XH001 (New Antigen Tumor Vaccine) Combined With Chemotherapy as Adjuvant Therapy in Pancreatic Cancer

NCT07114666 | Not Yet Recruiting

• 1 other identifier: I-25PJ0773
• Study Type: interventional
• Target: 12
• 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) in combination with chemotherapy as Adjuvant Therapy in pancreatic cancer patients following surgical resection.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (4)

• DFS

  Disease Free Survival

  From operation up to 36 months

• DFS Rate

  Disease-free survival rate

  12,24 and 36 months

• MFS

  metastasis-free survival

  up to 36 months

• OS

  Overall survival

  up to 48 months

Secondary Outcomes (2)

• Specific immune response

  up to 36 months

• Adverse Event

  up to 36 months

Study Arms (2)

XH001 (dose 1)

EXPERIMENTAL

Biological: XH001 * mRNA neoantigen cancer vaccine（Dose 1） Drug: Chemotherapy * gemcitabine+capecitabine * oxaliplatin+lrinotecan+calcium folinate+5-FU

Biological: XH001; Drug: Chemotherapy

XH001 (dose 2)

EXPERIMENTAL

Biological: XH001 * mRNA neoantigen cancer vaccine(Dose 2) Drug: Chemotherapy * gemcitabine+capecitabine * oxaliplatin+lrinotecan+calcium folinate+5-FU

Biological: XH001; Drug: Chemotherapy

Interventions

XH001 BIOLOGICAL

mRNA neoantigen cancer vaccine

XH001 (dose 1); XH001 (dose 2)

Chemotherapy DRUG

Gemcitabine+Capecitabine or Oxaliplatin+lrinotecan+Calcium folinate+5-FU

XH001 (dose 1); XH001 (dose 2)

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 pancreatic ductal adenocarcinoma;
• R0 or R1 surgical resection as determined by pathology；
• Have not received any prior neoadjuvant therapy;
• ECOG score is 0 or 1;
• 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 metastasis or disease recurrence 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;
• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Related Publications (1)

• Rojas LA, Sethna Z, Soares KC, Olcese C, Pang N, Patterson E, Lihm J, Ceglia N, Guasp P, Chu A, Yu R, Chandra AK, Waters T, Ruan J, Amisaki M, Zebboudj A, Odgerel Z, Payne G, Derhovanessian E, Muller F, Rhee I, Yadav M, Dobrin A, Sadelain M, Luksza M, Cohen N, Tang L, Basturk O, Gonen M, Katz S, Do RK, Epstein AS, Momtaz P, Park W, Sugarman R, Varghese AM, Won E, Desai A, Wei AC, D'Angelica MI, Kingham TP, Mellman I, Merghoub T, Wolchok JD, Sahin U, Tureci O, Greenbaum BD, Jarnagin WR, Drebin J, O'Reilly EM, Balachandran VP. Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer. Nature. 2023 Jun;618(7963):144-150. doi: 10.1038/s41586-023-06063-y. Epub 2023 May 10.

  PMID: 37165196 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

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)

Therapeutics

Central Study Contacts

Wen Ming 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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)