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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) in combination with chemotherapy as Adjuvant Therapy in pancreatic cancer patients following surgical resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XH001 (dose 1) | Experimental | Biological: XH001
|
|
| XH001 (dose 2) | Experimental | Biological: XH001
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XH001 | Biological | mRNA neoantigen cancer vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| DFS | Disease Free Survival | From operation up to 36 months |
| DFS Rate | Disease-free survival rate | 12,24 and 36 months |
| MFS | metastasis-free survival | up to 36 months |
| OS | Overall survival | up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Specific immune response | Antigen-specific T-cell responses | up to 36 months |
| Adverse Event | Incidence and severity of adverse events (AEs), clinically significant abnormal changes in laboratory tests and 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 | |
|---|---|---|---|---|
| Wen Ming WU, Prof. | Contact | 86-10-69156874 | caodingyan@pumch.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37165196 | Background | Rojas LA, Sethna Z, Soares KC, Olcese C, Pang N, Patterson E, Lihm J, Ceglia N, Guasp P, Chu A, Yu R, Chandra AK, Waters T, Ruan J, Amisaki M, Zebboudj A, Odgerel Z, Payne G, Derhovanessian E, Muller F, Rhee I, Yadav M, Dobrin A, Sadelain M, Luksza M, Cohen N, Tang L, Basturk O, Gonen M, Katz S, Do RK, Epstein AS, Momtaz P, Park W, Sugarman R, Varghese AM, Won E, Desai A, Wei AC, D'Angelica MI, Kingham TP, Mellman I, Merghoub T, Wolchok JD, Sahin U, Tureci O, Greenbaum BD, Jarnagin WR, Drebin J, O'Reilly EM, Balachandran VP. Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer. Nature. 2023 Jun;618(7963):144-150. doi: 10.1038/s41586-023-06063-y. Epub 2023 May 10. |
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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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| Chemotherapy |
| Drug |
Gemcitabine+Capecitabine or Oxaliplatin+lrinotecan+Calcium folinate+5-FU |
|
| up to 36 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |