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
62
Tislelizumab 200mg administered intravenously on Days 1 of every 3 weeks.
Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1 \& 8 of every 3 weeks.
Gemcitabine 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
RECRUITINGObjective Response Rate (ORR)
RECIST Version 1.1
Time frame: Up to 2 years
R0 resection rate
R0 resection rate
Time frame: Up to 1 years
Median Progression Free Survival (mPFS)
RECIST Version 1.1
Time frame: Up to 2 years
Median Overall survival (mOS)
RECIST Version 1.1
Time frame: Up to 2 years
Disease control rate (DCR)
RECIST Version 1.1
Time frame: Up to 2 years
Pathological grade of tumor tissue after neoadjuvant therapy
Pathological grade of tumor tissue after neoadjuvant therapy
Time frame: Up to 1 years
Adverse Events
Adverse event (AE)、Serious adverse event (SAE)
Time frame: Up to 2 years
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Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy\*10 fractions, Planning target volume (PTV) 3Gy\*10 fractions.