Actively Recruiting
Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer
Led by Peking Union Medical College Hospital · Updated on 2024-07-10
45
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of irinotecan liposome II in combination with oxaliplatin and 5-FU/LV in perioperative treatment of borderline resectable pancreatic cancer in 45 patients.
CONDITIONS
Official Title
Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with borderline resectable pancreatic cancer according to NCCN Clinical Practice Guidelines (2024.V1 edition)
- Have at least one measurable tumor lesion based on RECIST v1.1
- No prior anti-tumor treatments including radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational drugs
- Have an ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Adequate organ and blood function
You will not qualify if you...
- Pancreatic cancers not originating from pancreatic ductal cells, including neuroendocrine carcinoma, acinar cell carcinoma, blastoma, or solid pseudopapillary tumor
- Severe gastrointestinal dysfunction
- Severe infection within 4 weeks before treatment (CTCAE grade above 2)
- Abnormal blood clotting, bleeding tendencies, or current thrombolytic/anticoagulant therapy
- Poorly controlled heart conditions such as NYHA grade 2 or higher heart failure, unstable angina, recent myocardial infarction within 6 months, or significant arrhythmias needing treatment
- Known allergies to irinotecan liposome II, liposome products, oxaliplatin, 5-FU, calcium leucovorin, or their components
- Known peripheral neuropathy of grade 3 or higher (CTCAE)
- Other serious medical conditions, mental illness, significant lab abnormalities, or social/family factors interfering with safety or data collection as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
W
Wenming Wu, doctor
CONTACT
+
+86 010-69156053 Wu, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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