New cocktail of four chemo drugs shows promise for tough pancreatic cancer
NCT ID NCT06225999
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tested a combination of four chemotherapy drugs—irinotecan liposome, oxaliplatin, 5-fluorouracil, and levoleucovorin—in 41 Japanese adults with metastatic pancreatic cancer who had not received prior treatment. The goal was to see how well the drugs shrank tumors and to check safety. Participants received the drugs by IV on days 1 and 15 of each 28-day cycle until the disease worsened or side effects became too severe. The study is complete, and results may help guide future treatment options for this aggressive cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- irinotecan liposome, oxaliplatin, 5-fluorouracil, and levoleucovorin
- What this could lead to
- If this drug combination works well, it could offer a new first-line treatment option for people with metastatic pancreatic cancer, potentially improving tumor shrinkage and survival.
- What could go wrong
- This is a small, early-phase study with only 41 participants, so results may not apply to everyone. The drugs can cause serious side effects, and the combination may not prove better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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41 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aichi Cancer Center (007)
Nagoya, 464-8681, Japan
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Chiba Cancer Center (011)
Chiba, 260-8717, Japan
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Chiba University Hospital (015)
Chiba, 260-8677, Japan
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Hokkaido University Hospital (004)
Sapporo, 060-8648, Japan
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Kanagawa Cancer Center (002)
Kanagawa, 241-8515, Japan
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Kanazawa University Hospital (008)
Ishikawa, 920-8641, Japan
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National Cancer Center Hospital (001)
Tokyo, 104-0045, Japan
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National Cancer Center Hospital East (003)
Kashiwa, Chiba, 277-8577, Japan
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National Hospital Organization Kyushu Cancer Center (005)
Fukuoka, 811-1395, Japan
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National Hospital Organization Shikoku Cancer Center (013)
Ehime, 791-0280, Japan
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Osaka International Cancer Institute (009)
Osaka, 541-8567, Japan
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Saitama Cancer Center (012)
Saitama, 362-0806, Japan
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The Cancer Institute Hospital of JFCR (006)
Tokyo, 135-8550, Japan
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Yamaguchi University Hospital (010)
Yamaguchi, 755-8505, Japan
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