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Clinical Trials in China / NCT07114666
Starting soon Not applicable

XH001 (New Antigen Tumor Vaccine) Combined With Chemotherapy as Adjuvant Therapy in Pancreatic Cancer

NCT07114666 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Not applicable
Started
2025-08-18
Last updated
2025-08-11

Condition(s) studied

Pancreatic Cancer

Investigational drug(s) / intervention(s)

XH001 →Chemotherapy

XH001: mRNA neoantigen cancer vaccine

Chemotherapy: Gemcitabine+Capecitabine or Oxaliplatin+lrinotecan+Calcium folinate+5-FU

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing China

More Peking Union Medical College Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07114666 on ClinicalTrials.gov ↗ ← All trials in China