Recruiting NCT06353646
XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XH001, Ipilimumab Injection, Sintilimab injection, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Biological XH001
XH001 will be administered 12 weeks post-tumor resection (+/- 2 weeks) - Drug Ipilimumab Injection
Ipilimumab will be administered 12 weeks post-tumor resection (+/- 2 weeks) - Drug Sintilimab injection
Sintilimab will be administered 12 weeks post-tumor resection (+/- 2 weeks) - Drug Chemotherapy
gemcitabine + capecitabine
Primary outcome measures
- DFS [Time frame: From operation up to 36 months]
- DFS rate [Time frame: DFS rate at 12,24, and 36 months after operation]
- MFS [Time frame: From operation up to 36 months]
- OS [Time frame: From date of operation until the date of first documented date of death from any cause, assessed up to 36 months]
Secondary outcome measures (4)
- Elispot [Time frame: up to 36 months]
- Adverse Event [Time frame: up to 36 months]
- ctDNA [Time frame: up to 36 months]
- CA19-9 [Time frame: up to 36 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT06353646 · XKY-C-004