Pancreatic Adenocarcinoma MetastaticNALIRI-PANCNCT06006728
Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
An observational study of Pancreatic Adenocarcinoma Metastatic, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The objectives of the study are to evaluate the efficacy (primary endpoint: overall survival), safety (secondary endpoint) and the medico-economic impact (secondary endpoint) of nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid in clinical practice Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma Metastatic
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2023to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient treated with nanoliposomal irinotecan with fluorouracil and folinic acid for metastatic pancreatic adenocarcinoma after progression with gemcitabine-based treatment
Who may be able to join
- 18 years or older
- histological or cytological confirmation of pancreatic ductal adenocarcinoma
- measurable lesion(s)
- progression after gemcitabine-based treatment administered in a neoadjuvant, adjuvant protocol (only if remote metastases developed within 6 months of the end of adjuvant treatment), locally advanced, or metastatic phase. They may have already received irinotecan and/or fluorouracil.
- Performance Status (PS) 0 or 1
- Oral consent
- Health insurance
Who cannot join
- symptomatic brain metastases (cerebral edema, corticosteroids, progressive disease)
- thromboembolic events within six months of inclusion;
- Class III or IV congestive heart failure, ventricular arrhythmia, uncontrolled hypertension.
- Patient under legal protection
- Hypersensitivity to irinotecan
- Breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of the study are to evaluate the efficacy (primary endpoint: overall survival), safety (secondary endpoint) and the medico-economic impact (secondary endpoint) of nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid in clinical practice
Read the detailed description
Nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid was shown to be effective after gemcitabine-based treatment in patients with metastatic pancreatic adenocarcinoma in the phase III NAPOLI-1 randomized trial.
Nanoliposomal irinotecan is authorized in combination with 5-fluorouracil (5-FU) and leucovorin (LV), as it has shown an improvement in overall survival (median +1.9 months, HR = 0.67) compared to 5-FU/LV alone, without degradation of quality-of-life scales.
However, patients included in clinical trials regularly differ from patients in routine practice, and a real-life study is fundamental in this poor prognosis situation where quality of life preservation is paramount
- Conditions
- Pancreatic Adenocarcinoma Metastatic
- Keywords
- pancreatic adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| naliri | Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Up to 3 years
Secondary outcomes (3)
Response rate to treatment
Initial staging at the time of diagnosis is based on computed tomography (CT) or magnetic resonance imaging (MRI).
Duration of treatment is calculated from the day of nal-IRI initiation to the day of disease progression, switch to other treatment regimens or when the patient is lost to follow-up.
Tumor response is assessed by abdominal CT or MRI, according to the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) and CA19-9.
Measured: Every 3 months up to 3 years
Progression-free survival
Measured: Every 3 months up to 3 years
Cost evaluation
number of vials per patient
Measured: Every 3 months up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start6 Oct 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Adenocarcinoma MetastaticStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Servier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006728
- Sponsor's protocol ID
- CHUBX 2023/14
- Acronym
- NALIRI-PANC
- Status last verified
- Jan 2024
- First submitted
- 17 Aug 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Decraecker M, Le Joncour S, Aurillac V, Sangnier M, Ducerf C, Berroneau A, Rouleau L, Tougeron D, Laplace C, Madau M, Dumon C, Perrier H, Blanc JF. Real-world efficacy of nanoliposomal irinotecan in patients with advanced pancreatic cancer. BMC Cancer. 2025 Nov 28;26(1):3. doi: 10.1186/s12885-025-15346-8.
PubMed 41316032
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
- ClinicalTrials.gov ID
- NCT06006728
- Acronym / sponsor ID
- NALIRI-PANC / CHUBX 2023/14
- Conditions
- Pancreatic Adenocarcinoma Metastatic
- Keywords
- pancreatic adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Servier
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 23 Aug 2023 (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.
The objectives of the study are to evaluate the efficacy (primary endpoint: overall survival), safety (secondary endpoint) and the medico-economic impact (secondary endpoint) of nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid in clinical practice
Detailed description
Nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid was shown to be effective after gemcitabine-based treatment in patients with metastatic pancreatic adenocarcinoma in the phase III NAPOLI-1 randomized trial.
Nanoliposomal irinotecan is authorized in combination with 5-fluorouracil (5-FU) and leucovorin (LV), as it has shown an improvement in overall survival (median +1.9 months, HR = 0.67) compared to 5-FU/LV alone, without degradation of quality-of-life scales.
However, patients included in clinical trials regularly differ from patients in routine practice, and a real-life study is fundamental in this poor prognosis situation where quality of life preservation is paramount
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| naliri | – | –Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient treated with nanoliposomal irinotecan with fluorouracil and folinic acid for metastatic pancreatic adenocarcinoma after progression with gemcitabine-based treatment
Key inclusion criteria (7 listed)
- 18 years or older
- histological or cytological confirmation of pancreatic ductal adenocarcinoma
- measurable lesion(s)
- progression after gemcitabine-based treatment administered in a neoadjuvant, adjuvant protocol (only if remote metastases developed within 6 months of the end of adjuvant treatment), locally advanced, or metastatic phase. They may have already received irinotecan and/or fluorouracil.
- Performance Status (PS) 0 or 1
Key exclusion criteria (6 listed)
- symptomatic brain metastases (cerebral edema, corticosteroids, progressive disease)
- thromboembolic events within six months of inclusion;
- Class III or IV congestive heart failure, ventricular arrhythmia, uncontrolled hypertension.
- Patient under legal protection
- Hypersensitivity to irinotecan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: Up to 3 years
3 secondary outcomes
Response rate to treatment
Time frame: Every 3 months up to 3 years
Progression-free survival
Time frame: Every 3 months up to 3 years
Cost evaluation
Time frame: Every 3 months up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Derived from this study: PubMed 41316032Decraecker M, Le Joncour S, Aurillac V, Sangnier M, Ducerf C, Berroneau A, Rouleau L, Tougeron D, Laplace C, Madau M, Dumon C, Perrier H, Blanc JF. Real-world efficacy of nanoliposomal irinotecan in patients with advanced pancreatic cancer. BMC Cancer. 2025 Nov 28;26(1):3. doi: 10.1186/s12885-025-15346-8.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Adenocarcinoma Metastatic, run by University Hospital, Bordeaux at 1 site in France.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06006728, which also lists 1 linked publication.
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 12 Jan 2024.