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Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma Stage III

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transhepatic Arterial Chemotherapy And Embolization (TACE)
Surgery
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma Stage III

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-80 years old, both gender
  • Confirmed diagnosis of stage III hepatocellular carcinoma(HCC)
  • Fulfill the criteria of surgery
  • No other severe comorbidity
  • Eastern Cooperative Oncology Group score(ECOG) 0-2
  • Expected survival > 3months
  • Informed consent obtained.

Exclusion Criteria:

  • Received chemoradiotherapy or other antineoplastic drugs
  • Severe cirrhosis with Child-Pugh score >10
  • Total bilirubin > 1.5 times upper limit, AST or ALT > 2times upper limit, indocyanine green retention rate after 15 min(ICG15) >=40%;
  • Not fulfill the surgery criteria
  • Received major surgery within 1month
  • History of other tumor
  • Participate other clinical trial within 1month
  • Drug or alcohol abuse, AIDS
  • Uncontrollable epileptic seizure or cognitive disorder
  • Severe allergy
  • Other unsuitable conditions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Neoadjuvant group

    Surgery group

    Arm Description

    Outcomes

    Primary Outcome Measures

    1-year disease free survival

    Secondary Outcome Measures

    1-year overall survival
    Rate of R0 resection
    objective response rate

    Full Information

    First Posted
    October 16, 2019
    Last Updated
    July 12, 2021
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04961138
    Brief Title
    Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular Carcinoma
    Official Title
    Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular Carcinoma: an Open, Random, Multicenter, Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2021 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of present study is to evaluate whether per-operative neoadjuvant therapy combined with surgery could improve the 1-year disease-free survival of stage III hepatocellular carcinoma patients.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    164 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Neoadjuvant group
    Arm Type
    Experimental
    Arm Title
    Surgery group
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Transhepatic Arterial Chemotherapy And Embolization (TACE)
    Other Intervention Name(s)
    lenvatinib
    Intervention Description
    Receiving TACE and lenvatinib before surgery.
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgery
    Intervention Description
    Removing tumor by surgery.
    Primary Outcome Measure Information:
    Title
    1-year disease free survival
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    1-year overall survival
    Time Frame
    1 year
    Title
    Rate of R0 resection
    Time Frame
    1 week
    Title
    objective response rate
    Time Frame
    up to 2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-80 years old, both gender Confirmed diagnosis of stage III hepatocellular carcinoma(HCC) Fulfill the criteria of surgery No other severe comorbidity Eastern Cooperative Oncology Group score(ECOG) 0-2 Expected survival > 3months Informed consent obtained. Exclusion Criteria: Received chemoradiotherapy or other antineoplastic drugs Severe cirrhosis with Child-Pugh score >10 Total bilirubin > 1.5 times upper limit, AST or ALT > 2times upper limit, indocyanine green retention rate after 15 min(ICG15) >=40%; Not fulfill the surgery criteria Received major surgery within 1month History of other tumor Participate other clinical trial within 1month Drug or alcohol abuse, AIDS Uncontrollable epileptic seizure or cognitive disorder Severe allergy Other unsuitable conditions.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuan Ding, MD
    Phone
    +8618858101960
    Email
    dingyuandy@126.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular Carcinoma

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