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

NCT06353646 | Recruiting

• 1 other identifier: XKY-C-004
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Keywords

cancer vaccine, mRNA, neoantigen; Pancreatic Cancer; adjuvant therapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Elispot

  up to 36 months

• Adverse Event

  up to 36 months

• ctDNA

  up to 36 months

• CA19-9

  up to 36 months

Study Arms (2)

Arm A

EXPERIMENTAL

XH001;Ipilimumab Injection;Chemotherapy

Biological: XH001; Drug: Ipilimumab Injection; Drug: Chemotherapy

Arm B

EXPERIMENTAL

XH001;Sintilimab Injection;Chemotherapy

Biological: XH001; Drug: Sintilimab injection; Drug: Chemotherapy

Interventions

XH001 BIOLOGICAL

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

Arm A; Arm B

Ipilimumab Injection DRUG

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

Arm A

Sintilimab injection DRUG

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

Arm B

Chemotherapy DRUG

gemcitabine + capecitabine

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wu Wenming: lead
• NeoCura: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Ipilimumab; sintilimab; Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Wenming WU, Prof.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenming WU, Prof.

CONTACT

86-10-69156874; caodingyan@pumch.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 9, 2024
• Study Start: March 12, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)