SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma

NCT ID: NCT04434989

Last Updated: 2020-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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The primary endpoint is 1-year local recurrence rate and disease-free survival. We planned to recruit 170 patients who diagnosed as perivascular hepatocellular carcinoma. The patients will be randomized into SBRT group and RFA group as 1:1 ratio.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stereotactic Body Radiation Therapy

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.

Group Type EXPERIMENTAL

Stereotactic Body Radiation Therapy

Intervention Type RADIATION

SBRT for perivascular HCC

Radiofrequency Ablation

Percutaneous radiofrequency ablation to the tumor

Group Type ACTIVE_COMPARATOR

radiofrequency ablation

Intervention Type PROCEDURE

RFA for perivascular HCC

Interventions

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Stereotactic Body Radiation Therapy

SBRT for perivascular HCC

Intervention Type RADIATION

radiofrequency ablation

RFA for perivascular HCC

Intervention Type PROCEDURE

Other Intervention Names

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SBRT RFA

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Vascular invasion
2. Extra-hepatic metastasis
3. Received TACE before
4. Inflammation of local skin
5. Dysfunction of liver, kidney or bone marrow.
6. Concomitant other malignant tumor or HIV infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Ming Kuang

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Ming Kuang, MD. PhD.

Role: primary

008687755766 ext. 8576

References

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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.

Reference Type BACKGROUND
PMID: 24475820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32165253 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26628466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29328861 (View on PubMed)

Other Identifiers

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HCC2020

Identifier Type: -

Identifier Source: org_study_id

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