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| Name | Class |
|---|---|
| Hangzhou Neoantigen Therapeutics Co., Ltd. | INDUSTRY |
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This research study is evaluating a new type of pancreatic cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of resectable pancreatic cancer, so as to provide a new personalized therapeutic strategy.
It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized neoantigen vaccines | Experimental | iNeo-Vac-P01 (peptides): 4 x 300 mcg per peptide given on days 1, 4, 8, 15, 22, 52, and 82 for a total of 7 doses; GM-CSF: 4 x 40 mcg (total dose 160 mcg) given on days 1, 4, 8, 15, 22, 52, and 82 for a total of 7 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iNeo-Vac-P01 | Biological | iNeo-Vac-P01 (peptides): 300 mcg per peptide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing clinical and laboratory adverse events (AEs) | Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 | 1 years |
| Relapse Free Survival(RFS) | Time from surgery to any recurrence | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | Time from surgery to death or last follow-up | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of CD4/CD8 T lymphocyte subsets | 2 years | |
| The polypeptide antigen - induced IFN-γ T cells responses | 2 years | |
| Peripheral blood T cell receptor sequencing analysis |
Inclusion Criteria:
Must freely sign informed consent;
Aged 18 to 70 years old;
Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma;
Must provide all exons of tumor tissue sequencing data, transcriptome sequencing data and the peripheral blood of all exons sequencing data;
ECOG score is 0 or 1;
Completed an R0 or R1 surgical resection as determined by pathologyï¼›
Completion of at least 4 months of adjuvant chemotherapy with ticgio monotherapy or mFOLFIRINOX;
Completion of imaging records 1 week before personalized immunotherapy, including but not limited to full-body PET-CT and brain MRI,
The end of chemotherapy is followed by a one-week natural washout periodï¼›
Haematological index:
Pregnant, lactating women and women of child-bearing age must have a negative pregnancy test within 7 days before entering the group, and short-term have no fertility plan, and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial;
Good compliance, able to follow research protocols and follow-up procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Liu, M.D. | Contact | 13666601475 | yangliuqq2003@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yang Liu, Liu | Zhejiang Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D000276 | Adjuvants, Immunologic |
| D003115 | Colony-Stimulating Factors |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
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| GM-CSF | Other | GM-CSF: 40 mcg |
|
|
| 2 years |
| D016207 |
| Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |