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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06353646
Other study ID # XKY-C-004
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date December 2026

Study information

Verified date April 2024
Source Peking Union Medical College Hospital
Contact Wenming WU, Prof.
Phone 86-10-69156874
Email caodingyan@pumch.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 ipilimumab and chemotherapy in pancreatic cancer patients following surgical resection.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date December 2026
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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-a; - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
XH001
mRNA neoantigen cancer vaccine
Drug:
Ipilimumab Injection
a type of immunotherapy that targets CTLA-4 protein on T cells
Chemotherapy
gemcitabine + capecitabine

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Wu Wenming NeoCura

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary DFS disease-free survival (DFS) up to 36 months
Primary 1-year DFS rate disease-free survival rate of 1 year 1 year
Primary MFS metastasis-free survival (MFS) up to 36 months
Primary OS overall survival (OS) From date of recruitment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Secondary Elispot Antigen-specific T-cell responses in peripheral blood up to 36 months
Secondary Adverse Event Incidence and severity of adverse events (AEs), clinically significant abnormal changes in laboratory tests and other investigations (based on the Criteria for the Evaluation of Adverse Events [CTCAE] v5.0). up to 36 months
Secondary ctDNA Changes of ctDNA compared to baseline up to 36 months
Secondary CA19-9 Changes of CA19-9 compared to baseline up to 36 months
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