The purpose of the study is to evaluate the efficacy and safety of NALIRINOX combined with PD-1 synchronous sequential SBRT or AG combined with PD-1 synchronous sequential SBRT as first line systematical therapy in patients with ocally advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
These drugs are given on d1, d15, 28 days as one cycle. 6-6 treatment cycles. SBRT is performed in third cycles.
These drugs are given on d1, d8, 21 days as one cycle. 6-6 treatment cycles. SBRT is performed in third cycles.
FirstNanjingMU
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
RECRUITINGmPFS
Time from randomization to disease progression and/or death.
Time frame: Up to 12 months
mOS
Time from randomization to death
Time frame: Up to 24 months
ORR
According to RECIST version 1.1, the proportion of patients who achieved remission (PR+CR) after treatment and maintained the minimum time-frame requirement.
Time frame: Up to 12 months
DCR
According to RECIST version 1.1, the proportion of patients who achieved remission (PR+CR) and stable lesion (SD) after treatment and maintained the minimum time-frame requirements.
Time frame: Up to 12 months
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