Actively Recruiting
XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer
Led by Wu Wenming · Updated on 2026-02-13
28
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
Sponsors
W
Wu Wenming
Lead Sponsor
N
NeoCura
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Aged 18 to 75 years old
- Diagnosis of pancreatic adenocarcinoma confirmed by tissue analysis
- Completed R0 or R1 surgical resection as confirmed by pathology
- No prior neoadjuvant therapy received
- ECOG performance status of 0 or 1
- Life expectancy greater than 12 months
- CA19-9 level less than 100 U/mL before initial chemotherapy
- Adequate organ and marrow function based on laboratory tests
- Women of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines
You will not qualify if you...
- Borderline resectable pancreatic cancer
- Any evidence of disease recurrence or metastasis after surgery
- Presence of malignant ascites
- Pre-existing inflammatory bowel disease or bowel obstruction, or persistent severe diarrhea after surgery
- Need for long-term systemic anti-allergic medication or known allergy to study treatment components
- History of autoimmune disease
- New cerebrovascular accident within 6 months before screening
- Acute myocardial infarction within 6 months before screening or severe uncontrolled heart conditions
- Use of immunomodulatory medications within 4 weeks before first dose of XH001
- Blood transfusion or growth factor treatment within 7 days before first dose of XH001
- Prior therapeutic tumor vaccine treatment
- Congenital or acquired immunodeficiency
- Participation in other clinical trials without withdrawal before screening
- Inability or unwillingness to comply with study protocol due to health, mental, or social conditions
- Other conditions deemed inappropriate for participation by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
W
Wenming WU, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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