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GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver Cancer

Primary Purpose

Liver Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
gp96
Sponsored by
Cure&Sure Biotech Co., LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. Able to read and understand the informed consent document; must sign the informed consent;
  2. Aged 18 to 75 years old , sex is not limited;
  3. must have undergone radical resection;AJCC TNM II、III、IV.
  4. Availability of at least 1g tumor sample;
  5. Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3; Hemoglobin > 10g/dL ; platelet count >100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], alanine amino transferase [ALT] <2.5 times institutional upper limit of normals [IULNs] ), and adequate renal function (BUN and creatinine <1.5 times IULNs)
  6. Agree to Surgical indications of Heart & lung and without the coagulation system disease
  7. Patients could not have received previous anti-cancer treat before 4 weeks of gp96 treatment；

Exclusion Criteria:

  1. Inability to comply with study-related procedures
  2. Unavailability of at least 6 doses of vaccine
  3. Severe allergies
  4. Unstable or severe intercurrent medical conditions
  5. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection.
  6. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.
  7. Female patients who are pregnant or breastfeeding
  8. Steroidal drugs are currently being used systemically.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    gp96 group

    Control group

    Arm Description

    Patients only receive autologous gp96 vaccination after surgery (do not accept other anti-tumor treatments) 6 times of gp96 vaccination are administered via subcutaneous injection in 25μg doses within 8 weeks after surgery. gp96 is administered once a week.

    Patients do not accept any anti-tumor treatmentsafter surgery

    Outcomes

    Primary Outcome Measures

    2-year recurrence-free survival rate

    Secondary Outcome Measures

    Disease free survival
    changes in antigen specific T cells
    tumor antigen specific T cells are determined by IFN-γ Enzyme-linked Tumor antigen specific T cells will be determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen
    Number of participants with adverse events related to gp96 immunotherapy
    A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason.And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 5.0 criteria.
    Overall survival

    Full Information

    First Posted
    December 18, 2019
    Last Updated
    December 18, 2019
    Sponsor
    Cure&Sure Biotech Co., LTD
    Collaborators
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04206254
    Brief Title
    GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver Cancer
    Official Title
    GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 19, 2019 (Anticipated)
    Primary Completion Date
    August 5, 2022 (Anticipated)
    Study Completion Date
    August 5, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cure&Sure Biotech Co., LTD
    Collaborators
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    This trial is to further study the safety and effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work
    Detailed Description
    RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells. Overall Goals: - to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome. Primary Aim: - to further evaluate effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work. Secondary Aims: to study the immune response to vaccination, to monitor clinical responses , to further the safety of vaccine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    gp96 group
    Arm Type
    Experimental
    Arm Description
    Patients only receive autologous gp96 vaccination after surgery (do not accept other anti-tumor treatments) 6 times of gp96 vaccination are administered via subcutaneous injection in 25μg doses within 8 weeks after surgery. gp96 is administered once a week.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patients do not accept any anti-tumor treatmentsafter surgery
    Intervention Type
    Biological
    Intervention Name(s)
    gp96
    Intervention Description
    heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.
    Primary Outcome Measure Information:
    Title
    2-year recurrence-free survival rate
    Time Frame
    2 year
    Secondary Outcome Measure Information:
    Title
    Disease free survival
    Time Frame
    5 year
    Title
    changes in antigen specific T cells
    Description
    tumor antigen specific T cells are determined by IFN-γ Enzyme-linked Tumor antigen specific T cells will be determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen
    Time Frame
    within 3 days before the first vaccination and within 10 days after the last vaccination
    Title
    Number of participants with adverse events related to gp96 immunotherapy
    Description
    A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason.And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 5.0 criteria.
    Time Frame
    up to 3 months after vaccine completion
    Title
    Overall survival
    Time Frame
    5 year

    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: Able to read and understand the informed consent document; must sign the informed consent; Aged 18 to 75 years old , sex is not limited; must have undergone radical resection;AJCC TNM II、III、IV. Availability of at least 1g tumor sample; Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3; Hemoglobin > 10g/dL ; platelet count >100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], alanine amino transferase [ALT] <2.5 times institutional upper limit of normals [IULNs] ), and adequate renal function (BUN and creatinine <1.5 times IULNs) Agree to Surgical indications of Heart & lung and without the coagulation system disease Patients could not have received previous anti-cancer treat before 4 weeks of gp96 treatment； Exclusion Criteria: Inability to comply with study-related procedures Unavailability of at least 6 doses of vaccine Severe allergies Unstable or severe intercurrent medical conditions Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids. Female patients who are pregnant or breastfeeding Steroidal drugs are currently being used systemically.

    12. IPD Sharing Statement

    Learn more about this trial

    GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver Cancer

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