Clinical trial · Interventional
GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver Cancer
GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver
NCT04206254CI-TRIAL-00042440unknownPhase 2 / Phase 3ClinicalTrials.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)
This trial is to further study the safety and effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work
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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gp96 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- gp96 group
- description
- Patients only receive autologous gp96 vaccination after surgery (do not accept other anti-tumor treatments) 6 times of gp96 vaccination are administered via subcutaneous injection in 25μg doses within 8 weeks after surgery. gp96 is administered once a week.
- interventionNames
- Biological: gp96
- type
- NO_INTERVENTION
- label
- Control group
- description
- Patients do not accept any anti-tumor treatmentsafter surgery
Primary outcomes (1)
- measure
- 2-year recurrence-free survival rate
- timeFrame
- 2 year
Secondary outcomes (4)
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. must have undergone radical resection;AJCC TNM II、III、IV. 4. Availability of at least 1g tumor sample; 5. 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 adequate renal function (BUN and creatinine \<1.5 times IULNs) 6. Agree to Surgical indications of Heart \& lung and without the coagulation system disease 7. Patients could not have received previous anti-cancer treat before 4 weeks of gp96 treatment； Exclusion Criteria: 1. Inability to comply with study-related procedures 2. Unavailability of at least 6 doses of vaccine 3. Severe allergies 4. Unstable or severe intercurrent medical conditions 5. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection. 6. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids. 7. Female patients who are pregnant or breastfeeding 8. Steroidal drugs are currently being used systemically.
References
Publications (0)
Data not yet available
No reference posted for this study.