The First Hospital of Jilin University
Changchun, Jilin, China
NCT Number: NCT07806110
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 2
Changchun, Jilin, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: approximately 16 to 20 weeks post-enrollment
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
Percentage of participants who undergo surgical resection following neoadjuvant therapy.
Time frame: approximately 16 to 20 weeks post-enrollment
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: Up to 18 months
Event-Free Survival
Time frame: Up to 36 months
overall survive
Time frame: From enrollment to the end of neoadjuvant therapy (approximately 16 weeks)
Objective Response Rate
Time frame: From enrollment to the completion of neoadjuvant therapy (approximately 16 weeks)
Disease Control Rate
Time frame: From baseline up to 30 days post-surgery or post-last dose
Incidence, severity, and causality of adverse events (AEs), serious adverse events (SAEs), and clinical laboratory abnormalities assessed according to NCI-CTCAE v5.0.
The First Hospital of Jilin University
Other
A Prospective, Phase II Study of Gemcitabine and Nab-paclitaxel in Combination With Liposomal Irinotecan (II) With or Without SHR-1701 as Neoadjuvant Therapy for Resectable/Borderline Resectable Pancreatic Cancer.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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