This is a single-center, open-label, randomized Phase 2 trial to evaluate the efficacy of NALIRIFOX (Arm 1) vs mGAP (Arm 2) in previously untreated patients with locally advanced (unresectable) and metastatic pancreatic ductal adenocarcinoma (PDAC).
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged ≥18 years
For females of reproductive potential: use of highly effective contraception for at least 1 month before screening and agreement to use such a method during study participation and for an additional 9 months after the end of the last dose of study medication administration
Pregnancy or lactation
Treatment with another investigational drug or other intervention within 30 days of protocol initiation.
Known hypersensitivity/allergic reaction to any of the components of the therapeutic agents in mGAP or NALIRIFOX.
Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, and participate in the study or who is likely to interfere with the interpretation of the results.
Sequential
Liposomal Irinotecan
Drug50 mg/m2 will be administered on Day 1 of a 2-week cycle
Oxaliplatin
Drug60 mg/m2 will be administered on Day 1 of a 2-week cycle
5-Fluorouracil
Drug5-fluorouracil (2400 mg/m2 over 46 hours) will begin administration on Day 1 of a 2-week cycle
Leucovorin
Drug400 mg/m2 will be administered on Day 1 of a 2-week cycle
Gemcitabine (mg/m²)
Drug1000 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle
Nab-paclitaxel
Drug125 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle
Cisplatin
Drug25 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle
Overall response rate (ORR) assessed by imaging.
Overall response rate (ORR) defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by imaging completed every 8 weeks.
Best overall response (BOR) assessed by imaging.
Best overall response (BOR) defined as a patient's best response across all response evaluations by RECIST v1.1 (CR, PR, stable disease \[SD\], or progressive disease \[PD\]) as assessed by imaging completed every 8 weeks.
Duration of response (DOR).
Duration of response (DOR) defined as the time interval between first evaluation of CR or PR and the first occurrence of progression or death due to any cause.
Disease control rate (DCR).
Disease control rate (DCR) defined as the proportion of patients with a best overall response of CR, PR or SD.
Progression-free survival (PFS).
Progression-free survival (PFS) defined as the time from randomization to progression or death due to any cause.
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