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Clinical Trial Record

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Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96

2012-03

2016-11

2019-11

20

Study Overview

Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96

To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and Pancreatic Adenocarcinoma

N/A

  • Liver Cancer
  • Pancreatic Adenocarcinoma
  • BIOLOGICAL: autologous gp96 vaccination
  • CS-CIH-Li-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2014-05-03  

N/A  

2015-12-10  

2014-05-06  

N/A  

2015-12-11  

2014-05-07  

N/A  

2015-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: gp96 group

autologous gp96 vaccination + basal treatment

BIOLOGICAL: autologous gp96 vaccination

  • vaccination of autologous gp96 derived from tumor tissue + basal treatment
Primary Outcome MeasuresMeasure DescriptionTime Frame
blood countblood count within 3 days before first vaccinationbaseline
blood countblood count within 3 days after the second injectionwithin 3 days after the second injection
blood countblood count within 3 days after the 6th injectionwithin 3 days after the 6th injection
blood chemistriesblood chemistries (including serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], serum alanine amino transferase [ALT], serum alkaline phosphatase, serum total bilirubin, serum blood urea nitrogen[BUN], serum creatinine, serum total protein and serum albumin) within 3 days before first vaccinationbaseline
blood chemistriesblood chemistries (including serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], serum alanine amino transferase [ALT], serum alkaline phosphatase, serum total bilirubin, serum blood urea nitrogen[BUN], serum creatinine, serum total protein and serum albumin) within 3 days after the second injectionwithin 3 days after the second injection
blood chemistriesblood chemistries (including serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], serum alanine amino transferase [ALT], serum alkaline phosphatase, serum total bilirubin, serum blood urea nitrogen[BUN], serum creatinine, serum total protein and serum albumin) within 3 days after the 6th injectionwithin 3 days after the 6th injection
electrocardiogramelectrocardiogram test within 3 days before first vaccinationbaseline
electrocardiogramelectrocardiogram test within 3 days after the second injectionwithin 3 days after the second injection
electrocardiogramelectrocardiogram test within 3 days after the 6th injectionwithin 3 days after the 6th injection
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Disease-free survivalup to 3 years
overall surviveup to 3 years
changes in antigen specific T cellstumor antigen specific T cells was determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.baseline and within 3 days before the 6th injection

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts 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. Pancreatic cancer or primary liver cancer,must have undergone radical resection; 4. Availability of at least 0.5 g tumor sample; 5. Receiving the first gp96 autologous immunotherapy within 8 weeks of postoperation; 6. Patients could not have received previous chemotherapy, radiation, or immunotherapy before 4 weeks of gp96 treatment； 7. ECOG ≤1；life expectancy of at least 12 weeks 8. 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 bilirubin (total) <1.5 times IULN), and adequate renal function (BUN and creatinine <1.5 times IULNs); 9. Agree to Surgical indications of Heart & lung and without the coagulation system disease;
    10.Negative pregnancy test for female patients of childbearing potential; 11.Agree to use contraception or abstain from sexual activity from the time of consent through 3 month after the end of study drug administration.
    Exclusion Criteria:
    1. Unable to get the informed consent ; 2. Patient not suitable for radical resection; 3. Patients with active liver disease； 4. Did not get enough tumor tissue ; 5. Progression prior to vaccination as determined by the Principal Investigator; 6. Rreceiving other anti-cancer therapy at the same time; 7. Patient with allergic constitution; 8. Unstable or severe intercurrent medical conditions; 9. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection; 10. Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids; 11. Any other cilical trials within 30 days pre-vaccination; 12. Female patients who are pregnant or breastfeeding.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Chinese Academy of Medical Sciences
  • PRINCIPAL_INVESTIGATOR: Jianqiang Cai, meidical, Cancer Insititute and Hospital,Chinese Academy of Medical Sciences

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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