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Systemic Chemotherapy Versus Transcatheter Arterial Chemoembolization(TACE) for Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pirarubicin
Oxaliplatin
Lipiodol
Gelfoam
Sponsored by
Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Eligible patients were age 18 to 75 years;
  • The patients had histologically, cytologically,or clinically diagnosed unresectable HCC;and were ineligible for local invasive treatment. Clinically diagnosed patients had to have: (1) evidence of HBV or HCV with hepatic cirrhosis; (2) a-fetoprotein levels 400g/L; and (3) morphologic evidence of hypervascular liver tumor. Patients had to have at least one measurable lesion according to RECIST (version 1.0; ≥2 cm on computed tomography [CT]; 1 cm on spiral CT or magnetic resonance imaging). Lesions that had undergone previous interventional or local therapy were not considered measurable lesions.
  • ECOG score≤2;
  • life expectancy 3 months;
  • Barcelona Clinic liver cancer (BCLC) stage B or C disease;
  • Child-Pugh stage A or B disease;
  • 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.
  • Patients had to provide signed informed consent to participate.

Exclusion Criteria:

  • documented allergy to lipoidal or other study drugs; any previous treatment before random assignment;
  • Previous liver transplantation;
  • 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.

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 30mg/m2 intravenously on Day 1 and Oxaliplatin 100 mg/m2 intravenously on Day 2 every 3 weeks until disease progression or limiting toxicity.

    Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using Gelfoam every 4 weeks until disease progression or limiting toxicity.

    Outcomes

    Primary Outcome Measures

    Progression-Free-Survival

    Secondary Outcome Measures

    Objective response rate
    Overall survival
    Time-to-Progression
    Time-to-Progression within liver
    Time-to-Progression outside the liver

    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
    NCT02585479
    Brief Title
    Systemic Chemotherapy Versus Transcatheter Arterial Chemoembolization(TACE) for Hepatocellular Carcinoma
    Official Title
    Systemic Chemotherapy VersusTranscatheter Arterial Chemoembolization As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma(HCC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    It doesn't meet the requirements of randomized trials
    Study Start Date
    October 2015 (Actual)
    Primary Completion Date
    October 2017 (Actual)
    Study Completion Date
    October 2017 (Actual)

    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 systemic chemotherapy is superior to transcatheter arterial chemoembolization in prolonging progression-free survival(PFS) in patients with Advanced 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
    Treatment
    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 30mg/m2 intravenously on Day 1 and Oxaliplatin 100 mg/m2 intravenously on Day 2 every 3 weeks until disease progression or limiting toxicity.
    Arm Title
    Transcatheter Arterial Chemoembolization
    Arm Type
    Active Comparator
    Arm Description
    Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using Gelfoam every 4 weeks until disease progression or limiting toxicity.
    Intervention Type
    Drug
    Intervention Name(s)
    Pirarubicin
    Intervention Description
    Pirarubicin 30mg/m2 intravenously Pirarubicin17mg/m2 are infused through the right and left hepatic arteries
    Intervention Type
    Drug
    Intervention Name(s)
    Oxaliplatin
    Other Intervention Name(s)
    Eloxatin
    Intervention Description
    Oxaliplatin 100 mg/m2 intravenously Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries
    Intervention Type
    Drug
    Intervention Name(s)
    Lipiodol
    Intervention Description
    Lipiodol 5-10ml infused through the right and left hepatic arteries
    Intervention Type
    Device
    Intervention Name(s)
    Gelfoam
    Intervention Description
    Hepatic artery embolization with Gelfoam.
    Primary Outcome Measure Information:
    Title
    Progression-Free-Survival
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Objective response rate
    Time Frame
    3 months
    Title
    Overall survival
    Time Frame
    6 months and 12 months
    Title
    Time-to-Progression
    Time Frame
    3 months
    Title
    Time-to-Progression within liver
    Time Frame
    3 months
    Title
    Time-to-Progression outside the liver
    Time Frame
    3 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: Eligible patients were age 18 to 75 years; The patients had histologically, cytologically,or clinically diagnosed unresectable HCC;and were ineligible for local invasive treatment. Clinically diagnosed patients had to have: (1) evidence of HBV or HCV with hepatic cirrhosis; (2) a-fetoprotein levels 400g/L; and (3) morphologic evidence of hypervascular liver tumor. Patients had to have at least one measurable lesion according to RECIST (version 1.0; ≥2 cm on computed tomography [CT]; 1 cm on spiral CT or magnetic resonance imaging). Lesions that had undergone previous interventional or local therapy were not considered measurable lesions. ECOG score≤2; life expectancy 3 months; Barcelona Clinic liver cancer (BCLC) stage B or C disease; Child-Pugh stage A or B disease; 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. Patients had to provide signed informed consent to participate. Exclusion Criteria: documented allergy to lipoidal or other study drugs; any previous treatment before random assignment; Previous liver transplantation; 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
    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
    PubMed Identifier
    15555291
    Citation
    Li L, Sun F, Chen AJ, Li XY, Hu MD, Ran JH, Tang JH. [Capecitabine combined with TACE for advanced liver cancer]. Zhonghua Zhong Liu Za Zhi. 2004 Sep;26(9):565-6. Chinese.
    Results Reference
    background
    PubMed Identifier
    19453695
    Citation
    Mabed M, Esmaeel M, El-Khodary T, Awad M, Amer T. A randomized controlled trial of transcatheter arterial chemoembolization with lipiodol, doxorubicin and cisplatin versus intravenous doxorubicin for patients with unresectable hepatocellular carcinoma. Eur J Cancer Care (Engl). 2009 Sep;18(5):492-9. doi: 10.1111/j.1365-2354.2008.00984.x.
    Results Reference
    background

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    Systemic Chemotherapy Versus Transcatheter Arterial Chemoembolization(TACE) for Hepatocellular Carcinoma

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