New liposomal irinotecan combo takes on pancreatic cancer in major trial
NCT ID NCT07238283
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase III trial is testing whether a new combination of drugs (irinotecan liposome, oxaliplatin, 5-fluorouracil, and calcium folinate) works better than the current standard treatment (nab-paclitaxel plus gemcitabine) for people with metastatic pancreatic cancer who haven't had prior treatment. About 662 participants will be enrolled across multiple centers. The main goal is to see if the new combo helps people live longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Irinotecan hydrochloride liposome injection (II) combined with oxaliplatin, 5-fluorouracil, and calcium folinate
- What this could lead to
- If this works, it could offer a new first-line treatment option for metastatic pancreatic cancer, potentially improving survival compared to current standard therapy.
- What could go wrong
- This is a large Phase III trial, but the new combo may not prove better or safer than the existing regimen. Pancreatic cancer is very hard to treat, so even if successful, benefits may be modest.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 662 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 to 75 years
- 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: 1. ECOG performance status 0 or 1 2. Histological or cytologically confirmed pancreatic cancer that has not been previously treated in the metastatic disease. 3. Life expectancy of greater than or equal to3 months. 4. At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1) 5. Able and willing to provide a written informed consent Exclusion Criteria: 1. Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor; 2. Known history of central nervous system (CNS) metastases. 3. Severe infection (\> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment; 4. Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, Beijing Municipality, 100730, China
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Other studies related to the condition(s) this trial covers.
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- Can removing liver tumors alongside the whipple procedure extend life in stage IV pancreatic cancer?
- Can a One-Two punch of radiation and immunotherapy tame pancreatic cancer?
- Can three common drugs boost chemotherapy against pancreatic cancer?
- Smart drug delivers chemo directly to pancreatic cancer cells