XH001 Combination With Immunocheckpoint Inhibitor And Chemotherapy For Patients With Resected Pancreatic Cancer

Study Overview

XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy 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.

N/A

Pancreatic Cancer

BIOLOGICAL: XH001
DRUG: Ipilimumab Injection
DRUG: Sintilimab injection
DRUG: Chemotherapy

XKY-C-004

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-03-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-01
First Submitted that Met QC Criteria 2024-04-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-04
First Posted (ACTUAL) 2024-04-09	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm A XH001;Ipilimumab Injection;Chemotherapy	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) DRUG: Chemotherapy gemcitabine + capecitabine
EXPERIMENTAL: Arm B XH001;Sintilimab Injection;Chemotherapy	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) DRUG: Chemotherapy gemcitabine + capecitabine

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm A

XH001;Ipilimumab Injection;Chemotherapy

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)

DRUG: Chemotherapy

gemcitabine + capecitabine

EXPERIMENTAL: Arm B

XH001;Sintilimab Injection;Chemotherapy

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)

DRUG: Chemotherapy

gemcitabine + capecitabine

Primary Outcome Measures	Measure Description	Time Frame
DFS	disease-free survival (DFS)	up to 36 months
DFS rate	disease-free survival rate	up to 36 months
MFS	metastasis-free survival (MFS)	up to 36 months
OS	overall survival (OS)	From date of recruitment until the date of first documented date of death from any cause, assessed up to 36 months

Secondary Outcome Measures	Measure Description	Time Frame
Elispot	Antigen-specific T-cell responses in peripheral blood	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
ctDNA	Changes of ctDNA compared to baseline	up to 36 months
CA19-9	Changes of CA19-9 compared to baseline	up to 36 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Wenming WU, Prof.

Phone Number: 86-10-69156874

Email: caodingyan@pumch.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

NeoCura

Investigators

PRINCIPAL_INVESTIGATOR: Wenming WU, Prof., Peking Union Medical College Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record