A prospective, interventional, single-center, single-arm, open-label, phase II study for patients with metastatic pancreatic cancer. The intervention consists of monthly alternating standard chemotherapy regimens-NALIRIFOX and GnP. The hypothesis is that induction therapy with alternating NALIRIFOX and GnP has better efficacy compared to historical observation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
NALIRIFOX consists of 5-FU 2400 mg/m2 over 46 hours, liposomal irinotecan 50 mg/m2, and oxaliplatin 60 mg/m2, which would be given on Day 1 and Day 15
GnP consists of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2, given on Days 1, 8, and 15.
Zuckerberg Cancer Center
New Hyde Park, New York, United States
RECRUITINGDetermine 6-month Progression Free Survival (PFS)
The primary endpoint is 6-month PFS rate defined as the proportion of patients alive and progression free (by RECIST v.1.1) at 6 months after treatment initiation. PFS events will be classified as either local progression, distant recurrence, secondary malignancy, or death.
Time frame: 6 months
Overall Response Rate
Overall response rate, defined as the proportion of patients whose best response is partial response or complete response by RECIST v.1.1
Time frame: 24 months
Disease Control Rate
Disease control rate, defined as the proportion of patients whose best response is stable disease, partial response, or complete response, by RECIST v.1.1
Time frame: 24 months
Overall Survival
OS, defined as the time from treatment initiation to death. Patients living without disease progression will be censored at the date of last assessment
Time frame: 24 months
Determine Toxicities using the NCI CTCAE v. 5.0
AEs will be monitored, and the incidence, severity, and relationship to study drug will be reported.
Time frame: 24 months
Time to Treatment Failure
Time to treatment failure, defined as the time from treatment initiation to discontinuation of treatment, either due to progression or intolerance
Time frame: 24 months
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