solid tumor
Conditions
Interventions
Treatment group:Heat shock protein GP96 therapy
Sponsors
Yantai affiliated Hospital of Binzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old; and 2. Solid malignant tumor confirmed by pathohistology; 3. ECOG PS: 0-2; 4. Expected survival >= 6 months; 5. Laboratory test values meet the following conditions before the first dose of study drug: (1) Blood test (no blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days before screening): white blood cell (WBC) >=3.0 × 10^9/L; absolute neutrophil count (ANC) >=1.5 × 10^9/L; platelet (PLT) >=1.5 × 10^9/L; and blood pressure >=3.0 × 10^9/L. platelet (PLT) >=100 × 10^9/L; hemoglobin (HGB) >=9.0 g/dL; (2) Liver function: aspartate transferase (AST) =50 mL/minute (using the Cockcroft/Gault formula); (4) Coagulation: international normalized ratio (INR) 1.5 x ULN without clinical or imaging evidence of pancreatitis can be enrolled); amylase 1.5 x ULN without clinical or imaging evidence of pancreatitis can be enrolled); alkaline phosphatase (ALP) <=2.5 x ULN. ULN. 6. No active infection within two weeks; 7. Treatment with gp96-antigen peptide complex is planned by the treating physician; 8. Patients voluntarily participated in the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with severe heart disease, liver function impairment, kidney function impairment and other serious organ pathologies; 2. Patients with autoimmune diseases that require systemic treatment with immunosuppressants or hormones; 3. Patients undergoing other clinical trials or interventions; 4. Patients with intolerable side effects, or serious adverse events; 5. Contamination (including bacteria, viruses, fungi, etc.) during the preparation of the gp96 antigen-peptide complex; 6. Failure to store and transport the gp96 antigen-peptide complex in accordance with the experimental requirements; 7. Voluntary withdrawal of patients from this experiment; 8. Pregnant or lactating women; 9. Other patients deemed unsuitable for inclusion by the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in tumor size;survival;Safety evaluation index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematological indicators;Immunological index; | — |
Countries
China
Contacts
Public ContactYandong Miao
Yantai affiliated Hospital of Binzhou Medical University
Outcome results
None listed