NCT07238283RecruitingPhase 3
Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer
Irinotecan Hydrochloride Liposome Injection (II) in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Nab-paclitaxel in Combination With Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
This study is a randomized, open-label, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of Irinotecan Hydrochloride Liposome Injection (II) combined with oxaliplatin and 5-FU/LV versus nab-paclitaxel combined with gemcitabine as first-line treatment for advanced pancreatic cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 662 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 2 Dec 2025
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Pancreatic cancer
- NCT number
- NCT07238283
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 662
- From 2 Dec 2025 to the primary completion date, 31 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
- Known history of central nervous system (CNS) metastases.
- 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.
Who the study is looking for
- ECOG performance status 0 or 1
- Histological or cytologically confirmed pancreatic cancer that has not been previously treated in the metastatic disease.
- Life expectancy of greater than or equal to3 months.
- At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)
- Able and willing to provide a written informed consent
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.