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SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma (SAIL)

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy
radiofrequency ablation
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stereotactic Body Radiation Therapy

Radiofrequency Ablation

Arm Description

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.

Percutaneous radiofrequency ablation to the tumor

Outcomes

Primary Outcome Measures

1-year local recurrence rate
The rate of participants who have recurrence in treating area in 1 year to all the participants
Disease-free survival
The duration between radomization and recurrence, progression or death

Secondary Outcome Measures

Overall survival
The duration between radomization and death
2-year recurrence rate
The rate of participants who have recurrence in 2 years to all the participants
Adverse events
The incidence rate of severe adverse events

Full Information

First Posted
June 15, 2020
Last Updated
June 15, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04434989
Brief Title
SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma
Acronym
SAIL
Official Title
Stereotactic Body Radiotherapy Versus Ablation for Perivascular Hepatocellular Carcinoma: A Phase 2, Multicenter, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Body Radiation Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Radiofrequency Ablation
Arm Type
Active Comparator
Arm Description
Percutaneous radiofrequency ablation to the tumor
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SBRT
Intervention Description
SBRT for perivascular HCC
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Other Intervention Name(s)
RFA
Intervention Description
RFA for perivascular HCC
Primary Outcome Measure Information:
Title
1-year local recurrence rate
Description
The rate of participants who have recurrence in treating area in 1 year to all the participants
Time Frame
1 year
Title
Disease-free survival
Description
The duration between radomization and recurrence, progression or death
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
The duration between radomization and death
Time Frame
2 years
Title
2-year recurrence rate
Description
The rate of participants who have recurrence in 2 years to all the participants
Time Frame
2 years
Title
Adverse events
Description
The incidence rate of severe adverse events
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Kuang, MD. PhD.
Phone
008687755766
Ext
8576
Email
kuangm@mail.sysu.edu.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
24475820
Citation
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.
Results Reference
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PubMed Identifier
32165253
Citation
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. Erratum In: J Hepatol. 2020 Nov;73(5):1295-1296.
Results Reference
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PubMed Identifier
26628466
Citation
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.
Results Reference
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PubMed Identifier
29328861
Citation
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.
Results Reference
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SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma

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