Actively Recruiting
Perioperative NALIRIFOX (liposomal Irinotecan 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
52 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
This research aims to evaluate the safety and activity of NALIRIFOX, a combination of liposomal irinotecan with fluorouracil, leucovorin, and oxaliplatin, for patients with resectable pancreatic adenocarcinoma. The study explores whether giving this treatment around the time of surgery (perioperative) is effective and safe compared to surgery followed by chemotherapy. Pancreatic cancer patients often face challenges completing chemotherapy after surgery, so this study also investigates whether giving chemotherapy before surgery helps control hidden cancer spread and improves surgical outcomes. Participants are randomly assigned to one of two groups. One group undergoes surgery first, followed by adjuvant chemotherapy with NALIRIFOX. The second group receives neoadjuvant chemotherapy with NALIRIFOX before surgery, then continues with adjuvant NALIRIFOX chemotherapy after the operation. This randomized Phase II trial compares these approaches to understand the best timing for delivering NALIRIFOX in this setting. During the study, participants will be closely monitored for treatment effects, surgery outcomes, and disease progression. Researchers will assess the 12-month event-free survival rate from enrollment to any event within a year. Participants will have scans such as CT or MRI to measure disease status, along with evaluations of organ function and overall health. The study includes safety monitoring, and participants will be followed from enrollment through treatment and recovery phases, lasting up to several years as needed.
CONDITIONS
Brief 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 by AJCC (8th edition) with measurable disease in pancreas by CT or MRI
- Surgically resectable disease following NCCN criteria without arterial tumor contact and limited vein contact
- Adequate major organ functions
- Women of childbearing potential must use contraception from consent until 6 months after last dose and not breastfeed
- Men must use contraception from start of treatment until 3 months after last dose
- Signed informed consent form according to regulations
You will not qualify if you...
- Clinically significant co-morbid medical conditions within 4 weeks before registration
- Severe arterial thromboembolic events (heart attack, unstable angina, stroke) within past 6 months
- NYHA class III or IV heart failure, ventricular arrhythmias, uncontrolled blood pressure, or significant abnormal ECG within past 6 months
- Symptomatic interstitial lung disease or conditions interfering with pulmonary toxicity management within 28 days before registration
- Diarrhea of grade 2 or higher
- Active systemic infections requiring treatment
- Prior organ transplant or allogeneic bone marrow transplant
- Known HIV infection or AIDS
- Other cancers within last 3 years except cervical carcinoma in situ or basal skin cancer
- Major surgery within 4 weeks before study treatment; must have recovered
- Pregnant or nursing women, or positive pregnancy test
- Severe mental disorder
- Use of strong cytochrome P450 3A4 or UGT1A inhibitors/inducers within last 2 weeks
- Known allergy to study drug components
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Perioperative period including neoadjuvant and adjuvant phases
Participants receive NALIRIFOX chemotherapy before and/or after surgery depending on their assigned group.
Duration - Single surgical event with immediate recovery period
Participants undergo surgery to remove pancreatic cancer tumors.
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
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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