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| Name | Class |
|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
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This trial is to further study the safety and effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work
RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.
Overall Goals:
- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.
Primary Aim:
- to further evaluate effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work.
Secondary Aims:
to study the immune response to vaccination, to monitor clinical responses , to further the safety of vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gp96 group | Experimental | 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. |
|
| Control group | No Intervention | Patients do not accept any anti-tumor treatmentsafter surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gp96 | Biological | heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year recurrence-free survival rate | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | 5 year | |
| changes in antigen specific T cells | tumor antigen specific T cells are determined by IFN-γ Enzyme-linked Tumor antigen specific T cells will be determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C018551 | glucose-regulated proteins |
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| within 3 days before the first vaccination and within 10 days after the last vaccination |
| Number of participants with adverse events related to gp96 immunotherapy | A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason.And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 5.0 criteria. | up to 3 months after vaccine completion |
| Overall survival | 5 year |
| D008107 |
| Liver Diseases |