This study is a randomized, open-label, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of Irinotecan Hydrochloride Liposome Injection (II) combined with oxaliplatin and 5-FU/LV versus nab-paclitaxel combined with gemcitabine as first-line treatment for advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
662
Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate
nab-paclitaxel in combination with gemcitabine
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGOverall survival (OS)
Time frame: From study start until target OS events have occurred (approximately 18 months after last patient enrollment)
Objective Response rate (ORR)
ORR is defined as the percentage of participants who have a best overall response of complete response (CR) or partial response (PR), per RECIST 1.1.
Time frame: up to 6 months following the date the last patient was randomized
Disease Control Rate
The study is designed to evaluate the disease control rate with advanced pancreatic cancer. DCR is defined as the percentage of patients with a best response of CR, PR, or stable disease (SD).
Time frame: up to 6 months following the date the last patient was randomized
Duration of Response
DoR is defined as the time from first documentation of response (CR or PR whichever occurred first, as per RECIST version 1.1) to disease progression or death, whichever is earlier.
Time frame: up to 6 months following the date the last patient was randomized
Progression free survival (PFS)
PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first.
Time frame: From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first,assessed up to 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.