<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/NCT03790059</url>
  </required_header>
  <id_info>
    <org_study_id>SWH2016LCYB-11</org_study_id>
    <nct_id>NCT03790059</nct_id>
  </id_info>
  <brief_title>Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma.</brief_title>
  <official_title>Radiofrequency Ablation Combined With Local Injection of Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma:A Multicenter Prospective Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southwest Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southwest Hospital, China</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>
      The primary reason for recurrence of hepatocellular carcinoma after radiofrequency ablation&#xD;
      (RFA) is the micro-metastatic lesion that has not been ablated and inactivated in the&#xD;
      transitional area.Some clinical trials have confirmed that H101(recombinant human adenovirus&#xD;
      type 5 injection) has selective oncolysis in a variety of solid tumors.However, there are no&#xD;
      reports that H101 which is injected during surgery can improve the efficacy of RFA in liver&#xD;
      cancer at present.Therefore,We used a multicenter prospective randomized controlled study as&#xD;
      the main method to prospectively compare the short-term and long-term efficacy of RFA&#xD;
      combined with H101 group and traditional RFA group in the treatment of small liver cancer&#xD;
      (single lesion , diameter less than or equal to 3cm，to evaluate the value of RFA combined&#xD;
      with H101 injection in reducing the postoperative recurrence rate of small hepatocellular&#xD;
      carcinoma, and to provide a reliable evidence-based medical basis for the selection of&#xD;
      treatment methods for small hepatocellular carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary reason for recurrence of hepatocellular carcinoma after radiofrequency ablation&#xD;
      (RFA) is the micro-metastatic lesion that has not been ablated and inactivated in the&#xD;
      transitional area.Oncolytic virus H101 is a genetically engineered adenovirus that lacks Elb&#xD;
      55ku protein.Some clinical trials have confirmed that H101 has selective oncolysis in a&#xD;
      variety of solid tumors.Furthermore,research shows that the directly dissolving tumor&#xD;
      activity of H101 enhanced obviously and activate the body's anti-tumor immune to induce the&#xD;
      distal antitumor effect under the condition of mild high temperature (40 ℃ and 42 ℃).The&#xD;
      transition zone of RFA can provide the appropriate mild high temperature.However, there are&#xD;
      no reports that H101 which is injected during surgery can improve the efficacy of RFA in&#xD;
      liver cancer at present.Therefore,We used a multicenter prospective randomized controlled&#xD;
      study as the main method to prospectively compare the short-term and long-term efficacy of&#xD;
      RFA combined with H101 group and traditional RFA group in the treatment of small liver cancer&#xD;
      (single lesion , diameter less than or equal to 3cm，to evaluate the value of RFA combined&#xD;
      with H101 injection in reducing the postoperative recurrence rate of small hepatocellular&#xD;
      carcinoma, and to provide a reliable evidence-based medical basis for the selection of&#xD;
      treatment methods for small hepatocellular carcinoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>Tumor-free survival</measure>
    <time_frame>two-years tumor-free survival.</time_frame>
    <description>Postoperative tumor-free survival is an evaluation of tumor recurrence and metastasis.It's also an evaluation of the efficacy of the experimental group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>two-years overall survival.</time_frame>
    <description>The percentage of patients who receive certain treatments and are still alive after years of follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>RFA combined with H101 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group was RFA combined H101.H101 has oncolysis in HCC after RFA and reduce tumor recurrence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional RFA group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The standard control group was the conventional RFA.Using RFA for the treatment of small HCC.The efficacy was compared with that of the experimental group combined with H101.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>H101</intervention_name>
    <description>Intraoperative injection of H101 can improve the efficacy of RFA in hepatocellular carcinoma.</description>
    <arm_group_label>RFA combined with H101 group</arm_group_label>
    <other_name>Recombinant Human Adenovirus Type 5 Injection（H101）.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RFA</intervention_name>
    <description>Treat the samll HCC with the RFA.</description>
    <arm_group_label>Conventional RFA group</arm_group_label>
    <arm_group_label>RFA combined with H101 group</arm_group_label>
    <other_name>Radiofrequency ablation（RFA）.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patients understand the content and significance of the study and we obtain a&#xD;
             written informed consent from them.&#xD;
&#xD;
          2. The patients' gender are not limited and are between the ages of 18 and 75.&#xD;
&#xD;
          3. Liver function of Child-Pugh Class A or B;The retention rate of indocyanine green for&#xD;
             15 minutes is less than or equal to 20%.&#xD;
&#xD;
          4. The ECOG score is 0.&#xD;
&#xD;
          5. The diagnosis was a single hepatocellular carcinoma with a diameter of no more than&#xD;
             3cm.&#xD;
&#xD;
          6. There were no other related diseases affecting RFA treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. There are tumor emboli in the large vessels of the liver;distant metastasis of HCC.&#xD;
&#xD;
          2. The patient has or has had a history of refractory ascites,hepatic encephalopathy, or&#xD;
             esophageal varices hemorrhage.&#xD;
&#xD;
          3. The patient was complicated with other malignant tumors.&#xD;
&#xD;
          4. The patient has severe cardiac, renal and other organ dysfunction.&#xD;
&#xD;
          5. In addition to viral hepatitis, there are other active infectious diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kuansheng Ma, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Institute of hepatobiliary surgery,Southwest Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kai Feng, M.D</last_name>
    <phone>+86-23-13228683383</phone>
    <email>fengkai7688@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of hepatobiliary surgery,Southwest Hospital</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kai Feng, M.D</last_name>
      <phone>+86-23-13228683383</phone>
      <email>fengkai7688@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Kai Feng, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institute of hepatobiliary surgery,Southwest Hospital</name>
      <address>
        <city>Chongqing</city>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kai Feng, M.D</last_name>
      <phone>+86-23-13228683383</phone>
      <email>fengkai7688@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>October 15, 2019</last_update_submitted>
  <last_update_submitted_qc>October 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southwest Hospital, China</investigator_affiliation>
    <investigator_full_name>fengkai</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>radiofrequency ablation</keyword>
  <keyword>hepatocellular carcinoma</keyword>
  <keyword>recombinant human adenovirus type 5 injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoviridae Infections</mesh_term>
    <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/NCT03790059
org study id: SWH2016LCYB-11
nct id: NCT03790059
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary reason for recurrence of hepatocellular carcinoma after radiofrequency ablation
      (RFA) is the micro-metastatic lesion that has not been ablated and inactivated in the
      transitional area.Some clinical trials have confirmed that H101(recombinant human adenovirus
      type 5 injection) has selective oncolysis in a variety of solid tumors.However, there are no
      reports that H101 which is injected during surgery can improve the efficacy of RFA in liver
      cancer at present.Therefore,We used a multicenter prospective randomized controlled study as
      the main method to prospectively compare the short-term and long-term efficacy of RFA
      combined with H101 group and traditional RFA group in the treatment of small liver cancer
      (single lesion , diameter less than or equal to 3cm，to evaluate the value of RFA combined
      with H101 injection in reducing the postoperative recurrence rate of small hepatocellular
      carcinoma, and to provide a reliable evidence-based medical basis for the selection of
      treatment methods for small hepatocellular carcinoma.
The primary reason for recurrence of hepatocellular carcinoma after radiofrequency ablation
      (RFA) is the micro-metastatic lesion that has not been ablated and inactivated in the
      transitional area.Oncolytic virus H101 is a genetically engineered adenovirus that lacks Elb
      55ku protein.Some clinical trials have confirmed that H101 has selective oncolysis in a
      variety of solid tumors.Furthermore,research shows that the directly dissolving tumor
      activity of H101 enhanced obviously and activate the body's anti-tumor immune to induce the
      distal antitumor effect under the condition of mild high temperature (40 ℃ and 42 ℃).The
      transition zone of RFA can provide the appropriate mild high temperature.However, there are
      no reports that H101 which is injected during surgery can improve the efficacy of RFA in
      liver cancer at present.Therefore,We used a multicenter prospective randomized controlled
      study as the main method to prospectively compare the short-term and long-term efficacy of
      RFA combined with H101 group and traditional RFA group in the treatment of small liver cancer
      (single lesion , diameter less than or equal to 3cm，to evaluate the value of RFA combined
      with H101 injection in reducing the postoperative recurrence rate of small hepatocellular
      carcinoma, and to provide a reliable evidence-based medical basis for the selection of
      treatment methods for small hepatocellular carcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tumor-free survival
time frame: two-years tumor-free survival.
description: Postoperative tumor-free survival is an evaluation of tumor recurrence and metastasis.It's also an evaluation of the efficacy of the experimental group
measure: Overall survival
time frame: two-years overall survival.
description: The percentage of patients who receive certain treatments and are still alive after years of follow-up.
arm group label: RFA combined with H101 group
arm group type: Experimental
description: The experimental group was RFA combined H101.H101 has oncolysis in HCC after RFA and reduce tumor recurrence.
arm group label: Conventional RFA group
arm group type: Other
description: The standard control group was the conventional RFA.Using RFA for the treatment of small HCC.The efficacy was compared with that of the experimental group combined with H101.
intervention type: Drug
intervention name: H101
description: Intraoperative injection of H101 can improve the efficacy of RFA in hepatocellular carcinoma.
arm group label: RFA combined with H101 group
other name: Recombinant Human Adenovirus Type 5 Injection（H101）.
intervention type: Procedure
intervention name: RFA
description: Treat the samll HCC with the RFA.
arm group label: Conventional RFA group
arm group label: RFA combined with H101 group
other name: Radiofrequency ablation（RFA）.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Kuansheng Ma, Ph.D
role: Study Director
affiliation: Institute of hepatobiliary surgery,Southwest Hospital
last name: Kai Feng, M.D
phone: +86-23-13228683383
email: fengkai7688@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southwest Hospital, China
investigator full name: fengkai
investigator title: Principal Investigator
mesh term: Adenoviridae Infections
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular