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Recruiting Phase 3

Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer

NCT07238283 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2025-12-02
Last updated
2025-12-09

Condition(s) studied

First-line Treatment of Metastatic Pancreatic Cancer

Investigational drug(s) / intervention(s)

Irinotecan Hydrochloride Liposome Injection (II); Oxaliplatin; 5Fluorouracil; Calcium folinateAll Irinotecan Hydrochloride Liposome trials (16) →All Oxaliplatin trials (330) →All 5Fluorouracil trials (9) →All Calcium folinate trials (18) →nab-paclitaxel; gemcitabineAll Nab-paclitaxel trials (233) →All Gemcitabine trials (386) →

Irinotecan Hydrochloride Liposome Injection (II); Oxaliplatin; 5Fluorouracil; Calcium folinate: Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate

nab-paclitaxel; gemcitabine: nab-paclitaxel in combination with gemcitabine

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Overall survival (OS) — From study start until target OS events have occurred (approximately 18 months after last patient enrollment)

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07238283 on ClinicalTrials.gov ↗ ← All trials in China