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New treatment option for Pancreatic Cancer
Official title XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer
ClinicalTrials.gov ID: NCT06353646
What this study is testing
What is XH001?
XH001 is an investigational medicine, being studied as a potential treatment for pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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;
You likely can't join 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;
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.