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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences | OTHER |
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To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and Pancreatic Adenocarcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gp96 group | Experimental | autologous gp96 vaccination + basal treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous gp96 vaccination | Biological | vaccination of autologous gp96 derived from tumor tissue + basal treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| blood count | blood count within 3 days before first vaccination | baseline |
| blood count | blood count within 3 days after the second injection | within 3 days after the second injection |
| blood count | blood count within 3 days after the 6th injection | within 3 days after the 6th injection |
| blood chemistries | blood chemistries (including serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], serum alanine amino transferase [ALT], serum alkaline phosphatase, serum total bilirubin, serum blood urea nitrogen[BUN], serum creatinine, serum total protein and serum albumin) within 3 days before first vaccination | baseline |
| blood chemistries | blood chemistries (including serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], serum alanine amino transferase [ALT], serum alkaline phosphatase, serum total bilirubin, serum blood urea nitrogen[BUN], serum creatinine, serum total protein and serum albumin) within 3 days after the second injection | within 3 days after the second injection |
| blood chemistries | blood chemistries (including serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], serum alanine amino transferase [ALT], serum alkaline phosphatase, serum total bilirubin, serum blood urea nitrogen[BUN], serum creatinine, serum total protein and serum albumin) within 3 days after the 6th injection | within 3 days after the 6th injection |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | up to 3 years | |
| overall survive | up to 3 years | |
| changes in antigen specific T cells |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in subpopulation of CD8+ T cells at the end of vaccination | analysis of the expression of CCR7 & CD45RA of CD8+ T cells by FCM within 3 days before first vaccination and within 3 days after the 6th vaccination. | within 3 days before the first vaccination, within 3 days after the 6th vaccination |
Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jianqiang Cai, meidical | Cancer Insititute and Hospital,Chinese Academy of Medical Sciences | Principal Investigator |
| Lei Yu, medical | Cancer Insititute and Hospital,Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Insititute and Hospital,Chinese Academy of Medical Sciences | Beijing | 100021 | China |
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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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| electrocardiogram | electrocardiogram test within 3 days before first vaccination | baseline |
| electrocardiogram | electrocardiogram test within 3 days after the second injection | within 3 days after the second injection |
| electrocardiogram | electrocardiogram test within 3 days after the 6th injection | within 3 days after the 6th injection |
tumor antigen specific T cells was determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen. |
| baseline and within 3 days before the 6th injection |
| D008107 |
| Liver Diseases |