The purpose of this study is to determine the safety and tolerance of sitagliptin combined with gemcitabine and albumin-bound paclitaxel in subjects with locally advanced and metastatic pancreatic ductal adenocarcinoma.
This is a single-institution, prospective, open, one-armed phase Ⅱ clinical trial of sitagliptin combined with gemcitabine and nab-paclitaxel. This study will enroll 30 PDAC patients over 12-15 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Drug1: Sitagliptin will be administered orally once a day at a dose of 100 mg depending on cohort assignment. Drug2: Gemcitabine will be intravenously administered on Days 1 and 8 of every 21-day cycle at a dose of 1000 mg/m2 depending on cohort assignment. Drug3: Nab-Paclitaxel will be intravenously administered on Days 1 and 8 of every 28-day cycle at a dose of 125 mg/m2 depending on cohort assignment.
Progression-free survival time
Rrogression-free survival time of PDAC patients
Time frame: from start of treatment until progression or last known follow up (i.e up to 2 years)
Objective Response Rate
Objective Response Rate
Time frame: from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years) Using RECIST 1.1
Frequency of adverse events in the safety evaluable population
Frequency of adverse events in the safety evaluable population
Time frame: Time Frame: from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years)
Median Overall Survival (mOS) of the treated population
Median Overall Survival (mOS) of the treated population
Time frame: from start of treatment until death or last known follow up (i.e up to 2 years)
Disease control rate (DCR)
Disease control rate (DCR)
Time frame: 8 weeks
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