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| Name | Class |
|---|---|
| Jiangsu Synthgene Biotechnology Co.Ltd. | UNKNOWN |
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The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines.
The first purpose of this study is to evaluate the safety of treating pancreatic cancer with surgery to remove cancerour tissue.
Following with camrelizumab and a personalized Neoantigen mRNA Vaccines, and then with chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic Cancer | Experimental | Resectable primary pancreatic tumor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | Tumors of patients with pancreatic cancer must be radiographically resectable, and subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) | To observe and evaluate the safety of Neoantigen mRNA vaccine combined with Camrelizumab, for the number of participants with treatment-related adverse events as assessed by CTCAE v5.0. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | The efficacy of Neoantigen mRNA vaccine combined with Camrelizumab by tumor lesion recurrence cycle at different time. | 3,6,12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinbo Wang, MD | Contact | 13505172912 | wxinbo2008@163.com | |
| Sizhen Wang, MD | Contact | 15195900565 | wsizhen@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinbo Wang, MD | Jinling Hospital, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wang Sizhen | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| C000631724 | camrelizumab |
| D000082082 | Immune Checkpoint Inhibitors |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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|
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| Camrelizumab | Drug | Camrelizumab will be administered 6 weeks post-tumor resection. |
|
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| SJ-Neo006 | Biological | SJ-Neo006 will be prepared as personalized tumor Vaccines and administered 9 weeks post-tumor resection (+/- 2 weeks). |
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| Gemcitabine+Abraxane | Drug | Gemcitabine+Abraxane regimen will be administered 21 weeks post-tumor resection. |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D013812 | Therapeutics |