Actively Recruiting
A Study of NALIRIFOX in Combination With Radiation Therapy in People With Pancreatic Ductal Adenocarcinoma (PDAC)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-06-05
60
Participants Needed
7
Research Sites
155 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
I
Ipsen
Collaborating Sponsor
AI-Summary
What this Trial Is About
The researchers are doing this study to find out whether using the chemotherapy regimen NALIRIFOX in combination with ablative dose radiation therapy (AD-XRT) and the standard chemotherapy drug capecitabine is an effective treatment approach for people with locally advanced or borderline resectable pancreatic ductal adenocarcinoma (PDAC) before surgery. This type of treatment approach is called total neoadjuvant therapy (TNT). The researchers will also look at whether the sequence of the treatment approach (NALIRIFOX + ADXRT and capecitabine followed by surgery, when it is possible) is effective and causes few or mild side effects in participants. An important purpose of the study is to see how the study treatment (NALIRIFOX + AD-XRT and capecitabine) affects participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires
CONDITIONS
Official Title
A Study of NALIRIFOX in Combination With Radiation Therapy in People With Pancreatic Ductal Adenocarcinoma (PDAC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study activities
- History of other cancers allowed if disease-free for at least 2 years or specific low-risk cancers treated within 5 years
- Multidisciplinary plan for total neoadjuvant therapy and potential surgery documented
- Male or nonpregnant, nonlactating female aged 18 years or older
- Women of childbearing potential must have a negative pregnancy test at screening
- Female participants of reproductive potential must use two effective birth control methods during and 9 months after study
- Male participants must use condoms during and 4 months after study
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma not previously treated
- Radiographic evidence of borderline resectable or locally advanced pancreatic cancer without distant metastases
- Inoperable status after surgery due to locally advanced disease without metastases allowed if recovered
- ECOG performance status of 0 or 1
- Adequate blood counts: ANC ≥1500/mm³, platelets ≥100,000/mm³
- INR below 1.5 unless on anticoagulation with therapeutic INR
- Adequate kidney function: creatinine level below 1.6 mg/dL
You will not qualify if you...
- Metastatic pancreatic cancer (M1 disease)
- Any medical or social condition preventing informed consent, cooperation, or participation
- Unwilling or unable to follow study procedures or visits
- Medical conditions preventing major abdominal surgery
- Histology other than adenocarcinoma (except adenosquamous variants)
- Prior chemotherapy, abdominal radiotherapy, or definitive pancreatic cancer surgery
- Neuropathy greater than grade 2
- Pregnant or nursing
- Uncontrolled active infection except resolving cholangitis deemed safe by investigator
- Known allergy to any chemotherapy components
- Participation in other investigational therapy within 30 days before study start
- For immunoPET sub-study: previous severe allergic reaction to antibodies or inability to tolerate scanning (e.g., claustrophobia)
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
A
Alice Wei, MD
CONTACT
E
Eileen O'Reilly, MD
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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