Combining a cancer vaccine with immunotherapy and chemotherapy for pancreatic cancer patients after surgery

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 study is testing a new cancer vaccine combined with immunotherapy and chemotherapy to see if it helps prevent pancreatic cancer from coming back in patients who have had surgery to remove their tumors.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06353646 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of XH001, a neoantigen cancer vaccine, in combination with immunocheckpoint inhibitors and chemotherapy for patients who have undergone surgical resection of pancreatic cancer. It is a single-center, open-label, and single-arm study, meaning all participants will receive the same treatment without a control group. The goal is to determine how well this combination therapy works in preventing cancer recurrence in patients who have had their tumors surgically removed. Participants will be closely monitored for their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed pancreatic adenocarcinoma who have undergone R0 or R1 surgical resection and have not received prior neoadjuvant therapy.

Not a fit: Patients with borderline resectable pancreatic cancer or evidence of disease recurrence or metastasis will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve survival rates and reduce the risk of cancer recurrence in patients with resected pancreatic cancer.

How similar studies have performed: While the combination of immunotherapy and chemotherapy has shown promise in other cancers, this specific approach in pancreatic cancer is relatively novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Wenming WU, Prof. — Peking Union Medical College Hospital
• Study coordinator: Wenming WU, Prof.

Conditions Pancreatic Cancer; cancer vaccine, mRNA, neoantigen; adjuvant therapy