, Tang R, Tu J, Qiao L, Huang F, Xie W, Zhuang W, Guo W, Li S, Hua Y, Shen S, He Q, Li D, Li J, Kuang M. Adjuvant Transarterial Chemoembolization With Sorafenib for Portal Vein Tumor Thrombus: A Randomized Clinical Trial. JAMA Surg. 2024 Jun 1;159(6):616-624. doi: 10.1001/jamasurg.2024.0506.

    PMID: 38568599DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Ming Kuang, MD, PhD.

CONTACT

008687755766kuangm@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-president

Study Record Dates

First Submitted

October 26, 2019

First Posted

October 29, 2019

Study Start

September 15, 2019

Primary Completion

September 15, 2021

Study Completion

September 15, 2023

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)