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.
>18 years of age
Histologically proven pancreatic ductal adenocarcinoma, poorly differentiated carcinoma, or adenosquamous carcinoma
Radiographic evidence of metastatic disease
At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
None
Single group
NALIRIFOX
DrugNALIRIFOX 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
Gemcitabine plus nab-Paclitaxel (GnP)
DrugGnP consists of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2, given on Days 1, 8, and 15.
Determine 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.
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
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
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
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.
Click on the lead sponsor to view all of their trials.
