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Clinical Trial Summary

This is a prospective, single arm, single center, phase II study of NALIRIFOX as conversion therapy in patients with locally advanced pancreatic cancer.


Clinical Trial Description

Subjects will be treated with the NALIRIFOX regimen every 2 weeks in 4-weeks cycles Imaging of tumor lesions will be performed after the subject has completed the first 2 cycles of treatment, and if the subject has not progressed, the subject will continue treatment until surgical resection, disease progression (RECIST 1.1) or intolerable toxicity, start of new anticancer drug therapy, withdrawal from the study, death, or loss to follow-up. All treated subjects will be evaluated for response while on this treatment every 8 weeks (±7) days after until surgical resection, disease progression (RECIST 1.1), intolerable toxicity, start of new anticancer drug therapy, withdrawal from the study, death, or loss to follow-up.. After 24 weeks of treatment, capecitabine or S-1 is the maintenance regimen. Radiographic response will be evaluated every 12 weeks (± 7 days) during the maintenance phase. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06467565
Study type Interventional
Source The First Affiliated Hospital with Nanjing Medical University
Contact Rong K Jiang, MD
Phone +8615312995688
Email jiangkuirong@njmu.edu.cn
Status Recruiting
Phase Phase 2
Start date December 25, 2023
Completion date December 31, 2025

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