Based on the superior efficacy and safety profile of liposomal irinotecan over irinotecan in pancreatic cancer, as well as preliminary results from earlier studies evaluating nab-paclitaxel and gemcitabine (AG) combined with liposomal irinotecan, this study aims to further evaluate the efficacy and safety of liposomal irinotecan plus AG as neoadjuvant therapy in patients with resectable or borderline resectable pancreatic cancer (RPC/BRPC). The ultimate goal is to identify a more effective treatment regimen to prolong overall survival in this patient population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Neoadjuvant therapy: SHR-1701 1800mg every 4-week cycle
Neoadjuvant therapy: liposomal irinotecan injection (II) 60mg/m²+ nab-paclitaxel 125mg/m²+ gemcitabine 1000mg/m²+ every 4-week cycle,during which radical surgery will be evaluated by the investigator.
The First Hospital of Jilin University
Changchun, Jilin, China
R0 Resection Rate
Percentage of participants who undergo radical surgical resection and achieve an R0 margin status (defined as microscopically negative surgical margins with no tumor cells at the resection edge, \>1 mm margin clearance).
Time frame: approximately 16 to 20 weeks post-enrollment
Resection Rate
Percentage of participants who undergo surgical resection following neoadjuvant therapy.
Time frame: approximately 16 to 20 weeks post-enrollment
pCR rate
Percentage of participants who achieve a pathological complete response (defined as the complete absence of active tumor cells in the resected surgical specimen including primary tumor and regional lymph nodes, i.e., ypT0yN0).
Time frame: approximately 16 to 20 weeks post-enrollment
EFS
Event-Free Survival
Time frame: Up to 18 months
OS
overall survive
Time frame: Up to 36 months
ORR
Objective Response Rate
Time frame: From enrollment to the end of neoadjuvant therapy (approximately 16 weeks)
DCR
Disease Control Rate
Time frame: From enrollment to the completion of neoadjuvant therapy (approximately 16 weeks)
safety
Incidence, severity, and causality of adverse events (AEs), serious adverse events (SAEs), and clinical laboratory abnormalities assessed according to NCI-CTCAE v5.0.
Time frame: From baseline up to 30 days post-surgery or post-last dose
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