XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer

Efficacy and Safety Trial of XH001 (Neoantigen Cancer Vaccine) Sequential Combination With Immunocheckpoint Inhibitor and Chemotherapy in Adjuvant Therapy for Patients With Resected Pancreatic Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Chemotherapy; Biological: XH001; Drug: Ipilimumab Injection; Drug: Sintilimab injection

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenming WU, Prof.; Phone Number: 86-10-69156874; Email: caodingyan@pumch.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Dingyan Cao, Dr.; Email: caodingyan@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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-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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; XH001;Ipilimumab Injection;Chemotherapy	Drug: Chemotherapy; gemcitabine + capecitabine; Biological: XH001; XH001 will be administered 12 weeks post-tumor resection (+/- 2 weeks); Drug: Ipilimumab Injection; Ipilimumab will be administered 12 weeks post-tumor resection (+/- 2 weeks)
Experimental: Arm B; XH001;Sintilimab Injection;Chemotherapy	Drug: Chemotherapy; gemcitabine + capecitabine; Biological: XH001; XH001 will be administered 12 weeks post-tumor resection (+/- 2 weeks); Drug: Sintilimab injection; Sintilimab will be administered 12 weeks post-tumor resection (+/- 2 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS	disease-free survival (DFS)	From operation up to 36 months
DFS rate	disease-free survival rate	DFS rate at 12,24, and 36 months after operation
MFS	metastasis-free survival (MFS)	From operation up to 36 months
OS	overall survival (OS)	From date of operation until the date of first documented date of death from any cause, assessed up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elispot	Antigen-specific T-cell responses in peripheral blood	up to 36 months
ctDNA	Changes of ctDNA compared to baseline	up to 36 months
CA19-9	Changes of CA19-9 compared to baseline	up to 36 months
Adverse Event	Incidence and severity of adverse events (AEs), clinically significant abnormal changes in laboratory tests or other examinations (based on the Criteria for the Evaluation of Adverse Events [CTCAE] v5.0).	up to 36 months

Collaborators and Investigators

• Sponsor: Wu Wenming
• Collaborators: NeoCura
• Investigators: Principal Investigator: Wenming WU, Prof., Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 7, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: adjuvant therapy; Pancreatic Cancer; cancer vaccine, mRNA, neoantigen
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Ipilimumab; Drug Therapy; sintilimab
• Other Study ID Numbers: XKY-C-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No