The study is being conducted to: a) evaluate the tolerability and safety of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer, and establish a maximum tolerated dose and recommended phase II dose of the combination and b) assess the efficacy of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of participants with a dose limited toxicity
Number of participants with a dose limited toxicity
Time frame: 28 Days (first and second cycle)
Maximum tolerated dose
Maximum tolerated dose
Time frame: Up to 8 months
RP2D
Recommended Phase 2 Dose
Time frame: Up to 8 months
R0 resection rate
R0 resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer
Time frame: Up to 2 years
AEs
Incidence of adverse events and associated dose of Fluzoparib
Time frame: From the first drug administration to within 30 days for the last drug dose
Resection Rate
Resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer
Time frame: Up to 2 years
MPR Rate
Major pathological response rate based on central review
Time frame: Up to 2 years
Objective response rate
Objective response rate
Time frame: Up to 2 years
Disease-free-survival
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Disease-free-survival
Time frame: Up to 2 years
Event-Free-Survival
Event-Free-Survival
Time frame: Up to 2 years
Overall-Survival
Overall-Survival
Time frame: Up to 2 years
Minimum concentration (Cmin)
Minimum observed plasma concentration for Fluzoparib
Time frame: Up to 2 years