XH001 Combination With Ipilimumab and Chemotherapy for Patients With Resected Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Efficacy and Safety Trial of XH001 (Neoantigen Cancer Vaccine) Sequential Combination With Ipilimumab and Chemotherapy for Patients With Resected Pancreatic Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06353646
• Other study ID #: XKY-C-004
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

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