Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96

Cure&Sure Biotech

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Pancreatic Adenocarcinoma; Liver Cancer

Treatments: Biological: autologous gp96 vaccination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02133079

CS-CIH-Li-01

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

gp96 group

Experimental group

Description:

autologous gp96 vaccination + basal treatment

Treatment:

Biological: autologous gp96 vaccination