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The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in postoperative adjuvant treatment of Pancreatic Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy | Experimental | (1)8 cycles of Gemcitabine +capecitabine (Gemcitabine d1,8 ,Capecitabine d1-14 q3w);(2) two 200 mg intravenous dose of tislelizumab (d1,q3w)(3)five intravenous doses of neoantigen vaccines given as priming doses(d1,8,22,36,50)and two booster dose(d80,d110) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy | Drug | Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines |
|
| Measure | Description | Time Frame |
|---|---|---|
| 18-month RFS | defined recurrence as new lesions on the basis of response evaluation criteria in solid tumours (v.1.1), and RFS from either the date of surgery (RFS) or from the date of the last neoantigen vaccine priming dose to the date of recurrence or death, whichever occurred first. | through study completion, an average of 2 year |
| Incidence of Treatment-Related Adverse Events [Safety and Tolerability] | Defined by treatment-related adverse events as assessed by CTCAE v4.0 | 3 months after the last administration of neoantigen vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| 18-month OS | defined OS from the date of surgery to the date of death. | through study completion, an average of 3 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhong Wu, MD | Contact | 028-85422851 | wuzhong5555@126.com |
| Name | Affiliation | Role |
|---|---|---|
| zhong Wu, MD | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610000 | 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 |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |