<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/NCT03277716</url>
  </required_header>
  <id_info>
    <org_study_id>sysucc01</org_study_id>
    <nct_id>NCT03277716</nct_id>
  </id_info>
  <brief_title>Microwave Ablation Combined With TACE in the Treatment of Unresectable Huge Hepatocellular Carcinoma Huge</brief_title>
  <official_title>Effectivity and Safety of Microwave Ablation Combined With Transcatheter Arterial Chemoembolization(TACE) for Huge Unresectable Hepatocellular Carcinoma: a Multicenter Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fan Weijun</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>
      The purpose of this study was to prospectively evaluate the efficacy and safety of TACE&#xD;
      combined with MWA in patients with huge unresectable hepatocellular carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide. Despite the&#xD;
      widespread application of surveillance programs in high-risk populations, patients continue&#xD;
      to present with huge (≥ 10 cm) HCCs.And it's still a challenge to treat huge HCC&#xD;
      nowadays.Surgical resection is currently the only curative treatment for huge HCCs ; however,&#xD;
      only a minority of patients are candidates for curative resection. Sorafenib is recommended&#xD;
      for the treatment of advanced HCCs, including huge HCCs, but the usage is severely limited by&#xD;
      high adverse event rates and low efficiency. Thus, transarterial chemoembolization (TACE) is&#xD;
      considered the first choice for huge unresectable HCCs. Several studies have concluded that&#xD;
      TACE effectively improves the overall survival of patients with huge HCCs. Meanwhile,&#xD;
      microwave ablation (MWA) now has been shown to be safe and effective for local tumor control&#xD;
      in HCC patients. However, neither MWA nor TACE alone can achieve complete control of large&#xD;
      HCCs . Therefore, the combination of TACE and MWA (TACE+MWA) is an appealing approach to&#xD;
      treat HCCs. TACE+MWA now has been shown to improve overall survival rates compared with TACE&#xD;
      alone in patients with small to large HCCs. But little data is available on TACE+MWA in&#xD;
      patients with huge unresectable HCCs. Thus, the study was designed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2019</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Microwave Ablation Combined With TACE in the Treatment of Non-resectable Huge Hepatocellular Carcinoma</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per mRECIST) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event rate</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Adverse event rate will be defined as the rate of patients who developed adverse event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis-free survival</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented distant metastasis (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment .</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hepatocellular Carcinoma Non-resectable</condition>
  <condition>Transarterial Chemoembolization</condition>
  <condition>Microwave Ablation</condition>
  <arm_group>
    <arm_group_label>TACE+MWA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TACE</intervention_name>
    <description>TACE: With the patient under local anesthesia, a 5F French catheter was introduced into the abdominal aorta via the femoral artery using the Seldinger technique. Hepatic arterial angiography was performed using fluoroscopy to guide the catheter into the celiac and superior mesenteric arteries. Then, the feeding arteries, tumor, and vascular anatomy surrounding the tumor were identified. Subsequently, a microcatheter was super-selectively inserted into the feeding arteries. Then, a mixture solution containing chemotherapeutic agents and embolic agents were infused into the artery according to the size and blood supply of the tumors.</description>
    <arm_group_label>TACE+MWA</arm_group_label>
    <other_name>Transcatheter arterial chemoembolization procedure</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MWA</intervention_name>
    <description>MWA: All patients were instructed to fast from all foods for 12 hours preoperatively. During the procedure, a CT scan was used to locate the liver tumors, and to design the optimal puncture needle route. Routine disinfection and local anesthesia was applied around the puncture point, and a 16-gauge microwave antenna was gradually inserted into the tumor along the pre-determined angle. Settings of the MWA parameters depended on the manufacturer's recommendation and our experience.</description>
    <arm_group_label>TACE+MWA</arm_group_label>
    <other_name>Microwave ablation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MWA system</intervention_name>
    <description>MWA system is a kind of medical treatment instrument to restrain and kill tumor based on microwave heating technique and biology heating effect theory.</description>
    <arm_group_label>TACE+MWA</arm_group_label>
    <other_name>Microwave ablation system</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemoembolization</intervention_name>
    <description>Chemotherapeutic drugs: adriamycin，epirubicin and pirarubicin. Embolic agent: lipiodol and embolic microspherea The mixture solution containing chemotherapeutic drugs and embolic agent were infused into the artery according to by the number and size of the lesions, liver and kidney function of the patient, and blood supply of the tumors.</description>
    <arm_group_label>TACE+MWA</arm_group_label>
    <other_name>Chemotherapeutic drugs and Embolic agent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The performance status of Eastern Cooperative Oncology Group (ECOG) must be 0-1&#xD;
&#xD;
          2. The diagnosis of primary hepatocellular carcinoma must be in line with the American&#xD;
             Society for the study of liver diseases (AASLD) diagnostic criteria for hepatocellular&#xD;
             carcinoma (HCC)&#xD;
&#xD;
          3. Child-Pugh score A or B;&#xD;
&#xD;
          4. Aged from 18 to 75 years;&#xD;
&#xD;
          5. Subjects voluntarily join the study, and signe informed consent;&#xD;
&#xD;
          6. No anti-tumor therapy was received；&#xD;
&#xD;
          7. Meet the following 4 characteristics: A. primary tumor diameter more than or equal to&#xD;
             10cm; B. no more than 3 HCC foci, and the maximum diameter is less than or equal to&#xD;
             5cm; C. with IIa, I or no portal vein tumor thrombus (Cheng's Classification)；D. the&#xD;
             tumor could not be surgically removed&#xD;
&#xD;
          8. No extrahepatic metastases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Abnormal coagulation function: PLT &lt; 40×109/L, PTA &lt; 40%;&#xD;
&#xD;
          2. Patients have the past history of liver cancer treatment, such as transplantation,&#xD;
             resection, radiotherapy, chemotherapy and so on;&#xD;
&#xD;
          3. Patients participated in clinical trials of equipment or drugs (signed informed&#xD;
             consent) within 4 weeks;&#xD;
&#xD;
          4. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric&#xD;
             varices bleeding;&#xD;
&#xD;
          5. Any serious accompanying disease, which is expected to have an unknown, impact on the&#xD;
             prognosis, include heart disease, inadequately controlled diabetes and psychiatric&#xD;
             disorders;&#xD;
&#xD;
          6. Patients accompanied with other tumors or past medical history of malignancy;&#xD;
&#xD;
          7. Pregnant or lactating patients, all patients participating in this trial must adopt&#xD;
             appropriate birth control measures during treatment;&#xD;
&#xD;
          8. Allergic to adriamycin chemotherapy drugs，contrast agent and lipiodol;&#xD;
&#xD;
          9. Patients have poor compliance.&#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>Weijun Fan, M.D</last_name>
    <role>Study Chair</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Weijun Fan, M.D.</last_name>
    <phone>+86-020-87343272</phone>
    <email>fanweijun1964@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Han Qi, M.D.</last_name>
    <phone>+86-020-87343272</phone>
    <email>qihan@sysucc.org.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cancer Institute &amp;Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xiao Li, M.D</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Fujian Medical University</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350005</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhenyu Lin, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The tumor hospital of Fujian Province</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hailan Lin, M.D</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>the First Affiliated Hospital of SunYat-senUniversity</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jiaping Li, M.D</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shenzhen People's Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yanfang Zhang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University Hospital of Shenzhen</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518036</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Junhui Chen, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuliang Li, M.D</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shandong Province Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xin Ye, M.D</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>the Affiliated Hospital of Medical College Qingdao University</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>26555</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zixiang Li, M.D</last_name>
    </contact>
  </location>
  <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>Not yet recruiting</status>
    <contact>
      <last_name>Junhui Sun, M.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Maida M, Orlando E, Camma C, Cabibbo G. Staging systems of hepatocellular carcinoma: a review of literature. World J Gastroenterol. 2014 Apr 21;20(15):4141-50. doi: 10.3748/wjg.v20.i15.4141.</citation>
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    <citation>Yamashita Y, Taketomi A, Shirabe K, Aishima S, Tsuijita E, Morita K, Kayashima H, Maehara Y. Outcomes of hepatic resection for huge hepatocellular carcinoma (&gt;/= 10 cm in diameter). J Surg Oncol. 2011 Sep 1;104(3):292-8. doi: 10.1002/jso.21931. Epub 2011 Apr 4.</citation>
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    <citation>Brunocilla PR, Brunello F, Carucci P, Gaia S, Rolle E, Cantamessa A, Castiglione A, Ciccone G, Rizzetto M. Sorafenib in hepatocellular carcinoma: prospective study on adverse events, quality of life, and related feasibility under daily conditions. Med Oncol. 2013 Mar;30(1):345. doi: 10.1007/s12032-012-0345-2. Epub 2012 Dec 22.</citation>
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    <citation>Abdelaziz AO, Nabeel MM, Elbaz TM, Shousha HI, Hassan EM, Mahmoud SH, Rashed NA, Ibrahim MM, Abdelmaksoud AH. Microwave ablation versus transarterial chemoembolization in large hepatocellular carcinoma: prospective analysis. Scand J Gastroenterol. 2015 Apr;50(4):479-84. doi: 10.3109/00365521.2014.1003397. Epub 2015 Jan 16.</citation>
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    <citation>Xue T, Le F, Chen R, Xie X, Zhang L, Ge N, Chen Y, Wang Y, Zhang B, Ye S, Ren Z. Transarterial chemoembolization for huge hepatocellular carcinoma with diameter over ten centimeters: a large cohort study. Med Oncol. 2015 Mar;32(3):64. doi: 10.1007/s12032-015-0504-3. Epub 2015 Feb 15.</citation>
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    <citation>Min YW, Lee JH, Gwak GY, Paik YH, Lee JH, Rhee PL, Koh KC, Paik SW, Yoo BC, Choi MS. Long-term survival after surgical resection for huge hepatocellular carcinoma: comparison with transarterial chemoembolization after propensity score matching. J Gastroenterol Hepatol. 2014 May;29(5):1043-8. doi: 10.1111/jgh.12504.</citation>
    <PMID>24863186</PMID>
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  <reference>
    <citation>Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.</citation>
    <PMID>16495695</PMID>
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    <citation>Feng K, Yan J, Li X, Xia F, Ma K, Wang S, Bie P, Dong J. A randomized controlled trial of radiofrequency ablation and surgical resection in the treatment of small hepatocellular carcinoma. J Hepatol. 2012 Oct;57(4):794-802. doi: 10.1016/j.jhep.2012.05.007. Epub 2012 May 23.</citation>
    <PMID>22634125</PMID>
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    <citation>Lu MD, Kuang M, Liang LJ, Xie XY, Peng BG, Liu GJ, Li DM, Lai JM, Li SQ. [Surgical resection versus percutaneous thermal ablation for early-stage hepatocellular carcinoma: a randomized clinical trial]. Zhonghua Yi Xue Za Zhi. 2006 Mar 28;86(12):801-5. Chinese.</citation>
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    <citation>Huang YH, Wu JC, Chen SC, Chen CH, Chiang JH, Huo TI, Lee PC, Chang FY, Lee SD. Survival benefit of transcatheter arterial chemoembolization in patients with hepatocellular carcinoma larger than 10 cm in diameter. Aliment Pharmacol Ther. 2006 Jan 1;23(1):129-35. doi: 10.1111/j.1365-2036.2006.02704.x.</citation>
    <PMID>16393290</PMID>
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    <citation>Kim JH, Won HJ, Shin YM, Kim SH, Yoon HK, Sung KB, Kim PN. Medium-sized (3.1-5.0 cm) hepatocellular carcinoma: transarterial chemoembolization plus radiofrequency ablation versus radiofrequency ablation alone. Ann Surg Oncol. 2011 Jun;18(6):1624-9. doi: 10.1245/s10434-011-1673-8. Epub 2011 Mar 29.</citation>
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    <citation>Mizukoshi E, Yamashita T, Arai K, Sunagozaka H, Ueda T, Arihara F, Kagaya T, Yamashita T, Fushimi K, Kaneko S. Enhancement of tumor-associated antigen-specific T cell responses by radiofrequency ablation of hepatocellular carcinoma. Hepatology. 2013 Apr;57(4):1448-57. doi: 10.1002/hep.26153.</citation>
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    <citation>Zerbini A, Pilli M, Penna A, Pelosi G, Schianchi C, Molinari A, Schivazappa S, Zibera C, Fagnoni FF, Ferrari C, Missale G. Radiofrequency thermal ablation of hepatocellular carcinoma liver nodules can activate and enhance tumor-specific T-cell responses. Cancer Res. 2006 Jan 15;66(2):1139-46. doi: 10.1158/0008-5472.CAN-05-2244.</citation>
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    <citation>Kim YS, Lim HK, Rhim H, Lee MW, Choi D, Lee WJ, Paik SW, Koh KC, Lee JH, Choi MS, Gwak GY, Yoo BC. Ten-year outcomes of percutaneous radiofrequency ablation as first-line therapy of early hepatocellular carcinoma: analysis of prognostic factors. J Hepatol. 2013 Jan;58(1):89-97. doi: 10.1016/j.jhep.2012.09.020. Epub 2012 Sep 27.</citation>
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    <citation>Shiina S, Tateishi R, Arano T, Uchino K, Enooku K, Nakagawa H, Asaoka Y, Sato T, Masuzaki R, Kondo Y, Goto T, Yoshida H, Omata M, Koike K. Radiofrequency ablation for hepatocellular carcinoma: 10-year outcome and prognostic factors. Am J Gastroenterol. 2012 Apr;107(4):569-77; quiz 578. doi: 10.1038/ajg.2011.425. Epub 2011 Dec 13.</citation>
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    <citation>Peng ZW, Zhang YJ, Chen MS, Xu L, Liang HH, Lin XJ, Guo RP, Zhang YQ, Lau WY. Radiofrequency ablation with or without transcatheter arterial chemoembolization in the treatment of hepatocellular carcinoma: a prospective randomized trial. J Clin Oncol. 2013 Feb 1;31(4):426-32. doi: 10.1200/JCO.2012.42.9936. Epub 2012 Dec 26.</citation>
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    <citation>Kim JW, Shin SS, Kim JK, Choi SK, Heo SH, Lim HS, Hur YH, Cho CK, Jeong YY, Kang HK. Radiofrequency ablation combined with transcatheter arterial chemoembolization for the treatment of single hepatocellular carcinoma of 2 to 5 cm in diameter: comparison with surgical resection. Korean J Radiol. 2013 Jul-Aug;14(4):626-35. doi: 10.3348/kjr.2013.14.4.626. Epub 2013 Jul 17.</citation>
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  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>May 6, 2019</last_update_submitted>
  <last_update_submitted_qc>May 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Fan Weijun</investigator_full_name>
    <investigator_title>the professor of Sun Yat-sen University</investigator_title>
  </responsible_party>
  <keyword>Huge hepatocellular carcinoma</keyword>
  <keyword>Microwave ablation</keyword>
  <keyword>TACE</keyword>
  <keyword>Safety</keyword>
  <keyword>Non-resectable</keyword>
  <keyword>Treatment</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03277716
org study id: sysucc01
nct id: NCT03277716
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to prospectively evaluate the efficacy and safety of TACE
      combined with MWA in patients with huge unresectable hepatocellular carcinoma.
Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide. Despite the
      widespread application of surveillance programs in high-risk populations, patients continue
      to present with huge (≥ 10 cm) HCCs.And it's still a challenge to treat huge HCC
      nowadays.Surgical resection is currently the only curative treatment for huge HCCs ; however,
      only a minority of patients are candidates for curative resection. Sorafenib is recommended
      for the treatment of advanced HCCs, including huge HCCs, but the usage is severely limited by
      high adverse event rates and low efficiency. Thus, transarterial chemoembolization (TACE) is
      considered the first choice for huge unresectable HCCs. Several studies have concluded that
      TACE effectively improves the overall survival of patients with huge HCCs. Meanwhile,
      microwave ablation (MWA) now has been shown to be safe and effective for local tumor control
      in HCC patients. However, neither MWA nor TACE alone can achieve complete control of large
      HCCs . Therefore, the combination of TACE and MWA (TACE+MWA) is an appealing approach to
      treat HCCs. TACE+MWA now has been shown to improve overall survival rates compared with TACE
      alone in patients with small to large HCCs. But little data is available on TACE+MWA in
      patients with huge unresectable HCCs. Thus, the study was designed.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Microwave Ablation Combined With TACE in the Treatment of Non-resectable Huge Hepatocellular Carcinoma
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival (OS)
time frame: up to 3 years
description: Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.
measure: Progression-free survival (PFS)
time frame: up to 3 years
description: Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per mRECIST) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.
measure: Adverse event rate
time frame: up to 3 years
description: Adverse event rate will be defined as the rate of patients who developed adverse event.
measure: Distant metastasis-free survival
time frame: up to 3 years
description: Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented distant metastasis (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment .
arm group label: TACE+MWA
arm group type: Experimental
description: Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.
intervention type: Procedure
intervention name: TACE
description: TACE: With the patient under local anesthesia, a 5F French catheter was introduced into the abdominal aorta via the femoral artery using the Seldinger technique. Hepatic arterial angiography was performed using fluoroscopy to guide the catheter into the celiac and superior mesenteric arteries. Then, the feeding arteries, tumor, and vascular anatomy surrounding the tumor were identified. Subsequently, a microcatheter was super-selectively inserted into the feeding arteries. Then, a mixture solution containing chemotherapeutic agents and embolic agents were infused into the artery according to the size and blood supply of the tumors.
arm group label: TACE+MWA
other name: Transcatheter arterial chemoembolization procedure
intervention type: Procedure
intervention name: MWA
description: MWA: All patients were instructed to fast from all foods for 12 hours preoperatively. During the procedure, a CT scan was used to locate the liver tumors, and to design the optimal puncture needle route. Routine disinfection and local anesthesia was applied around the puncture point, and a 16-gauge microwave antenna was gradually inserted into the tumor along the pre-determined angle. Settings of the MWA parameters depended on the manufacturer's recommendation and our experience.
arm group label: TACE+MWA
other name: Microwave ablation
intervention type: Device
intervention name: MWA system
description: MWA system is a kind of medical treatment instrument to restrain and kill tumor based on microwave heating technique and biology heating effect theory.
arm group label: TACE+MWA
other name: Microwave ablation system
intervention type: Drug
intervention name: Chemoembolization
description: Chemotherapeutic drugs: adriamycin，epirubicin and pirarubicin. Embolic agent: lipiodol and embolic microspherea The mixture solution containing chemotherapeutic drugs and embolic agent were infused into the artery according to by the number and size of the lesions, liver and kidney function of the patient, and blood supply of the tumors.
arm group label: TACE+MWA
other name: Chemotherapeutic drugs and Embolic agent
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Weijun Fan, M.D
role: Study Chair
affiliation: Sun Yat-sen University
last name: Weijun Fan, M.D.
phone: +86-020-87343272
email: fanweijun1964@126.com
last name: Han Qi, M.D.
phone: +86-020-87343272
email: qihan@sysucc.org.cn
facility: 
status: Not yet recruiting
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status: Not yet recruiting
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country: China
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responsible party type: Sponsor-Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Fan Weijun
investigator title: the professor of Sun Yat-sen University
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: No