Clinical trialPhase 2Not yet recruiting
Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX
NALIRIFOX as Perioperative Treatment in Patients With High-risk Resectable Pancreatic Cancer : a Multicenter, Randomized, Open-label Trial
- Outcome
- Ongoing
- Phase
- Phase 2
- Status
- Not yet recruiting
- Study type
- Interventional
- Start
- 1 February 2024
- Expected end
- 1 April 2027
- Enrollment
- 134 participants
- Sites
- 0
- Primary outcomes
- 2-year Overall Survival Rate
- Sponsor
- Other
- Results posted
- No
- Last update
- 18 January 2024
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Brief summary public domain (ClinicalTrials.gov)
This multicentric randomized trial will compare the efficacy and safety of neoadjuvant chemotherapy + surgery + adjuvant chemotherapy or surgery + adjuvant chemotherapy in patients with high-risk resectable pancreatic cancer. NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) will be used as the chemotherapy regimen.
Detailed description public domain (ClinicalTrials.gov)
Liposomal irinotecan is a new pharmaceutical form of traditional irinotecan. It adopts a special loading technology to encapsulate traditional irinotecan in liposomes, which can avoid its hydrolysis under physiological conditions, increase the affinity with cancer cells, overcome drug resistance, increase the drug uptake by cancer cells, reduce the drug dose,improve the efficacy and reduce the toxic side effects. The aim of this study is to compare the efficacy and safety of NALIRIFOX + surgery + NALIRIFOX or surgery + NALIRIFOX in high-risk patients with resectable pancreatic cancer.