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Trial Title:
XH001 Combination With Ipilimumab and Chemotherapy for Patients With Resected Pancreatic Cancer
NCT ID:
NCT06353646
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Ipilimumab
Conditions: Keywords:
cancer vaccine, mRNA, neoantigen
Pancreatic Cancer
adjuvant therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
XH001
Description:
mRNA neoantigen cancer vaccine
Arm group label:
XH001 (dose 1)
Arm group label:
XH001 (dose 2)
Intervention type:
Drug
Intervention name:
Ipilimumab Injection
Description:
a type of immunotherapy that targets CTLA-4 protein on T cells
Arm group label:
XH001 (dose 1)
Arm group label:
XH001 (dose 2)
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
gemcitabine + capecitabine
Arm group label:
XH001 (dose 1)
Arm group label:
XH001 (dose 2)
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
ipilimumab and chemotherapy in pancreatic cancer patients following surgical resection.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Start date:
April 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Wu Wenming
Agency class:
Other
Collaborator:
Agency:
NeoCura
Agency class:
Industry
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06353646
