Actively Recruiting
Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial
Led by Taichung Veterans General Hospital · Updated on 2025-02-20
84
Participants Needed
9
Research Sites
152 weeks
Total Duration
On this page
Sponsors
T
Taichung Veterans General Hospital
Lead Sponsor
N
National Cheng-Kung University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
To explore the safety and activity of NALIRIFOX (liposomal irinotecan in combination with fluorouracil, leucovorin, and oxaliplatin) in the perioperative and adjuvant treatment in resectable pancreatic adeneocarcinoma.
CONDITIONS
Official Title
Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously untreated, histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)
- Age between 20 and 75 years at registration
- ECOG performance status of 0 or 1
- Clinical stage I or II pancreatic cancer with measurable disease by CT or MRI
- Surgically resectable disease per NCCN criteria with no arterial tumor contact and limited vein involvement
- Adequate major organ function
- Women of childbearing potential must agree to use contraception from consent until 6 months after last dose and avoid breastfeeding
- Men must agree to use contraception from treatment start until 3 months after last dose
- Signed informed consent form according to regulatory and institutional guidelines
You will not qualify if you...
- Clinically significant co-morbid medical conditions within 4 weeks before registration
- Severe arterial thromboembolic events in past 6 months (myocardial infarction, unstable angina, stroke)
- NYHA class III or IV heart failure, ventricular arrhythmias, uncontrolled blood pressure, or significant ECG abnormalities in past 6 months
- Symptomatic interstitial lung disease or lung disease interfering with treatment monitoring within 28 days prior
- Diarrhea of grade 2 or higher by CTCAE v5.0
- Systemic infection needing treatment
- Prior organ transplant or allogeneic bone marrow transplant
- Known HIV infection or AIDS
- Prior or other cancers within last 3 years except cervical carcinoma in situ or basal cell skin cancer
- Major surgery within 4 weeks before study treatment without full recovery
- Pregnant or nursing women or positive pregnancy test
- Severe mental disorder
- Use of strong cytochrome P450 3A4 enzyme inducers/inhibitors or strong UGT1A inhibitors in past 2 weeks
- Known allergy to any study drug components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
3
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
4
Taichung Veterans General Hospital
Taichung, Taiwan
Actively Recruiting
5
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
6
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
7
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
8
Tri-Service General Hospital
Taipei, Taiwan
Actively Recruiting
9
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Actively Recruiting
Research Team
Y
Yan-Shen Shan, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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