<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04434989</url>
  </required_header>
  <id_info>
    <org_study_id>HCC2020</org_study_id>
    <nct_id>NCT04434989</nct_id>
  </id_info>
  <brief_title>SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma</brief_title>
  <acronym>SAIL</acronym>
  <official_title>Stereotactic Body Radiotherapy Versus Ablation for Perivascular Hepatocellular Carcinoma: A Phase 2, Multicenter, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to&#xD;
      explore the efficacy and safety of SBRT for perivascular hepatocellular carcinoma, compared&#xD;
      with RFA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary endpoint is 1-year local recurrence rate and disease-free survival. We planned to&#xD;
      recruit 170 patients who diagnosed as perivascular hepatocellular carcinoma. The patients&#xD;
      will be randomized into SBRT group and RFA group as 1:1 ratio.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>1-year local recurrence rate</measure>
    <time_frame>1 year</time_frame>
    <description>The rate of participants who have recurrence in treating area in 1 year to all the participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>2 years</time_frame>
    <description>The duration between radomization and recurrence, progression or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>2 years</time_frame>
    <description>The duration between radomization and death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-year recurrence rate</measure>
    <time_frame>2 years</time_frame>
    <description>The rate of participants who have recurrence in 2 years to all the participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>2 years</time_frame>
    <description>The incidence rate of severe adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Stereotactic Body Radiation Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiofrequency Ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Percutaneous radiofrequency ablation to the tumor</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiation Therapy</intervention_name>
    <description>SBRT for perivascular HCC</description>
    <arm_group_label>Stereotactic Body Radiation Therapy</arm_group_label>
    <other_name>SBRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>radiofrequency ablation</intervention_name>
    <description>RFA for perivascular HCC</description>
    <arm_group_label>Radiofrequency Ablation</arm_group_label>
    <other_name>RFA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma after curative&#xD;
             treatment.&#xD;
&#xD;
          2. Unifocal tumor ≤5cm&#xD;
&#xD;
          3. Closed to great vessels (diameter ≥3mm)&#xD;
&#xD;
          4. ECOG score 0-1&#xD;
&#xD;
          5. Child-Pugh grade A or B7&#xD;
&#xD;
          6. Sufficient liver and kidney function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Vascular invasion&#xD;
&#xD;
          2. Extra-hepatic metastasis&#xD;
&#xD;
          3. Received TACE before&#xD;
&#xD;
          4. Inflammation of local skin&#xD;
&#xD;
          5. Dysfunction of liver, kidney or bone marrow.&#xD;
&#xD;
          6. Concomitant other malignant tumor or HIV infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming Kuang, MD. PhD.</last_name>
      <phone>008687755766</phone>
      <phone_ext>8576</phone_ext>
      <email>kuangm@mail.sysu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>24475820</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>32165253</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26628466</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>29328861</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Ming Kuang</investigator_full_name>
    <investigator_title>Vice President</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04434989
org study id: HCC2020
nct id: NCT04434989
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 1-year local recurrence rate
time frame: 1 year
description: The rate of participants who have recurrence in treating area in 1 year to all the participants
measure: Disease-free survival
time frame: 2 years
description: The duration between radomization and recurrence, progression or death
measure: Overall survival
time frame: 2 years
description: The duration between radomization and death
measure: 2-year recurrence rate
time frame: 2 years
description: The rate of participants who have recurrence in 2 years to all the participants
measure: Adverse events
time frame: 2 years
description: The incidence rate of severe adverse events
arm group label: Stereotactic Body Radiation Therapy
arm group type: Experimental
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 group label: Radiofrequency Ablation
arm group type: Active Comparator
description: Percutaneous radiofrequency ablation to the tumor
intervention type: Radiation
intervention name: Stereotactic Body Radiation Therapy
description: SBRT for perivascular HCC
arm group label: Stereotactic Body Radiation Therapy
other name: SBRT
intervention type: Procedure
intervention name: radiofrequency ablation
description: RFA for perivascular HCC
arm group label: Radiofrequency Ablation
other name: RFA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
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.
PMID: 24475820
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.
PMID: 32165253
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.
PMID: 26628466
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.
PMID: 29328861
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital, Sun Yat-Sen University
investigator full name: Ming Kuang
investigator title: Vice President
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular