RecruitingPhase 2NCT06387810

Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer

Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer:A Prospective, Single-arm, Multicenter, Phase II Study


Sponsor

Peking Union Medical College Hospital

Enrollment

45 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of irinotecan liposome II in combination with oxaliplatin and 5-FU/LV in perioperative treatment of borderline resectable pancreatic cancer in 45 patients.


Eligibility

Min Age: 18 YearsMax Age: 110 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination chemotherapy regimen (irinotecan liposome, 5-FU, leucovorin, and oxaliplatin) given before and after surgery for people with borderline resectable pancreatic cancer — meaning the tumor is close to but not yet invading nearby blood vessels, making surgery possible but risky. **You may be eligible if...** - Your pancreatic cancer has been classified as borderline resectable by NCCN guidelines - You have not received any prior cancer treatment (chemotherapy, radiation, or surgery for cancer) - You have adequate organ function and an ECOG performance score of 0 or 1 - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have a rare non-ductal type of pancreatic cancer (neuroendocrine, acinar, or blastoma) - You have severe digestive problems - You have had a serious infection in the past 4 weeks - You have significant heart problems (heart failure, unstable angina, or recent heart attack) - You are allergic to any components of the regimen - You are pregnant or breastfeeding 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 liposome II combined with 5-FU/LV and oxaliplatin

irinotecan liposome II: 60mg/m2, intravenously for at least 90min, D1, administered every 2 weeks; oxaliplatin: 85 mg/m2, intravenous infusion, D1, every 2 weeks; calcium leucovorin: 400 mg/m2, 30±10min intravenously, D1, every 2 weeks; 5-fluorouracil: 2400 mg/m2 intravenously for 46-48 hours or according to study Center clinical practice, D1, administered every 2 weeks. Irinotecan liposome II, oxaliplatin, LV and 5-FU were given successively, and corresponding prophylactic administration could be selected according to clinical needs.


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT06387810


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