Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96
NCT ID: NCT02133079
Last Updated: 2015-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2012-03-31
2019-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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gp96 group
autologous gp96 vaccination + basal treatment
autologous gp96 vaccination
vaccination of autologous gp96 derived from tumor tissue + basal treatment
Interventions
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autologous gp96 vaccination
vaccination of autologous gp96 derived from tumor tissue + basal treatment
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Cure&Sure Biotech Co., LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Jianqiang Cai, meidical
Role: PRINCIPAL_INVESTIGATOR
Cancer Insititute and Hospital,Chinese Academy of Medical Sciences
Lei Yu, medical
Role: PRINCIPAL_INVESTIGATOR
Cancer Insititute and Hospital,Chinese Academy of Medical Sciences
Locations
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Cancer Insititute and Hospital,Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Other Identifiers
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CS-CIH-Li-01
Identifier Type: -
Identifier Source: org_study_id