Clinical trial · Interventional
Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96
NCT02133079CI-TRIAL-00020171unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and Pancreatic Adenocarcinoma
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous gp96 vaccination | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- gp96 group
- description
- autologous gp96 vaccination + basal treatment
- interventionNames
- Biological: autologous gp96 vaccination
Primary outcomes (9)
- measure
- blood count
- timeFrame
- baseline
- description
- blood count within 3 days before first vaccination
- measure
- blood count
- timeFrame
- within 3 days after the second injection
- description
- blood count within 3 days after the second injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.