Clinical trial NCT02133079: Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96
Official title: Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Cancer
Pancreatic Adenocarcinoma
Lead sponsor: Cure&Sure Biotech Co., LTD
Sponsor class: INDUSTRY
Collaborators: name: Chinese Academy of Medical Sciences
First posted: 2014-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: blood count
timeFrame: baseline
measure: blood count
timeFrame: within 3 days after the second injection
measure: blood count
timeFrame: within 3 days after the 6th injection
measure: blood chemistries
timeFrame: baseline
measure: blood chemistries
timeFrame: within 3 days after the second injection
measure: blood chemistries
timeFrame: within 3 days after the 6th injection
measure: electrocardiogram
timeFrame: baseline
measure: electrocardiogram
timeFrame: within 3 days after the second injection
measure: electrocardiogram
timeFrame: within 3 days after the 6th injection
Secondary outcomes:
measure: Disease-free survival
timeFrame: up to 3 years
measure: overall survive
timeFrame: up to 3 years
measure: changes in antigen specific T cells
timeFrame: baseline and within 3 days before the 6th injection
Other outcomes:
measure: Change from baseline in subpopulation of CD8+ T cells at the end of vaccination
timeFrame: within 3 days before the first vaccination, within 3 days after the 6th vaccination
Locations:
city: Beijing
country: China
facility: Cancer Insititute and Hospital,Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Insititute and Hospital,Chinese Academy of Medical Sciences
name: Jianqiang Cai, meidical
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Insititute and Hospital,Chinese Academy of Medical Sciences
name: Lei Yu, medical
role: PRINCIPAL_INVESTIGATOR
References: