Clinical trial NCT06353646: XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Keywords: cancer vaccine, mRNA, neoantigen
Pancreatic Cancer
adjuvant therapy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: NeoCura
First posted: 2024-04-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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 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.

Primary outcomes:
measure: DFS
timeFrame: up to 36 months
measure: DFS rate
timeFrame: up to 36 months
measure: MFS
timeFrame: up to 36 months
measure: OS
timeFrame: From date of recruitment until the date of first documented date of death from any cause, assessed up to 36 months
Secondary outcomes:
measure: Elispot
timeFrame: up to 36 months
measure: Adverse Event
timeFrame: up to 36 months
measure: ctDNA
timeFrame: up to 36 months
measure: CA19-9
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Wenming WU, Prof.
role: PRINCIPAL_INVESTIGATOR
References: