XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer
Recruiting now · Not applicable
Conditions studied: Pancreatic Cancer
In brief
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.
Key facts
- Study ID
- NCT06353646
- Run by
- Wu Wenming
- People needed
- 28
- Starts
- 2024-03-12
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-02-13
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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