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Metastatic Adenocarcinoma of the PancreasPhase 2NCT06225999

Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas

A Phase 2 study testing Irinotecan liposome injection (S095013), Oxaliplatin and LLV (levoisomer form of leucovorin) in people with Metastatic Adenocarcinoma of the Pancreas, run by Institut de Recherches Internationales Servier at 14 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to assess the anti-tumour activity, safety and tolerability of irinotecan liposome injection (S095013) in combination with oxaliplatin, 5-Fluorouracil (5-FU) and levoisomer form of leucovorin (LLV). S095013, oxaliplatin, 5-FU and LLV will be administered on days 1 and 15 of each 28-day cycle. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Irinotecan liposome injection (S095013), Oxaliplatin and LLV (levoisomer form of leucovorin)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
14 sitesJapan
Study dates
25 Apr 2024to 29 Sep 2025
Phase
Phase 2
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

Who may be able to join

  • Male or non-pregnant and non-lactating female ≥ 18 years of age.
  • Histologically or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting.
  • Initial diagnosis of metastatic disease (as per American Joint Committee on Cancer 8th Edition [AJCC 2017]) must have occurred ≤ 6 weeks prior to screening.
  • Participant has one or more metastatic lesions measurable by CT-scan (or MRI), if the participant is allergic to CT contrast media, according to RECIST Version 1.1 criteria.
  • ECOG PS of 0 or 1 at screening and within 7 days prior to first dosing.
  • Participant has adequate hematological, biochemical, hepatic, and renal function parameters.

Who cannot join

  • Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy (palliative surgery, palliative radiotherapy and placement of biliary stent/tube are permitted).
  • Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related relevant toxicities are present.
  • Participant has only locally advanced disease.
  • Known hypersensitivity to any of the components of irinotecan liposome injection, other liposomal products, or any components of 5-FU, LLV or oxaliplatin products.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Japan14 sites

  • Chiba University Hospital (015)

    Chiba, 260-8677

  • Chiba Cancer Center (011)

    Chiba, 260-8717

  • National Hospital Organization Shikoku Cancer Center (013)

    Ehime, 791-0280

  • National Hospital Organization Kyushu Cancer Center (005)

    Fukuoka, 811-1395

  • Kanazawa University Hospital (008)

    Ishikawa, 920-8641

  • Kanagawa Cancer Center (002)

    Kanagawa, 241-8515

  • National Cancer Center Hospital East (003)

    Kashiwa, Chiba, 277-8577

  • Aichi Cancer Center (007)

    Nagoya, 464-8681

  • Osaka International Cancer Institute (009)

    Osaka, 541-8567

  • Saitama Cancer Center (012)

    Saitama, 362-0806

  • Hokkaido University Hospital (004)

    Sapporo, 060-8648

  • National Cancer Center Hospital (001)

    Tokyo, 104-0045

  • The Cancer Institute Hospital of JFCR (006)

    Tokyo, 135-8550

  • Yamaguchi University Hospital (010)

    Yamaguchi, 755-8505

Other trials in Japan

About this study

Official title: A Single-arm Multicentre Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Who Have Not Previously Received Therapy for Metastatic Adenocarcinoma of the Pancreas

This study is to assess the anti-tumour activity, safety and tolerability of irinotecan liposome injection (S095013) in combination with oxaliplatin, 5-Fluorouracil (5-FU) and levoisomer form of leucovorin (LLV). S095013, oxaliplatin, 5-FU and LLV will be administered on days 1 and 15 of each 28-day cycle. Cycles will continue until clinical or radiological progressive disease, unacceptable study medication-related toxicity or withdrawal from study. During the treatment period participants will have study visits on day 1, 3, 15, and 17 of each cycle, some of which may occur as a home visit. At least 30 days after treatment has ended a end of treatment visit will occur and then participants will be followed for survival every month via telephone or email until death or end of the study. Study visits may include questionnaires, blood and urine tests, ECG, vital signs, physical examination, and administration of study treatment.

Being tested
Irinotecan liposome injection (S095013), Oxaliplatin, LLV (levoisomer form of leucovorin), 5- FU (5-Fluorouracil)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Irinotecan liposome injection (S095013)Drug

    Also called MM-398, Nal-IRI, BAX2398, PEP02

    Irinotecan liposome injection (S095013) will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.

  • OxaliplatinDrug

    Oxaliplatin will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.

  • LLV (levoisomer form of leucovorin)Drug

    LLV will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.

  • 5- FU (5-Fluorouracil)Drug

    5-FU will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.

Study groups in NCT06225999
Study groupRoleWhat they receive
Irinotecan liposome Injection in combination with oxaliplatin, 5-FU and LLVExperimentalNot described
Receives: Drug: Irinotecan liposome injection (S095013); Drug: Oxaliplatin; Drug: LLV (levoisomer form of leucovorin); Drug: 5- FU (5-Fluorouracil)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response (OR)

    OR is defined as complete response (CR) or partial response (PR), as assessed by the independent central review (ICR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.

    Measured: Through the end of study treatment (approximately 16 months after study start)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2024
  2. Study start25 Apr 2024
  3. Primary completion28 Apr 2025
  4. Study completion29 Sep 2025

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06225999
Sponsor's protocol ID
S095013-169
Status last verified
May 2026
First submitted
17 Jan 2024
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Publications

  • Ikeda M, Okusaka T, Ueno M, Ozaka M, Satoi S, Skanji D, Martin-Fernandez L, Amellal N, Furuse J. NALIRIFOX in Japanese treatment-naive patients with metastatic pancreatic adenocarcinoma: an open-label, phase II trial design. Future Oncol. 2025 Apr;21(8):959-965. doi: 10.1080/14796694.2025.2469467. Epub 2025 Feb 22.

    PubMed 39987459

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan liposome injection (S095013), Oxaliplatin and LLV (levoisomer form of leucovorin) in people with Metastatic Adenocarcinoma of the Pancreas, run by Institut de Recherches Internationales Servier at 14 sites in Japan.

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 6 inclusion and 4 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Japan. 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?

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 Response (OR) (time frame: Through the end of study treatment (approximately 16 months after study start)). 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 NCT06225999, 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 18 May 2026.

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