XH001 (New Antigen Tumor Vaccine) Combined With Chemotherapy as Adjuvant Therapy in Pancreatic Cancer
Not Applicable
Not yet recruiting
- Conditions
- Pancreatic Cancer
- Interventions
- Drug: Chemotherapy
- Registration Number
- NCT07114666
- Lead Sponsor
- Peking Union Medical College Hospital
- 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) in combination with chemotherapy as Adjuvant Therapy in pancreatic cancer patients following surgical resection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Provision of signed and dated informed consent form;
- Aged 18 to 75 years old;
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma;
- R0 or R1 surgical resection as determined by pathology；
- Have not received any prior neoadjuvant therapy;
- ECOG score is 0 or 1;
- 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 metastasis or disease recurrence 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;
- 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
- PARALLEL
- Arm && Interventions
Group Intervention Description XH001 (dose 1) XH001 Biological: XH001 * mRNA neoantigen cancer vaccine（Dose 1） Drug: Chemotherapy * gemcitabine+capecitabine * oxaliplatin+lrinotecan+calcium folinate+5-FU XH001 (dose 1) Chemotherapy Biological: XH001 * mRNA neoantigen cancer vaccine（Dose 1） Drug: Chemotherapy * gemcitabine+capecitabine * oxaliplatin+lrinotecan+calcium folinate+5-FU XH001 (dose 2) XH001 Biological: XH001 * mRNA neoantigen cancer vaccine(Dose 2) Drug: Chemotherapy * gemcitabine+capecitabine * oxaliplatin+lrinotecan+calcium folinate+5-FU XH001 (dose 2) Chemotherapy Biological: XH001 * mRNA neoantigen cancer vaccine(Dose 2) Drug: Chemotherapy * gemcitabine+capecitabine * oxaliplatin+lrinotecan+calcium folinate+5-FU
- Primary Outcome Measures
Name Time Method DFS From operation up to 36 months Disease Free Survival
DFS Rate 12,24 and 36 months Disease-free survival rate
MFS up to 36 months metastasis-free survival
OS up to 48 months Overall survival
- Secondary Outcome Measures
Name Time Method Adverse Event up to 36 months Incidence and severity of adverse events (AEs), clinically significant abnormal changes in laboratory tests and other examinations (based on the Criteria for the Evaluation of Adverse Events \[CTCAE\] v5.0).
Specific immune response up to 36 months Antigen-specific T-cell responses
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, China
Peking Union Medical College Hospital🇨🇳Beijing, China