Pancreatic Cancer
Conditions
Keywords
cancer vaccine, mRNA, neoantigen, Pancreatic Cancer, adjuvant therapy
Brief summary
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.
Interventions
BIOLOGICALXH001
XH001 will be administered 12 weeks post-tumor resection (+/- 2 weeks)
Ipilimumab will be administered 12 weeks post-tumor resection (+/- 2 weeks)
Sintilimab will be administered 12 weeks post-tumor resection (+/- 2 weeks)
DRUGChemotherapy
gemcitabine + capecitabine
Sponsors
Wu Wenming
NeoCura
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form; * Aged 18 to 75 years old; * Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma; * Completed an R0 or R1 surgical resection as determined by pathology； * Have not received any prior neoadjuvant therapy; * ECOG score is 0 or 1; * Life expectancy of greater than 12 months; * CA19-9 \<100U/mL before initial chemotherapy; * Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug. * Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.
Exclusion criteria
* Borderline resectable pancreatic cancer; * Evidence of disease recurrence or metastasis following surgical resection at any time; * Evidence of malignant ascites; * Pre-existing inflammatory bowel disease or the presence of complete or partial bowel obstruction, or persistent severe diarrhea after surgery; * Needs to receive long-term systemic anti-allergic drug or known hypersensitivity to any component of the study treatment; * History of autoimmune disease; * New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke, and transient ischemic attack) within 6 months before screening; * Acute myocardial infarction within 6 months before screening, or uncontrolled angina, uncontrolled arrhythmia, severe heart failure (see Appendix 3, New York Heart Association Heart Failure Classification Criteria NYHA Class ≥ III) and other cardiovascular diseases; * Received immunomodulatory medications within 4 weeks prior to the date of the first dose (D1) of XH001, including but not limited to: IL-2, CTLA-4 inhibitors, CD40 agonists, CD137 agonists, IFN-α; * Received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 7 days prior to the first dose of XH001; * Received therapeutic tumor vaccines; * With congenital or acquired immunodeficiency; * Participating in other clinical trials and had not withdrawn during screening period; * Unable or unwilling to comply with the study protocol due to potential health, mental or social conditions in the opinion of the investigator; * Other conditions that, in the opinion of the investigator, would make participation in this study inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS | From date of operation until the date of first documented date of death from any cause, assessed up to 36 months | overall survival (OS) |
| DFS | From operation up to 36 months | disease-free survival (DFS) |
| DFS rate | DFS rate at 12,24, and 36 months after operation | disease-free survival rate |
| MFS | From operation up to 36 months | metastasis-free survival (MFS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Elispot | up to 36 months | Antigen-specific T-cell responses in peripheral blood |
| Adverse Event | up to 36 months | 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). |
| ctDNA | up to 36 months | Changes of ctDNA compared to baseline |
| CA19-9 | up to 36 months | Changes of CA19-9 compared to baseline |
Countries
China
Contacts
CONTACTWenming WU, Prof.
PRINCIPAL_INVESTIGATORWenming WU, Prof.
Peking Union Medical College Hospital
Outcome results
None listed