A Phase 2/3 interventional study of gp96 in Liver Cancer, sponsored by Cure&Sure Biotech Co., LTD. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-20.
Sponsored by Cure&Sure Biotech Co., LTD · Phase 2/3, Interventional, and Treatment
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.
1,406 studies on the registry are indexed under Liver Neoplasms; 347 are open to participants now.
This study's planned enrollment of 80 is above the median of 47 across 975 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Cure&Sure Biotech Co., LTD is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Biological: gp96
Patients do not accept any anti-tumor treatmentsafter surgery
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.
2-year recurrence-free survival rate
Time frame: 2 year
Disease free survival
Time frame: 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
Time frame: 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.
Time frame: up to 3 months after vaccine completion
Overall survival
Time frame: 5 year
No study locations are listed for this record.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GP96
Cure&Sure Biotech Co., LTD