<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/NCT03026452</url>
  </required_header>
  <id_info>
    <org_study_id>RFA-001</org_study_id>
    <nct_id>NCT03026452</nct_id>
  </id_info>
  <brief_title>Effectivity and Safety of Ultrasound-guided Percutaneously Radiofrequency Ablation for Liver Cancer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital of Zhejiang University</source>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of ultrasonography (US) -guided radiofrequency ablation&#xD;
      for liver tumors, the investigators used preoperative and postoperative&#xD;
      US/CEUS(contrast-enhanced ultrasonography)/CT/MRI to assess lesions, and laboratory tests&#xD;
      including the tumor markers to evaluate the general condition of patients. Intraoperative&#xD;
      US/CEUS/CT would be applied to monitor ablation lesions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor size assessed by MRI</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>Tumor size was estimated by MRI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Carcinoembryonic Antigen (CEA) level assessed by ELISA</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>CEA level was assessed by enzyme linked immunosorbent assay (ELISA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alpha Fetoprotein (AFP) level assessed by ELISA</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>AFP level was assessed by ELISA.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Liver Cancer</condition>
  <arm_group>
    <arm_group_label>RFA(radiofrequency ablation)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The investigators used percutaneously US-guided RFA(radiofrequency ablation) for small hepatocellular carcinoma,and estimated the safety and efficacy of this treatment through 2-year follow-up of US/CEUS/CT/MRI and the tumor markers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>US-guided RFA</intervention_name>
    <description>The investigators used percutaneously US-guided radiofrequency ablation for patients with small hepatocellular carcinoma,and estimated the safety and efficacy of this treatment through 2-year follow-up of US/CEUS/CT/MRI and the tumor markers.</description>
    <arm_group_label>RFA(radiofrequency ablation)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with small hepatocellular carcinoma (single or multiple nodules of less than&#xD;
             3 cm in diameter), Patients with Child-Pugh A/B, Patients with PLT(platelet count) ≥&#xD;
             50*10e9/L and PT(prothrombin time) ≤ 20s.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with blood coagulation dysfunction, ChildPugh score≥3, severe cardiopulmonary&#xD;
             disease, intolerant anesthesia and upper gastrointestinal bleeding in shock.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tian'an Jiang, Phd</last_name>
      <phone>+86 18857127666</phone>
      <email>tiananjiang@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Guo Tian, Master</last_name>
      <phone>+86 13600529967</phone>
      <email>871035504@qq.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Sasaki K, Margonis GA, Andreatos N, Kim Y, Wilson A, Gani F, Amini N, Pawlik TM. Combined resection and RFA in colorectal liver metastases: stratification of long-term outcomes. J Surg Res. 2016 Nov;206(1):182-189. doi: 10.1016/j.jss.2016.06.098. Epub 2016 Jul 4.</citation>
    <PMID>27916360</PMID>
  </results_reference>
  <results_reference>
    <citation>Giorgio A, Merola MG, Montesarchio L, Merola F, Santoro B, Coppola C, Gatti P, Amendola F, DI Sarno A, Calvanese A, Matteucci P, Giorgio V. Sorafenib Combined with Radio-frequency Ablation Compared with Sorafenib Alone in Treatment of Hepatocellular Carcinoma Invading Portal Vein: A Western Randomized Controlled Trial. Anticancer Res. 2016 Nov;36(11):6179-6183. doi: 10.21873/anticanres.11211.</citation>
    <PMID>27793949</PMID>
  </results_reference>
  <results_reference>
    <citation>Makino Y, Imai Y, Igura T, Kogita S, Sawai Y, Fukuda K, Iwamoto T, Okabe J, Takamura M, Fujita N, Hori M, Takehara T, Kudo M, Murakami T. Feasibility of Extracted-Overlay Fusion Imaging for Intraoperative Treatment Evaluation of Radiofrequency Ablation for Hepatocellular Carcinoma. Liver Cancer. 2016 Oct;5(4):269-279. doi: 10.1159/000449338. Epub 2016 Sep 14.</citation>
    <PMID>27781199</PMID>
  </results_reference>
  <results_reference>
    <citation>Aissou S, Cartier V, Hamy A, Plumereau F, Aube C, Lermite E. Radiofrequency in the Management of Colorectal Liver Metastases: A 10-Year Experience at a Single Center. Surg Technol Int. 2016 Oct 26;29:99-105.</citation>
    <PMID>27780345</PMID>
  </results_reference>
  <results_reference>
    <citation>Barat M, Fohlen A, Cassinotto C, Jannot AS, Dautry R, Pelage JP, Boudiaf M, Pocard M, Eveno C, Taouli B, Soyer P, Dohan A. One-month apparent diffusion coefficient correlates with response to radiofrequency ablation of hepatocellular carcinoma. J Magn Reson Imaging. 2017 Jun;45(6):1648-1658. doi: 10.1002/jmri.25521. Epub 2016 Oct 20.</citation>
    <PMID>27766709</PMID>
  </results_reference>
  <results_reference>
    <citation>Seror O, N'Kontchou G, Nault JC, Rabahi Y, Nahon P, Ganne-Carrie N, Grando V, Zentar N, Beaugrand M, Trinchet JC, Diallo A, Sellier N. Hepatocellular Carcinoma within Milan Criteria: No-Touch Multibipolar Radiofrequency Ablation for Treatment-Long-term Results. Radiology. 2016 Aug;280(2):611-21. doi: 10.1148/radiol.2016150743. Epub 2016 Mar 24. Erratum In: Radiology. 2016 Sep;280(3):981.</citation>
    <PMID>27010381</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>July 26, 2018</last_update_submitted>
  <last_update_submitted_qc>July 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</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/NCT03026452
org study id: RFA-001
nct id: NCT03026452
lead sponsor: 
To evaluate the safety and efficacy of ultrasonography (US) -guided radiofrequency ablation
      for liver tumors, the investigators used preoperative and postoperative
      US/CEUS(contrast-enhanced ultrasonography)/CT/MRI to assess lesions, and laboratory tests
      including the tumor markers to evaluate the general condition of patients. Intraoperative
      US/CEUS/CT would be applied to monitor ablation lesions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tumor size assessed by MRI
time frame: through study completion, an average of 2 year
description: Tumor size was estimated by MRI.
measure: Carcinoembryonic Antigen (CEA) level assessed by ELISA
time frame: through study completion, an average of 2 year
description: CEA level was assessed by enzyme linked immunosorbent assay (ELISA).
measure: Alpha Fetoprotein (AFP) level assessed by ELISA
time frame: through study completion, an average of 2 year
description: AFP level was assessed by ELISA.
arm group label: RFA(radiofrequency ablation)
arm group type: Experimental
description: The investigators used percutaneously US-guided RFA(radiofrequency ablation) for small hepatocellular carcinoma,and estimated the safety and efficacy of this treatment through 2-year follow-up of US/CEUS/CT/MRI and the tumor markers.
intervention type: Procedure
intervention name: US-guided RFA
description: The investigators used percutaneously US-guided radiofrequency ablation for patients with small hepatocellular carcinoma,and estimated the safety and efficacy of this treatment through 2-year follow-up of US/CEUS/CT/MRI and the tumor markers.
arm group label: RFA(radiofrequency ablation)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
citation: Sasaki K, Margonis GA, Andreatos N, Kim Y, Wilson A, Gani F, Amini N, Pawlik TM. Combined resection and RFA in colorectal liver metastases: stratification of long-term outcomes. J Surg Res. 2016 Nov;206(1):182-189. doi: 10.1016/j.jss.2016.06.098. Epub 2016 Jul 4.
PMID: 27916360
citation: Giorgio A, Merola MG, Montesarchio L, Merola F, Santoro B, Coppola C, Gatti P, Amendola F, DI Sarno A, Calvanese A, Matteucci P, Giorgio V. Sorafenib Combined with Radio-frequency Ablation Compared with Sorafenib Alone in Treatment of Hepatocellular Carcinoma Invading Portal Vein: A Western Randomized Controlled Trial. Anticancer Res. 2016 Nov;36(11):6179-6183. doi: 10.21873/anticanres.11211.
PMID: 27793949
citation: Makino Y, Imai Y, Igura T, Kogita S, Sawai Y, Fukuda K, Iwamoto T, Okabe J, Takamura M, Fujita N, Hori M, Takehara T, Kudo M, Murakami T. Feasibility of Extracted-Overlay Fusion Imaging for Intraoperative Treatment Evaluation of Radiofrequency Ablation for Hepatocellular Carcinoma. Liver Cancer. 2016 Oct;5(4):269-279. doi: 10.1159/000449338. Epub 2016 Sep 14.
PMID: 27781199
citation: Aissou S, Cartier V, Hamy A, Plumereau F, Aube C, Lermite E. Radiofrequency in the Management of Colorectal Liver Metastases: A 10-Year Experience at a Single Center. Surg Technol Int. 2016 Oct 26;29:99-105.
PMID: 27780345
citation: Barat M, Fohlen A, Cassinotto C, Jannot AS, Dautry R, Pelage JP, Boudiaf M, Pocard M, Eveno C, Taouli B, Soyer P, Dohan A. One-month apparent diffusion coefficient correlates with response to radiofrequency ablation of hepatocellular carcinoma. J Magn Reson Imaging. 2017 Jun;45(6):1648-1658. doi: 10.1002/jmri.25521. Epub 2016 Oct 20.
PMID: 27766709
citation: Seror O, N'Kontchou G, Nault JC, Rabahi Y, Nahon P, Ganne-Carrie N, Grando V, Zentar N, Beaugrand M, Trinchet JC, Diallo A, Sellier N. Hepatocellular Carcinoma within Milan Criteria: No-Touch Multibipolar Radiofrequency Ablation for Treatment-Long-term Results. Radiology. 2016 Aug;280(2):611-21. doi: 10.1148/radiol.2016150743. Epub 2016 Mar 24. Erratum In: Radiology. 2016 Sep;280(3):981.
PMID: 27010381
responsible party type: Sponsor
mesh term: Liver Neoplasms