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

NCT ID: NCT06353646

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-12
• Study Completion Date: 2026-12-31

Brief 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 immunocheckpoint inhibitor and chemotherapy in pancreatic cancer patients following surgical resection.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

XH001;Ipilimumab Injection;Chemotherapy

Group Type: EXPERIMENTAL

XH001

Intervention Type: BIOLOGICAL

XH001 will be administered 12 weeks post-tumor resection (+/- 2 weeks)

Ipilimumab Injection

Intervention Type: DRUG

Ipilimumab will be administered 12 weeks post-tumor resection (+/- 2 weeks)

Chemotherapy

Intervention Type: DRUG

gemcitabine + capecitabine

Arm B

XH001;Sintilimab Injection;Chemotherapy

Group Type: EXPERIMENTAL

XH001

Intervention Type: BIOLOGICAL

XH001 will be administered 12 weeks post-tumor resection (+/- 2 weeks)

Sintilimab injection

Intervention Type: DRUG

Sintilimab will be administered 12 weeks post-tumor resection (+/- 2 weeks)

Chemotherapy

Intervention Type: DRUG

gemcitabine + capecitabine

Interventions

XH001

XH001 will be administered 12 weeks post-tumor resection (+/- 2 weeks)

Intervention Type: BIOLOGICAL

Ipilimumab Injection

Ipilimumab will be administered 12 weeks post-tumor resection (+/- 2 weeks)

Intervention Type: DRUG

Sintilimab injection

Sintilimab will be administered 12 weeks post-tumor resection (+/- 2 weeks)

Intervention Type: DRUG

Chemotherapy

gemcitabine + capecitabine

Intervention Type: DRUG

Eligibility Criteria

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeoCura

INDUSTRY

Sponsor Role: collaborator

Wu Wenming

OTHER

Sponsor Role: lead

Responsible Party

Wu Wenming

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wenming WU, Prof.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenming WU, Prof.

Role: CONTACT

caodingyan@pumch.cn

86-10-69156874

Facility Contacts

Dingyan Cao, Dr.

Role: primary

caodingyan@pumch.cn

Other Identifiers

XKY-C-004

Identifier Type: -

Identifier Source: org_study_id