SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma (SAIL)

June 15, 2020 updated by: Ming Kuang, Sun Yat-sen University

Stereotactic Body Radiotherapy Versus Ablation for Perivascular Hepatocellular Carcinoma: A Phase 2, Multicenter, Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Radiation: Stereotactic Body Radiation Therapy
SBRT for perivascular HCC
Other Names:
  • SBRT
Active Comparator: Radiofrequency Ablation
Percutaneous radiofrequency ablation to the tumor
Procedure: radiofrequency ablation
RFA for perivascular HCC
Other Names:
  • RFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year local recurrence rate
Time Frame: 1 year
The rate of participants who have recurrence in treating area in 1 year to all the participants
1 year
Disease-free survival
Time Frame: 2 years
The duration between radomization and recurrence, progression or death
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 17, 2020

Study Record Updates

Last Update Posted (Actual)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 15, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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