Back to resultsImmunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96
Primary Purpose
Liver Cancer, Pancreatic Adenocarcinoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
autologous gp96 vaccination
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer
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;
- Pancreatic cancer or primary liver cancer,must have undergone radical resection;
- Availability of at least 0.5 g tumor sample;
- Receiving the first gp96 autologous immunotherapy within 8 weeks of postoperation;
- Patients could not have received previous chemotherapy, radiation, or immunotherapy before 4 weeks of gp96 treatment；
- ECOG ≤1；life expectancy of at least 12 weeks
- 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:
- Unable to get the informed consent ;
- Patient not suitable for radical resection;
- Patients with active liver disease；
- Did not get enough tumor tissue ;
- Progression prior to vaccination as determined by the Principal Investigator;
- Rreceiving other anti-cancer therapy at the same time;
- Patient with allergic constitution;
- 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;
- Any other cilical trials within 30 days pre-vaccination;
- Female patients who are pregnant or breastfeeding.
Sites / Locations
- Cancer Insititute and Hospital,Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gp96 group
Arm Description
autologous gp96 vaccination + basal treatment
Outcomes
Primary Outcome Measures
blood count
blood count within 3 days before first vaccination
blood count
blood count within 3 days after the second injection
blood count
blood count within 3 days after the 6th injection
blood chemistries
blood 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 vaccination
blood chemistries
blood 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 injection
blood chemistries
blood 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 injection
electrocardiogram
electrocardiogram test within 3 days before first vaccination
electrocardiogram
electrocardiogram test within 3 days after the second injection
electrocardiogram
electrocardiogram test within 3 days after the 6th injection
Secondary Outcome Measures
Disease-free survival
overall survive
changes in antigen specific T cells
tumor antigen specific T cells was determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.
Full Information
NCT ID
NCT02133079
First Posted
May 3, 2014
Last Updated
December 10, 2015
Sponsor
Cure&Sure Biotech Co., LTD
Collaborators
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02133079
Brief Title
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
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cure&Sure Biotech Co., LTD
Collaborators
Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and Pancreatic Adenocarcinoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Pancreatic Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gp96 group
Arm Type
Experimental
Arm Description
autologous gp96 vaccination + basal treatment
Intervention Type
Biological
Intervention Name(s)
autologous gp96 vaccination
Intervention Description
vaccination of autologous gp96 derived from tumor tissue + basal treatment
Primary Outcome Measure Information:
Title
blood count
Description
blood count within 3 days before first vaccination
Time Frame
baseline
Title
blood count
Description
blood count within 3 days after the second injection
Time Frame
within 3 days after the second injection
Title
blood count
Description
blood count within 3 days after the 6th injection
Time Frame
within 3 days after the 6th injection
Title
blood chemistries
Description
blood 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 vaccination
Time Frame
baseline
Title
blood chemistries
Description
blood 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 injection
Time Frame
within 3 days after the second injection
Title
blood chemistries
Description
blood 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 injection
Time Frame
within 3 days after the 6th injection
Title
electrocardiogram
Description
electrocardiogram test within 3 days before first vaccination
Time Frame
baseline
Title
electrocardiogram
Description
electrocardiogram test within 3 days after the second injection
Time Frame
within 3 days after the second injection
Title
electrocardiogram
Description
electrocardiogram test within 3 days after the 6th injection
Time Frame
within 3 days after the 6th injection
Secondary Outcome Measure Information:
Title
Disease-free survival
Time Frame
up to 3 years
Title
overall survive
Time Frame
up to 3 years
Title
changes in antigen specific T cells
Description
tumor antigen specific T cells was determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.
Time Frame
baseline and within 3 days before the 6th injection
Other Pre-specified Outcome Measures:
Title
Change from baseline in subpopulation of CD8+ T cells at the end of vaccination
Description
analysis of the expression of CCR7 & CD45RA of CD8+ T cells by FCM within 3 days before first vaccination and within 3 days after the 6th vaccination.
Time Frame
within 3 days before the first vaccination, within 3 days after the 6th vaccination
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;
Pancreatic cancer or primary liver cancer,must have undergone radical resection;
Availability of at least 0.5 g tumor sample;
Receiving the first gp96 autologous immunotherapy within 8 weeks of postoperation;
Patients could not have received previous chemotherapy, radiation, or immunotherapy before 4 weeks of gp96 treatment；
ECOG ≤1；life expectancy of at least 12 weeks
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:
Unable to get the informed consent ;
Patient not suitable for radical resection;
Patients with active liver disease；
Did not get enough tumor tissue ;
Progression prior to vaccination as determined by the Principal Investigator;
Rreceiving other anti-cancer therapy at the same time;
Patient with allergic constitution;
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;
Any other cilical trials within 30 days pre-vaccination;
Female patients who are pregnant or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianqiang Cai, meidical
Organizational Affiliation
Cancer Insititute and Hospital,Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lei Yu, medical
Organizational Affiliation
Cancer Insititute and Hospital,Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Insititute and Hospital,Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
12. IPD Sharing Statement
Learn more about this trial
Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96
We'll reach out to this number within 24 hrs