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Adjuvant Transcatheter Arterial Chemoembolization Versus Adjuvant Systemic Chemotherapy for Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
systemic chemotherapy
Transcatheter Arterial Chemoembolization
Sponsored by
Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. a preoperative diagnosis of HCC with no previous treatment;
  2. compensated cirrhosis with Child-Pugh class A, B or no cirrhosis;
  3. multiple tumors more than 5 cm or tumor involving a major branch (the Wrstor second branch) of the portal or hepatic vein(s) on preoperative investigations, and on intraoperative ultrasonography and gross examination of the liver during operation;
  4. on exploration and intraoperative ultrasonography, the tumor with multiple lesions localized in right or left hemiliver,or the main tumor localized in one lobe only with a small solitary lesion in contralateral lobe, or tumor involving a major branch (the Wrst or second branch) of the portal or hepatic vein(s), which could be safely resected without grossly remaining tumors, and the patient was judged to have well preserved liver function to survive the operation.
  5. Adequate organ and marrow function, with neutrophil count≥1.5X10e9/L, platelet count≥75×10e9/L, AST or ALT﹤2.5×upper limit of normal (ULN), total bilirubin<1.5×ULN, international normalized ratio <1.5;normal baseline left ventricular ejection fraction_lower limit of normal for the institution. Patients with AST and ALT<5 ×ULN could be recruited if total bilirubin was in the normal range.

Exclusion Criteria:

  1. documented allergy to study drugs; any previous TACE or systemic chemotherapy treatment before random assignment;
  2. concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion);
  3. CNS metastasis;
  4. Other serious illness or medical condition.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    systemic chemotherapy

    Transcatheter Arterial Chemoembolization

    Arm Description

    Pirarubicin(Brand Name:Pirarubicin - Main Luck Pharmaceutical, China) 30mg/m2 intravenously on Day 1 and Oxaliplatin(Brand Name: Eloxatin) 100 mg/m2 intravenously on Day 2 every 3 weeks within 4-6 weeks after hepatic resection(a total of 4 cycles).

    Transcatheter Arterial Chemoembolization (Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using gelatin sponge particles(Gelfoam; Guangzhou)) within 4-6 weeks after hepatic resection(a total of 1 cycle).

    Outcomes

    Primary Outcome Measures

    recurrence free survival

    Secondary Outcome Measures

    Overall survival
    Time to Recurrence
    Time to Recurrence within liver
    Time of tumor distant metastasis

    Full Information

    First Posted
    October 20, 2015
    Last Updated
    June 1, 2019
    Sponsor
    Guangxi Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02584556
    Brief Title
    Adjuvant Transcatheter Arterial Chemoembolization Versus Adjuvant Systemic Chemotherapy for Hepatocellular Carcinoma
    Official Title
    A Randomized Controlled Trial of Radical Hepatectomy With Adjuvant Transcatheter Arterial Chemoembolization Versus Adjuvant Systemic Chemotherapy for Hepatocellular Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    October 2015 (Anticipated)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    October 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guangxi Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine that adjuvant systemic chemotherapy is superior to adjuvant transcatheter arterial chemoembolization(TACE) in prolonging recurrence free survival(RFS) in patients after radical resection of hepatocellular carcinoma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    systemic chemotherapy
    Arm Type
    Experimental
    Arm Description
    Pirarubicin(Brand Name:Pirarubicin - Main Luck Pharmaceutical, China) 30mg/m2 intravenously on Day 1 and Oxaliplatin(Brand Name: Eloxatin) 100 mg/m2 intravenously on Day 2 every 3 weeks within 4-6 weeks after hepatic resection(a total of 4 cycles).
    Arm Title
    Transcatheter Arterial Chemoembolization
    Arm Type
    Active Comparator
    Arm Description
    Transcatheter Arterial Chemoembolization (Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using gelatin sponge particles(Gelfoam; Guangzhou)) within 4-6 weeks after hepatic resection(a total of 1 cycle).
    Intervention Type
    Drug
    Intervention Name(s)
    systemic chemotherapy
    Intervention Description
    Pirarubicin(Brand Name:Pirarubicin - Main Luck Pharmaceutical, China) 30mg/m2 intravenously on Day 1 and Oxaliplatin(Brand Name: Eloxatin) 100 mg/m2 intravenously on Day 2 every 3 weeks starting 4-6 weeks after hepatic resection.
    Intervention Type
    Drug
    Intervention Name(s)
    Transcatheter Arterial Chemoembolization
    Intervention Description
    Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using gelatin sponge particles(Gelfoam; Guangzhou) starting 4-6 weeks after hepatic resection.
    Primary Outcome Measure Information:
    Title
    recurrence free survival
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Overall survival
    Time Frame
    3 months and 24 months
    Title
    Time to Recurrence
    Time Frame
    6 months and 12 months
    Title
    Time to Recurrence within liver
    Time Frame
    3 months and 12 months
    Title
    Time of tumor distant metastasis
    Time Frame
    3 months and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: a preoperative diagnosis of HCC with no previous treatment; compensated cirrhosis with Child-Pugh class A, B or no cirrhosis; multiple tumors more than 5 cm or tumor involving a major branch (the Wrstor second branch) of the portal or hepatic vein(s) on preoperative investigations, and on intraoperative ultrasonography and gross examination of the liver during operation; on exploration and intraoperative ultrasonography, the tumor with multiple lesions localized in right or left hemiliver,or the main tumor localized in one lobe only with a small solitary lesion in contralateral lobe, or tumor involving a major branch (the Wrst or second branch) of the portal or hepatic vein(s), which could be safely resected without grossly remaining tumors, and the patient was judged to have well preserved liver function to survive the operation. Adequate organ and marrow function, with neutrophil count≥1.5X10e9/L, platelet count≥75×10e9/L, AST or ALT﹤2.5×upper limit of normal (ULN), total bilirubin<1.5×ULN, international normalized ratio <1.5;normal baseline left ventricular ejection fraction_lower limit of normal for the institution. Patients with AST and ALT<5 ×ULN could be recruited if total bilirubin was in the normal range. Exclusion Criteria: documented allergy to study drugs; any previous TACE or systemic chemotherapy treatment before random assignment; concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion); CNS metastasis; Other serious illness or medical condition.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lequn Li, PhD
    Organizational Affiliation
    Affiliated Tumor Hospital, Guangxi Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19408012
    Citation
    Zhong C, Guo RP, Li JQ, Shi M, Wei W, Chen MS, Zhang YQ. A randomized controlled trial of hepatectomy with adjuvant transcatheter arterial chemoembolization versus hepatectomy alone for Stage III A hepatocellular carcinoma. J Cancer Res Clin Oncol. 2009 Oct;135(10):1437-45. doi: 10.1007/s00432-009-0588-2. Epub 2009 May 1.
    Results Reference
    background
    PubMed Identifier
    19285298
    Citation
    Peng BG, He Q, Li JP, Zhou F. Adjuvant transcatheter arterial chemoembolization improves efficacy of hepatectomy for patients with hepatocellular carcinoma and portal vein tumor thrombus. Am J Surg. 2009 Sep;198(3):313-8. doi: 10.1016/j.amjsurg.2008.09.026. Epub 2009 Mar 12.
    Results Reference
    background
    PubMed Identifier
    23980077
    Citation
    Qin S, Bai Y, Lim HY, Thongprasert S, Chao Y, Fan J, Yang TS, Bhudhisawasdi V, Kang WK, Zhou Y, Lee JH, Sun Y. Randomized, multicenter, open-label study of oxaliplatin plus fluorouracil/leucovorin versus doxorubicin as palliative chemotherapy in patients with advanced hepatocellular carcinoma from Asia. J Clin Oncol. 2013 Oct 1;31(28):3501-8. doi: 10.1200/JCO.2012.44.5643. Epub 2013 Aug 26.
    Results Reference
    background

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    Adjuvant Transcatheter Arterial Chemoembolization Versus Adjuvant Systemic Chemotherapy for Hepatocellular Carcinoma

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