Pancreatic Cancer
Conditions
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) in combination with chemotherapy as Adjuvant Therapy in pancreatic cancer patients following surgical resection.
Interventions
BIOLOGICALXH001
mRNA neoantigen cancer vaccine
DRUGChemotherapy
Gemcitabine+Capecitabine or Oxaliplatin+lrinotecan+Calcium folinate+5-FU
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
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 pancreatic ductal adenocarcinoma; * R0 or R1 surgical resection as determined by pathology； * Have not received any prior neoadjuvant therapy; * ECOG score is 0 or 1; * 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 metastasis or disease recurrence 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; * 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 not enrolled at the 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 |
|---|---|---|
| DFS | From operation up to 36 months | Disease Free Survival |
| DFS Rate | 12,24 and 36 months | Disease-free survival rate |
| MFS | up to 36 months | metastasis-free survival |
| OS | up to 48 months | Overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specific immune response | up to 36 months | Antigen-specific T-cell responses |
| Adverse Event | up to 36 months | 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). |
Countries
China
Contacts
Primary ContactWen Ming WU, Prof.
Outcome results
None listed