Resectable Pancreatic AdenocarcinomaPhase 2NCT06816914
Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial
A Phase 2 study testing NALIRIFOX in people with Resectable Pancreatic Adenocarcinoma, run by Taichung Veterans General Hospital at 9 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Resectable Pancreatic Adenocarcinoma
- What is being tested?
- NALIRIFOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 9 sitesTaiwan
- Study dates
- 5 Mar 2025to 5 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- previously untreated, histologically or cytologically proven PDAC
- age between 20 and 75 years at registration
- ECOG performance status of 0 or 1
- AJCC (8th edition) clinical stage I or II with measurable disease (CT or MRI) in the pancreas. (positron emission tomography scan alone not allowed)
- Surgically resectable disease according to NCCN criteria (Version 1.2023 - May 4, 2023):
- no arterial tumor contact (celiac axis, superior mesentery artery, or common hepatic artery).
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- no tumor contact with the superior mesentery vein or portal vein or ≤180° contact without vein contour irregularity.
- adequate major organ functions
- Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) must agree to use contraception from the time ofinformed consent until 6 months or more after the last dose of investigational products. Also, women must agree not to breastfeed from the time of informed consent until 6 months or more after the last dose of the investigational product.
- Men must agree to use contraception from the start of study treatment until 3 months or more after the last dose of the investigational product.
- Participants must have signed written informed consent form in accordance with regulatory and institutional guidelines.
Who cannot join
- presence of clinically significant co-morbid medical conditions within 4 weeks prior registration judged by Investigators
- severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in past 6 months
- New York Heart Association class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure or known abnormal electrocardiogram (ECG) with clinically significant abnormal findings in past 6 months
- interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity within 28 days prior to registration
- presence of diarrhea ≥ CTCAE v.5.0 grade 2
- concomitant systemic infection requiring treatment
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- prior organ allograft or allogeneic bone marrow transplantation
- known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome
- prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer
- any major surgery within 4 weeks of study treatment. Participants must have recovered from the effects of major surgery or significant traumatic injury at least 4 weeks before study treatment.
- pregnant women or nursing mothers, or positive pregnancy tests
- severe mental disorder
- current use or any use in past 2 weeks of strong cytochrome P450 3A4 enzyme inducers/inhibitors and/or strong UGT1A inhibitors
- known hypersensitivity to any of the components of study drugs
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Taiwan9 sites, 9 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Yen-Yang Chen, MD, PhD, 886-07-7317123, tnet0901@gmail.com
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Shih-Chang Chuang, 886-07-3121101, chuangsc@cc.kmu.edu.tw
- Recruiting
China Medical University Hospital
Taichung
Li-Yuan Bai, MD, PhD, 886-04-22053366, lybai6@gmail.com
- Recruiting
Taichung Veterans General Hospital
Taichung
Hsin-Chen Lin, MD, 886-23592525 ext. 3175, jawlin15@hotmail.com
- Recruiting
National Cheng Kung University Hospital
Tainan
Yan-Shen Shan, MD, PhD, 886-6-2353535 ext. 5000, ysshan@mail.ncku.edu.tw
- Recruiting
National Taiwan University Hospital
Taipei
Ching-Yao Yang, MD, PhD, 886-02-23220322, cyang@ntuh.gov.tw
- Recruiting
Taipei Veterans General Hospital
Taipei
Nai-Jung Chiang, MD, PhD, 886-02-28749425, njchiang@vghtpe.gov.tw
- Recruiting
Tri-Service General Hospital
Taipei
Shiue-Wei Lai, 886-02-87923311, xsurfer@mail.ndmctsgh.edu.tw
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan
Chun-Nan Yeh, 886-03-3281200, ycn@cgmh.org.tw
About this study
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.
Read the detailed description
Adjuvant chemotherapy after surgery significantly improved the survival of pancreatic cancer patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesion which are not being detected in early disease status and improve the R0 resection rate. Additionally, it prevents unnecessary surgeries by selecting patients with rapid disease progression. Furthermore, compared with chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting. NALIRIFOX was approved its efficacy and safety in metastatic pancreatic cancer, but its role in perioperative setting is unknown. In this study, we want to o explore the safety and activity of NALIRIFOX in the perioperative and adjuvant treatment in resectable pancreatic adeneocarcinoma.
- Conditions
- Resectable Pancreatic Adenocarcinoma
- Being tested
- NALIRIFOX
- Keywords
- Perioperative, NALIRIFOX, resectable pancreatic adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NALIRIFOXDrug
Patient in upfront surgery arm will receive operation followed by adjuvant chemotherapy with NALIRIFOX; patient in experimental arm will receive neoadjuvant NALIRIFOX followed by operation than adjuvant NALIRIFOX after operation.
| Study group | Role | What they receive |
|---|---|---|
| Upfront surgery | Active comparator | Patient in upfront surgery arm will receive operation followed by adjuvant chemotherapy with NALIRIFOX Receives: Drug: NALIRIFOX |
| Perioperative NALIRIFOX | Experimental | Patient in experimental arm will receive neoadjuvant NALIRIFOX followed by operation than adjuvant NALIRIFOX after operation. Receives: Drug: NALIRIFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month EFS rate
Measured: From enrollment to the event in 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start5 Mar 2025 (estimated)
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, Taipei Veterans General Hospital, Taiwan, National Taiwan University Hospital, China Medical University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Tri-Service General Hospital (TSGH)
- Responsible party
- Principal investigator, Hsin-Chen Lin, Taichung Veterans General Hospital
- Investigators
- Yan-Shen Shan, MD, PhD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816914
- Sponsor's protocol ID
- SF24596A
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT06816914
- Acronym / sponsor ID
- SF24596A
- Conditions
- Resectable Pancreatic Adenocarcinoma
- Keywords
- Perioperative, NALIRIFOX, resectable pancreatic adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, Taipei Veterans General Hospital, Taiwan, National Taiwan University Hospital, China Medical University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Tri-Service General Hospital (TSGH)
- Study start
- 5 Mar 2025 (estimated)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Feb 2028 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adjuvant chemotherapy after surgery significantly improved the survival of pancreatic cancer patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesion which are not being detected in early disease status and improve the R0 resection rate. Additionally, it prevents unnecessary surgeries by selecting patients with rapid disease progression. Furthermore, compared with chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting. NALIRIFOX was approved its efficacy and safety in metastatic pancreatic cancer, but its role in perioperative setting is unknown. In this study, we want to o explore the safety and activity of NALIRIFOX in the perioperative and adjuvant treatment in resectable pancreatic adeneocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upfront surgery | Active comparator | Drug: NALIRIFOXPatient in upfront surgery arm will receive operation followed by adjuvant chemotherapy with NALIRIFOX |
| Perioperative NALIRIFOX | Experimental | Drug: NALIRIFOXPatient in experimental arm will receive neoadjuvant NALIRIFOX followed by operation than adjuvant NALIRIFOX after operation. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- previously untreated, histologically or cytologically proven PDAC
- age between 20 and 75 years at registration
- ECOG performance status of 0 or 1
- AJCC (8th edition) clinical stage I or II with measurable disease (CT or MRI) in the pancreas. (positron emission tomography scan alone not allowed)
- Surgically resectable disease according to NCCN criteria (Version 1.2023 - May 4, 2023):
Key exclusion criteria (14 listed)
- presence of clinically significant co-morbid medical conditions within 4 weeks prior registration judged by Investigators
- severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in past 6 months
- New York Heart Association class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure or known abnormal electrocardiogram (ECG) with clinically significant abnormal findings in past 6 months
- interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity within 28 days prior to registration
- presence of diarrhea ≥ CTCAE v.5.0 grade 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NALIRIFOXPatient in upfront surgery arm will receive operation followed by adjuvant chemotherapy with NALIRIFOX; patient in experimental arm will receive neoadjuvant NALIRIFOX followed by operation than adjuvant NALIRIFOX after operation. | Drug | Perioperative NALIRIFOX, Upfront surgery |
Primary outcome
12-month EFS rate
Time frame: From enrollment to the event in 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan-Shen Shan, MD, PhD principal investigator
National Cheng-Kung University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NALIRIFOX in people with Resectable Pancreatic Adenocarcinoma, run by Taichung Veterans General Hospital at 9 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan-Shen Shan, MD, PhD (886-6-2353535 ext. 5000, ysshan@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month EFS rate (time frame: From enrollment to the event in 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.