NCT04434989

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 SBRT for perivascular hepatocellular carcinoma, compared with RFA.

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
170

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable hepatocellular-carcinoma

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

June 1, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

5 years

First QC Date

June 15, 2020

Last Update Submit

June 15, 2020

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • 1-year local recurrence rate

    The rate of participants who have recurrence in treating area in 1 year to all the participants

    1 year

  • Disease-free survival

    The duration between radomization and recurrence, progression or death

    2 years

Secondary Outcomes (3)

  • Overall survival

    2 years

  • 2-year recurrence rate

    2 years

  • Adverse events

    2 years

Study Arms (2)

Stereotactic Body Radiation Therapy

EXPERIMENTAL

SBRT is defined as a special radiotherapy technique. The high dose of radiotherapy is accurately injected into the tumor lesion in one to several times using external irradiation technique. Then the tumor is exposed to high dose and the surrounding normal tissue to low dose.

Radiation: Stereotactic Body Radiation Therapy

Radiofrequency Ablation

ACTIVE COMPARATOR

Percutaneous radiofrequency ablation to the tumor

Procedure: radiofrequency ablation

Interventions

Stereotactic Body Radiation TherapyRADIATION

SBRT for perivascular HCC

Also known as: SBRT
Stereotactic Body Radiation Therapy
radiofrequency ablationPROCEDURE

RFA for perivascular HCC

Also known as: RFA
Radiofrequency Ablation

Eligibility Criteria

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

You may qualify if:

  • Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma after curative treatment.
  • Unifocal tumor ≤5cm
  • Closed to great vessels (diameter ≥3mm)
  • ECOG score 0-1
  • Child-Pugh grade A or B7
  • Sufficient liver and kidney function

You may not qualify if:

  • Vascular invasion
  • Extra-hepatic metastasis
  • Received TACE before
  • Inflammation of local skin
  • 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 (4)

  • Kang TW, Lim HK, Lee MW, Kim YS, Choi D, Rhim H. Perivascular versus nonperivascular small HCC treated with percutaneous RF ablation: retrospective comparison of long-term therapeutic outcomes. Radiology. 2014 Mar;270(3):888-99. doi: 10.1148/radiol.13130753. Epub 2013 Nov 22.

    PMID: 24475820BACKGROUND

  • Kim N, Cheng J, Jung I, Liang J, Shih YL, Huang WY, Kimura T, Lee VHF, Zeng ZC, Zhenggan R, Kay CS, Heo SJ, Won JY, Seong J. Stereotactic body radiation therapy vs. radiofrequency ablation in Asian patients with hepatocellular carcinoma. J Hepatol. 2020 Jul;73(1):121-129. doi: 10.1016/j.jhep.2020.03.005. Epub 2020 Mar 10.

    PMID: 32165253BACKGROUND

  • Wahl DR, Stenmark MH, Tao Y, Pollom EL, Caoili EM, Lawrence TS, Schipper MJ, Feng M. Outcomes After Stereotactic Body Radiotherapy or Radiofrequency Ablation for Hepatocellular Carcinoma. J Clin Oncol. 2016 Feb 10;34(5):452-9. doi: 10.1200/JCO.2015.61.4925. Epub 2015 Nov 30.

    PMID: 26628466BACKGROUND

  • Rajyaguru DJ, Borgert AJ, Smith AL, Thomes RM, Conway PD, Halfdanarson TR, Truty MJ, Kurup AN, Go RS. Radiofrequency Ablation Versus Stereotactic Body Radiotherapy for Localized Hepatocellular Carcinoma in Nonsurgically Managed Patients: Analysis of the National Cancer Database. J Clin Oncol. 2018 Feb 20;36(6):600-608. doi: 10.1200/JCO.2017.75.3228. Epub 2018 Jan 12.

    PMID: 29328861BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

RadiosurgeryRadiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative TechniquesRadiofrequency TherapyAblation Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 17, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

June 17, 2020

Record last verified: 2020-06

Locations

CN(1)