Overview

This trial is active, not recruiting.

Conditions liver cancer, pancreatic adenocarcinoma
Treatment autologous gp96 vaccination
Phase phase 1/phase 2
Sponsor Cure&Sure Biotech Co., LTD
Collaborator Chinese Academy of Medical Sciences
Start date March 2012
End date November 2016
Trial size 20 participants
Trial identifier NCT02133079, CS-CIH-Li-01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
autologous gp96 vaccination + basal treatment
autologous gp96 vaccination
vaccination of autologous gp96 derived from tumor tissue + basal treatment

Primary Outcomes

Measure
blood count
time frame: baseline
blood count
time frame: within 3 days after the second injection
blood count
time frame: within 3 days after the 6th injection
blood chemistries
time frame: baseline
blood chemistries
time frame: within 3 days after the second injection
blood chemistries
time frame: within 3 days after the 6th injection
electrocardiogram
time frame: baseline
electrocardiogram
time frame: within 3 days after the second injection
electrocardiogram
time frame: within 3 days after the 6th injection

Secondary Outcomes

Measure
Disease-free survival
time frame: up to 3 years
overall survive
time frame: up to 3 years
changes in antigen specific T cells
time frame: baseline and within 3 days before the 6th injection

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96
Principal investigator Jianqiang Cai, meidical
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Cure&Sure Biotech Co., LTD.