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Pancreatic CancerNCT07114666

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

A study testing XH001 and Chemotherapy in people with Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
XH001 and Chemotherapy
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
18 Aug 2025to Aug 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wen Ming WU, Prof. contact

86-10-69156874

caodingyan@pumch.cn

China1 site

  • Peking Union Medical College Hospital

    Beijing, 100730

Other trials in China

About this study

Official title: Efficacy and Safety of XH001 (New Antigen Tumor Vaccine) Combined With Chemotherapy as Adjuvant Therapy in Pancreatic Cancer Patients

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.

Being tested
XH001, Chemotherapy
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XH001Biological

    mRNA neoantigen cancer vaccine

  • ChemotherapyDrug

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

Study groups in NCT07114666
Study groupRoleWhat they receive
XH001 (dose 1)ExperimentalBiological: XH001 * mRNA neoantigen cancer vaccine（Dose 1） Drug: Chemotherapy * gemcitabine+capecitabine * oxaliplatin+lrinotecan+calcium folinate+5-FU
Receives: Biological: XH001; Drug: Chemotherapy
XH001 (dose 2)ExperimentalBiological: XH001 * mRNA neoantigen cancer vaccine(Dose 2) Drug: Chemotherapy * gemcitabine+capecitabine * oxaliplatin+lrinotecan+calcium folinate+5-FU
Receives: Biological: XH001; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DFS

    Disease Free Survival

    Measured: From operation up to 36 months

  2. DFS Rate

    Disease-free survival rate

    Measured: 12,24 and 36 months

  3. MFS

    metastasis-free survival

    Measured: up to 36 months

  4. OS

    Overall survival

    Measured: up to 48 months

Secondary outcomes (2)

  1. Specific immune response

    Antigen-specific T-cell responses

    Measured: up to 36 months

  2. Adverse Event

    Incidence and severity of adverse events (AEs), clinically significant abnormal changes in laboratory tests and other examinations (based on the Criteria for the Evaluation of Adverse Events [CTCAE] v5.0).

    Measured: up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2025
  2. Study start18 Aug 2025 (estimated)
  3. Primary completionAug 2029 (estimated)
  4. Study completionAug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07114666
Sponsor's protocol ID
I-25PJ0773
Status last verified
Aug 2025
First submitted
3 Aug 2025
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37165196

Questions about this trial

What is this clinical trial studying?

A study testing XH001 and Chemotherapy in people with Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wen Ming WU, Prof. (86-10-69156874, caodingyan@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DFS (time frame: From operation up to 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07114666, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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