Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96

Phase 1

• Conditions: Liver Cancer; Pancreatic Adenocarcinoma

• Registration Number: NCT02133079
• Lead Sponsor: Cure&Sure Biotech Co., LTD

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2014-05-03
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-11
• Primary Completion: 2016-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
blood count	within 3 days after the 6th injection	blood count within 3 days after the 6th injection
blood chemistries	within 3 days after the 6th injection	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	within 3 days after the 6th injection	electrocardiogram test within 3 days after the 6th injection

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	up to 3 years
overall survive	up to 3 years
changes in antigen specific T cells	baseline and within 3 days before the 6th injection	tumor antigen specific T cells was determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.

Trial Locations

Locations (1)

Cancer Insititute and Hospital,Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China