XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer
Not Applicable
Recruiting
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT06353646
- Lead Sponsor
- Wu Wenming
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A XH001 XH001;Ipilimumab Injection;Chemotherapy Arm A Ipilimumab Injection XH001;Ipilimumab Injection;Chemotherapy Arm A Chemotherapy XH001;Ipilimumab Injection;Chemotherapy Arm B XH001 XH001;Sintilimab Injection;Chemotherapy Arm B Sintilimab injection XH001;Sintilimab Injection;Chemotherapy Arm B Chemotherapy XH001;Sintilimab Injection;Chemotherapy
- Primary Outcome Measures
Name Time Method DFS up to 36 months disease-free survival (DFS)
DFS rate up to 36 months disease-free survival rate
MFS up to 36 months metastasis-free survival (MFS)
OS From date of recruitment until the date of first documented date of death from any cause, assessed up to 36 months overall survival (OS)
- Secondary Outcome Measures
Name Time Method Elispot up to 36 months Antigen-specific T-cell responses in peripheral blood
Adverse Event up to 36 months 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).
ctDNA up to 36 months Changes of ctDNA compared to baseline
CA19-9 up to 36 months Changes of CA19-9 compared to baseline
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China