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| Name | Class |
|---|---|
| NeoCura | INDUSTRY |
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This is a single-center, open label, single-arm, investigator-initiated study to evaluate the efficacy and safety of XH001 (neoantigen cancer vaccine) sequential combination with immunocheckpoint inhibitor and chemotherapy in pancreatic cancer patients following surgical resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | XH001;Ipilimumab Injection;Chemotherapy |
|
| Arm B | Experimental | XH001;Sintilimab Injection;Chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XH001 | Biological | XH001 will be administered 12 weeks post-tumor resection (+/- 2 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| DFS | disease-free survival (DFS) | From operation up to 36 months |
| DFS rate | disease-free survival rate | DFS rate at 12,24, and 36 months after operation |
| MFS | metastasis-free survival (MFS) | From operation up to 36 months |
| OS | overall survival (OS) | From date of operation until the date of first documented date of death from any cause, assessed up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Elispot | Antigen-specific T-cell responses in peripheral blood | up to 36 months |
| Adverse Event | Incidence and severity of adverse events (AEs), clinically significant abnormal changes in laboratory tests or other examinations (based on the Criteria for the Evaluation of Adverse Events [CTCAE] v5.0). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenming WU, Prof. | Contact | 86-10-69156874 | caodingyan@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wenming WU, Prof. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | 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 |
|---|---|
| D000074324 | Ipilimumab |
| C000632826 | sintilimab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Ipilimumab Injection | Drug | Ipilimumab will be administered 12 weeks post-tumor resection (+/- 2 weeks) |
|
| Sintilimab injection | Drug | Sintilimab will be administered 12 weeks post-tumor resection (+/- 2 weeks) |
|
| Chemotherapy | Drug | gemcitabine + capecitabine |
|
| up to 36 months |
| ctDNA | Changes of ctDNA compared to baseline | up to 36 months |
| CA19-9 | Changes of CA19-9 compared to baseline | up to 36 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |