New vaccine combo aims to stop pancreatic cancer return after surgery
NCT ID NCT06353646
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a personalized cancer vaccine (XH001) given after surgery for pancreatic cancer, followed by immunotherapy drugs (ipilimumab, sintilimab) and chemotherapy (gemcitabine + capecitabine). The goal is to see if this combination can prevent the cancer from coming back. The trial will enroll 28 adults who have had their tumor completely or nearly completely removed and have not had prior treatment. Researchers will track how long patients stay cancer-free and monitor side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- XH001 (neoantigen cancer vaccine), ipilimumab, sintilimab, gemcitabine, capecitabine
- What this could lead to
- If it works, this combination could help prevent pancreatic cancer from coming back after surgery, potentially extending survival.
- What could go wrong
- This is a very small, early-phase trial with only 28 people, so results may not apply broadly. The treatment involves multiple drugs with significant side effects, and the vaccine is experimental.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital
RECRUITINGBeijing, Beijing Municipality, 100730, China
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Other studies related to the condition(s) this trial covers.
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- Two oral drugs join chemotherapy in a bid to shrink pancreatic tumors
- Nerve-Block procedure tested against severe pancreatic and stomach cancer pain