Clinical trialPhase 2Recruiting
Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial
- Outcome
- Ongoing
- Phase
- Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 5 March 2025
- Expected end
- 5 February 2028
- Enrollment
- 84 participants
- Sites
- 9
- Primary outcomes
- 12-month EFS rate
- Sponsor
- Other
- Results posted
- No
- Last update
- 20 February 2025
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Brief summary public domain (ClinicalTrials.gov)
To explore the safety and activity of NALIRIFOX (liposomal irinotecan in combination with fluorouracil, leucovorin, and oxaliplatin) in the perioperative and adjuvant treatment in resectable pancreatic adeneocarcinoma.
Detailed description public domain (ClinicalTrials.gov)
Adjuvant chemotherapy after surgery significantly improved the survival of pancreatic cancer patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesion which are not being detected in early disease status and improve the R0 resection rate. Additionally, it prevents unnecessary surgeries by selecting patients with rapid disease progression. Furthermore, compared with chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting. NALIRIFOX was approved its efficacy and safety in metastatic pancreatic cancer, but its role in perioperative setting is unknown. In this study, we want to o explore the safety and activity of NALIRIFOX in the perioperative and adjuvant treatment in resectable pancreatic adeneocarcinoma.