RecruitingPhase 3NCT07238283

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.


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

662 participants

Start Date

Dec 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy regimens as first-line treatment for pancreatic cancer that has spread to other parts of the body (metastatic). One combination includes a newer liposomal (special encapsulated) form of a drug called irinotecan combined with oxaliplatin and a standard chemo regimen, compared to a standard gemcitabine-plus-nab-paclitaxel regimen. **You may be eligible if...** - You have been diagnosed with pancreatic cancer that has spread and have not yet received chemotherapy for this stage - You are in reasonably good physical condition (ECOG score 0 or 1) - Doctors expect you to live at least 3 months or longer - You have at least one measurable tumor on imaging scans - You are willing and able to give written consent **You may NOT be eligible if...** - Your pancreatic cancer is a rare subtype like neuroendocrine, acinar cell, pancreatoblastoma, or solid-pseudopapillary tumor - You have cancer that has spread to the brain - You have a serious active infection requiring IV antibiotics - You have significant heart problems (heart failure, recent heart attack, uncontrolled irregular heartbeat, or unstable angina) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIrinotecan Hydrochloride Liposome Injection (II); Oxaliplatin; 5Fluorouracil; Calcium folinate

Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate

DRUGnab-paclitaxel; gemcitabine

nab-paclitaxel in combination with gemcitabine


Locations(1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT07238283