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Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:
Evaluate the Efficacy and Safety of Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer: a Phase Ib/II, Multicenter, Open-label Trial

Clinical Trial Summary

This multicentric open-label trial will compare the efficacy and safety of stereotactic body radiation therapy (SBRT) followed by NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) vs NALIRIFOX for borderline resectable pancreatic cancer (BRPC).

Clinical Trial Description

Neoadjuvant chemotherapy or chemoradiotherapy can increase the R0 resection rate and improve survival in BRPC. However, there is no standard treatment regimen. The National Comprehensive Cancer Network (NCCN) guidelines recommend FOLFIRINOX (irinotecan + oxaliplatin +5-FU/LV) and FOLFIRINOX+ chemoradiotherapy for PDAC neoadjuvant treatment. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06259058
Study type Interventional
Source Tianjin Medical University Cancer Institute and Hospital
Contact Chuntao Gao, Professor
Phone 022-2340123
Email gaochuntao@tjmuch.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date April 1, 2024
Completion date December 1, 2027
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