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Trial Title:
Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96
NCT ID:
NCT02133079
Condition:
Liver Cancer
Pancreatic Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Liver Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
autologous gp96 vaccination
Description:
vaccination of autologous gp96 derived from tumor tissue + basal treatment
Arm group label:
gp96 group
Summary:
To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and
Pancreatic Adenocarcinoma
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Insititute and Hospital,Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Start date:
March 2012
Completion date:
November 2019
Lead sponsor:
Agency:
Cure&Sure Biotech Co., LTD
Agency class:
Industry
Collaborator:
Agency:
Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cure&Sure Biotech Co., LTD
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02133079
