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

Study Overview

• Status: Unknown
• Conditions: Pancreatic Adenocarcinoma; Liver Cancer
• Intervention / Treatment: Biological: autologous gp96 vaccination

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100021
    • Cancer Insititute and Hospital,Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gp96 group; autologous gp96 vaccination + basal treatment	Biological: autologous gp96 vaccination; vaccination of autologous gp96 derived from tumor tissue + basal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood count	blood count within 3 days before first vaccination	baseline
blood count	blood count within 3 days after the second injection	within 3 days after the second injection
blood count	blood count within 3 days after the 6th injection	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	baseline
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	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	within 3 days after the 6th injection
electrocardiogram	electrocardiogram test within 3 days before first vaccination	baseline
electrocardiogram	electrocardiogram test within 3 days after the second injection	within 3 days after the second injection
electrocardiogram	electrocardiogram test within 3 days after the 6th injection	within 3 days after the 6th injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival		up to 3 years
overall survive		up to 3 years
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.	baseline and within 3 days before the 6th injection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in subpopulation of CD8+ T cells at the end of vaccination	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.	within 3 days before the first vaccination, within 3 days after the 6th vaccination

Collaborators and Investigators

• Sponsor: Cure&Sure Biotech Co., LTD
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Jianqiang Cai, meidical, Cancer Insititute and Hospital,Chinese Academy of Medical Sciences; Principal Investigator: Lei Yu, medical, Cancer Insititute and Hospital,Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: May 3, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimate): May 7, 2014

Study Record Updates

• Last Update Posted (Estimate): December 11, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Adenocarcinoma; Liver Neoplasms
• Other Study ID Numbers: CS-CIH-Li-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No