Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96

Liver Cancer Clinical Trial

Official title:

Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02133079
• Other study ID #: CS-CIH-Li-01
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: May 3, 2014
• Last updated: December 10, 2015
• Start date: March 2012
• Est. completion date: November 2019

Study information

• Verified date: December 2015
• Source: Cure&Sure Biotech Co., LTD
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 2019
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Liver Cancer
• Pancreatic Adenocarcinoma

Intervention

Biological:
• autologous gp96 vaccination
vaccination of autologous gp96 derived from tumor tissue + basal treatment

Locations

Country	Name	City	State
China	Cancer Insititute and Hospital,Chinese Academy of Medical Sciences	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Cure&Sure Biotech Co., LTD	Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	blood count	blood count within 3 days before first vaccination	baseline	Yes
Primary	blood count	blood count within 3 days after the second injection	within 3 days after the second injection	Yes
Primary	blood count	blood count within 3 days after the 6th injection	within 3 days after the 6th injection	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	electrocardiogram	electrocardiogram test within 3 days before first vaccination	baseline	Yes
Primary	electrocardiogram	electrocardiogram test within 3 days after the second injection	within 3 days after the second injection	Yes
Primary	electrocardiogram	electrocardiogram test within 3 days after the 6th injection	within 3 days after the 6th injection	Yes
Secondary	Disease-free survival		up to 3 years	No
Secondary	overall survive		up to 3 years	No
Secondary	changes in antigen specific T cells	tumor antigen specific T cells was determined by IFN-? Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.	baseline and within 3 days before the 6th injection	No