Pancreatic CancerNCT06353646
XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer
A study testing XH001, Ipilimumab Injection and Sintilimab injection in people with Pancreatic Cancer, run by Wu Wenming at 1 site in China.
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) sequential combination with immunocheckpoint inhibitor and chemotherapy 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, Ipilimumab Injection and Sintilimab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2024to Dec 2026
- 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 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Dingyan Cao, Dr., caodingyan@pumch.cn
About this study
Official title: Efficacy and Safety Trial of XH001 (Neoantigen Cancer Vaccine) Sequential Combination With Immunocheckpoint Inhibitor and Chemotherapy in Adjuvant Therapy 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.
- Conditions
- Pancreatic Cancer
- Being tested
- XH001, Ipilimumab Injection, Sintilimab injection, Chemotherapy
- Keywords
- cancer vaccine, mRNA, neoantigen, Pancreatic Cancer, adjuvant therapy
- 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
XH001 will be administered 12 weeks post-tumor resection (+/- 2 weeks)
Ipilimumab InjectionDrug
Ipilimumab will be administered 12 weeks post-tumor resection (+/- 2 weeks)
Sintilimab injectionDrug
Sintilimab will be administered 12 weeks post-tumor resection (+/- 2 weeks)
ChemotherapyDrug
gemcitabine + capecitabine
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | XH001;Ipilimumab Injection;Chemotherapy Receives: Biological: XH001; Drug: Ipilimumab Injection; Drug: Chemotherapy |
| Arm B | Experimental | XH001;Sintilimab Injection;Chemotherapy Receives: Biological: XH001; Drug: Sintilimab injection; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
disease-free survival (DFS)
Measured: From operation up to 36 months
DFS rate
disease-free survival rate
Measured: DFS rate at 12,24, and 36 months after operation
MFS
metastasis-free survival (MFS)
Measured: From operation up to 36 months
OS
overall survival (OS)
Measured: 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
Antigen-specific T-cell responses in peripheral blood
Measured: 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).
Measured: up to 36 months
ctDNA
Changes of ctDNA compared to baseline
Measured: up to 36 months
CA19-9
Changes of CA19-9 compared to baseline
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.
- First posted9 Apr 2024
- Study start12 Mar 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wu Wenming
- Sponsor type
- University, hospital or other
- Collaborators
- NeoCura
- Responsible party
- Sponsor-investigator, Wu Wenming, Peking Union Medical College Hospital
- Investigators
- Wenming WU, Prof., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353646
- Sponsor's protocol ID
- XKY-C-004
- Status last verified
- Feb 2026
- First submitted
- 28 Mar 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Trial of XH001 (Neoantigen Cancer Vaccine) Sequential Combination With Immunocheckpoint Inhibitor and Chemotherapy in Adjuvant Therapy for Patients With Resected Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06353646
- Acronym / sponsor ID
- XKY-C-004
- Conditions
- Pancreatic Cancer
- Keywords
- cancer vaccine, mRNA, neoantigen, Pancreatic Cancer, adjuvant therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Wu WenmingUniversity, hospital or other
- Collaborators
- NeoCura
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: XH001, Drug: Ipilimumab Injection, Drug: ChemotherapyXH001;Ipilimumab Injection;Chemotherapy |
| Arm B | Experimental | Biological: XH001, Drug: Sintilimab injection, Drug: ChemotherapyXH001;Sintilimab Injection;Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XH001XH001 will be administered 12 weeks post-tumor resection (+/- 2 weeks) | Biological | Arm A, Arm B |
| Ipilimumab InjectionIpilimumab will be administered 12 weeks post-tumor resection (+/- 2 weeks) | Drug | Arm A |
| Sintilimab injectionSintilimab will be administered 12 weeks post-tumor resection (+/- 2 weeks) | Drug | Arm B |
| Chemotherapygemcitabine + capecitabine | Drug | Arm A, Arm B |
Primary outcome
DFS
Time frame: From operation up to 36 months
disease-free survival (DFS)
DFS rate
Time frame: DFS rate at 12,24, and 36 months after operation
disease-free survival rate
MFS
Time frame: From operation up to 36 months
metastasis-free survival (MFS)
OS
Time frame: From date of operation until the date of first documented date of death from any cause, assessed up to 36 months
overall survival (OS)
4 secondary outcomes
Elispot
Time frame: up to 36 months
Adverse Event
Time frame: up to 36 months
ctDNA
Time frame: up to 36 months
CA19-9
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenming WU, Prof. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XH001, Ipilimumab Injection and Sintilimab injection in people with Pancreatic Cancer, run by Wu Wenming 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 10 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. 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 Wenming 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?
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 13 Feb 2026.