<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/NCT02192671</url>
  </required_header>
  <id_info>
    <org_study_id>HRRFA-HCC/PHT</org_study_id>
    <secondary_id>HRRFA-HCC/PHT</secondary_id>
    <nct_id>NCT02192671</nct_id>
  </id_info>
  <brief_title>HR Versus RFA for HCC in Patients With PHT</brief_title>
  <acronym>HR-HCC/PHT</acronym>
  <official_title>Hepatic Resection Versus Radiofrequency Ablation for Patients With Hepatocellular Carcinoma and Portal Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangxi Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangxi Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the investigators' study is to prospectively compare the safety and efficacy&#xD;
      of hepatic resection to radiofrequency ablation for hepatocellular carcinoma in patients with&#xD;
      portal hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cirrhosis is common among patients with hepatocellular carcinoma (HCC); in China, for&#xD;
      example, it occurs in approximately 80% of HCC patients. Another common comorbidity of HCC is&#xD;
      clinically significant portal hypertension (PHT), which occurs in 25-55% of patients with&#xD;
      both HCC and cirrhosis. PHT correlates with the severity of cirrhosis, and it can complicate&#xD;
      HCC treatment by increasing the risk of perioperative hemorrhage and liver failure.&#xD;
&#xD;
      Hepatic resection (HR) is a widely used radical therapy for HCC. Although HR is often&#xD;
      suitable for HCC patients with cirrhosis, it is widely regarded as unsuitable for HCC&#xD;
      patients with PHT because of the potential for postoperative hepatic decompensation. In fact,&#xD;
      the absence of PHT is the best predictor of excellent HR outcomes. Guidelines of the American&#xD;
      and European Associations for the Study of Liver Disease do not recommend HR as an option for&#xD;
      HCC patients with PHT. Several studies, however, have reported that HCC patients with and&#xD;
      without clinically significant PHT showed similar short- and long-term outcomes after HR.&#xD;
      This controversy is important to resolve because more than 25% of cirrhotic patients with HCC&#xD;
      also present with PHT.&#xD;
&#xD;
      Actually, official guidelines recommend liver transplatation for patients with HCC and PHT.&#xD;
      However, implementation of liver transplantation is restricted by the lack of liver donation&#xD;
      and the high cost of the procedure in many countries, especially China. However, as a&#xD;
      minimally invasive therapy, radiofrequency ablation (RFA) is a popular treatment modality for&#xD;
      patients with HCC within Milan Criteria. Moreover, randomized controlled trials have&#xD;
      validated and proposed its clinical usage.&#xD;
&#xD;
      So here, we plan to address the safety and efficacy of HR comparing with RFA for HCC patients&#xD;
      with PHT using a population from Guangxi province of China, where the population shows the&#xD;
      highest HCC incidence in the world.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2022</primary_completion_date>
  <phase>Phase 3</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>Overall survival</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital mortality</measure>
    <time_frame>90 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence rate</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Carcinoma, Hepatocellular</condition>
  <condition>Liver Neoplasms</condition>
  <condition>Neoplasms, Glandular and Epithelial</condition>
  <arm_group>
    <arm_group_label>Hepatic resection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adequate remnant liver volume was 30% for HCC patients without cirrhosis, and &gt;50% for HCC patients with chronic hepatitis, cirrhosis, or severe fatty liver.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiofrequency ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>RFA is performed in less than one week after clinical diagnosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hepatic Resection</intervention_name>
    <description>Indications for HR are the presence of appropriate residual liver volume determined by volumetric computed tomography.</description>
    <arm_group_label>Hepatic resection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radiofrequency Ablation</intervention_name>
    <arm_group_label>Radiofrequency ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-75 years&#xD;
&#xD;
          -  In the HR group, clinical diagnosis of HCC was confirmed by histopathological&#xD;
             examination of surgical samples in all patients; in the RFA group, HCC diagnosis was&#xD;
             confirmed by two types of clinical imaging (ultrasonography, computed tomography, or&#xD;
             magnetic resonance imaging), togetherwith a serum level of α-fetoprotein higher than&#xD;
             400 ng/mL. If diagnosis based on imaging andα-fetoprotein level was uncertain, needle&#xD;
             biopsy was performed.&#xD;
&#xD;
          -  Tumor stage fitted into Milan Criteria&#xD;
&#xD;
          -  Patients with clinically relevant portal hypertension, which is defined as the&#xD;
             presence of esophageal varices and/or a platelet count of less than 100 000 per μL in&#xD;
             association with splenomegaly.&#xD;
&#xD;
          -  Patients have Child-Pugh A or B liver function&#xD;
&#xD;
          -  No previous neoadjuvant treatment&#xD;
&#xD;
          -  No evidence of metastasis to the lymph nodes and/or distant metastases on the basis of&#xD;
             preoperative imaging results and perioperative findings&#xD;
&#xD;
          -  No malignancy other than HCC for 5 years prior to the initial HCC treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cardiac disease&#xD;
&#xD;
          -  Known history of human immunodeficiency virus (HIV) infection&#xD;
&#xD;
          -  Known Central Nervous System tumors including metastatic brain disease&#xD;
&#xD;
          -  History of organ allograft&#xD;
&#xD;
          -  Substance abuse, medical, psychological or social conditions that may interfere with&#xD;
             the patient's participation in the study or evaluation of the study results&#xD;
&#xD;
          -  Any condition that is unstable or which could jeopardize the safety of the patient and&#xD;
             his/her compliance in the study&#xD;
&#xD;
          -  Pregnant or breast-feeding patients.&#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_contact>
    <last_name>Jian-Hong Zhong, MD</last_name>
    <phone>86-771-5330855</phone>
    <email>zhongjianhong66@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian-Hong Zhong, MD</last_name>
      <phone>86-771-5330855</phone>
      <email>zhongjianhong66@163.com</email>
    </contact>
    <investigator>
      <last_name>Jian-Hong Zhong, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>January 14, 2022</last_update_submitted>
  <last_update_submitted_qc>January 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangxi Medical University</investigator_affiliation>
    <investigator_full_name>Jian-Hong Zhong</investigator_full_name>
    <investigator_title>Affiliated Tumor Hospital</investigator_title>
  </responsible_party>
  <keyword>hepatocellular carcinoma</keyword>
  <keyword>radiofrequency ablation</keyword>
  <keyword>hepatic resection</keyword>
  <keyword>portal hypertension</keyword>
  <keyword>Milan criteria</keyword>
  <keyword>randomized critical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Liver Neoplasms</mesh_term>
    <mesh_term>Neoplasms, Glandular and Epithelial</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/NCT02192671
org study id: HRRFA-HCC/PHT
secondary id: HRRFA-HCC/PHT
nct id: NCT02192671
lead sponsor: 
has dmc: No
The purpose of the investigators' study is to prospectively compare the safety and efficacy
      of hepatic resection to radiofrequency ablation for hepatocellular carcinoma in patients with
      portal hypertension.
Cirrhosis is common among patients with hepatocellular carcinoma (HCC); in China, for
      example, it occurs in approximately 80% of HCC patients. Another common comorbidity of HCC is
      clinically significant portal hypertension (PHT), which occurs in 25-55% of patients with
      both HCC and cirrhosis. PHT correlates with the severity of cirrhosis, and it can complicate
      HCC treatment by increasing the risk of perioperative hemorrhage and liver failure.

      Hepatic resection (HR) is a widely used radical therapy for HCC. Although HR is often
      suitable for HCC patients with cirrhosis, it is widely regarded as unsuitable for HCC
      patients with PHT because of the potential for postoperative hepatic decompensation. In fact,
      the absence of PHT is the best predictor of excellent HR outcomes. Guidelines of the American
      and European Associations for the Study of Liver Disease do not recommend HR as an option for
      HCC patients with PHT. Several studies, however, have reported that HCC patients with and
      without clinically significant PHT showed similar short- and long-term outcomes after HR.
      This controversy is important to resolve because more than 25% of cirrhotic patients with HCC
      also present with PHT.

      Actually, official guidelines recommend liver transplatation for patients with HCC and PHT.
      However, implementation of liver transplantation is restricted by the lack of liver donation
      and the high cost of the procedure in many countries, especially China. However, as a
      minimally invasive therapy, radiofrequency ablation (RFA) is a popular treatment modality for
      patients with HCC within Milan Criteria. Moreover, randomized controlled trials have
      validated and proposed its clinical usage.

      So here, we plan to address the safety and efficacy of HR comparing with RFA for HCC patients
      with PHT using a population from Guangxi province of China, where the population shows the
      highest HCC incidence in the world.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: 3 years
measure: Hospital mortality
time frame: 90 day
measure: Recurrence rate
time frame: 3 years
arm group label: Hepatic resection
arm group type: Experimental
description: Adequate remnant liver volume was 30% for HCC patients without cirrhosis, and >50% for HCC patients with chronic hepatitis, cirrhosis, or severe fatty liver.
arm group label: Radiofrequency ablation
arm group type: Active Comparator
description: RFA is performed in less than one week after clinical diagnosis.
intervention type: Procedure
intervention name: Hepatic Resection
description: Indications for HR are the presence of appropriate residual liver volume determined by volumetric computed tomography.
arm group label: Hepatic resection
intervention type: Procedure
intervention name: Radiofrequency Ablation
arm group label: Radiofrequency ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jian-Hong Zhong, MD
phone: 86-771-5330855
email: zhongjianhong66@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangxi Medical University
investigator full name: Jian-Hong Zhong
investigator title: Affiliated Tumor Hospital
mesh term: Carcinoma
mesh term: Neoplasms
mesh term: Carcinoma, Hepatocellular
mesh term: Liver Neoplasms
mesh term: Neoplasms, Glandular and Epithelial