The objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.
Due to the hidden onset and rapid progression of pancreatic cancer, most patients are already locally advanced or have distant metastasis at the time of diagnosis and lose the opportunity for surgery. Even among operable patients, about 50% will have recurrence and metastasis one year after surgery. Therefore, more and more evidence supports neoadjuvant therapy for patients with high risk factors for resectable pancreatic cancer, and conversion therapy followed by surgery for patients with borderline resectable and locally advanced pancreatic cancer. Therefore, the objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Toripalimab 240mg administered intravenously on Days 1 of every 3 weeks
Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1 \& 8 of every 3 weeks
Nab paclitaxel 125 mg/m\^2 administered intravenously on Days 1 \& 8 of every 3 weeks.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
ORR
RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1
Time frame: 2 years
R0 resection rate
R0 resection rate
Time frame: 2 years
os
OS is defined as the time from randomization to death due to any cause.
Time frame: 3 years
pfs
PFS is defined as the time from the first day of randomization to the date of first record of disease progression or death.
Time frame: 3 years
dcr
DCR including CR, PR, and SD
Time frame: 3 years
Adverse Events
Adverse event (AE)、Serious adverse event (SAE)
Time frame: 3 years
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SBRT Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy\*10 fractions, Planning target volume (PTV) 3Gy\*10 fractions