Clinical trial · Interventional
Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96
NCT02317471CI-TRIAL-00022489unknownPhase 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)
The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Carcinoma | Gastric Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous gp96 vaccination | Biological | — | UNRESOLVED |
| Oxaliplatin+S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- gp96 group
- description
- autologous gp96 vaccination + basal treatment for gastric cancer
- interventionNames
- Biological: autologous gp96 vaccination
- Drug: Oxaliplatin+S-1
- type
- OTHER
- label
- control group
- description
- Oxaliplatin+S-1
- interventionNames
- Drug: Oxaliplatin+S-1
Primary outcomes (2)
- measure
- Disease free survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Disease characteristics: Histologically confirmed gastric carcinoma: clinical stage III (according to the Japanese gastric cancer classification), must have undergone radical resection 2. Able to read and understand the informed consent document, must sign the informed consent 3. Age: 18 to 75 years old 4. Availability of at least 0.5 g tumor sample 5. ECOG ≤1；life expectancy \>=12 weeks, able to comply with study-related procedures 6. 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) 7. Normal heart function 8. NOT participate in ANY other clinical trials within 4 weeks prior to vaccination. Exclusion Criteria: 1. Unable to get the informed consent 2. Female patients who are pregnant or breastfeeding 3. Progression prior to treatment as determined by the principal investigator 4. Transplant recipient 5. Patients currently diagnosed with Human Immunodeficiency Virus or other active uncontrolled infection 6. Unstable or severe intercurrent medical conditions 7. Patient with allergic constitution 8. Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.
References
Publications (0)
Data not yet available
No reference posted for this study.