1
The Comprehensive Cancer Center of Drum Tower Hospital, Medical School of Nanjing University, Nanjing 210008, China.
2
The Comprehensive Cancer Center of Drum Tower Hospital, Medical School of Nanjing University, Nanjing 210008, China; Nanjing Drum Tower Hospital Clinical College of Nanjing University of Chinese Medicine, Nanjing 210008, China.
3
Department of Hepatopancreatobiliary Surgery, Drum Tower Hospital, Medical School of Nanjing University, Nanjing 210008, China.
4
Digestive Department of Drum Tower Hospital, Medical School of Nanjing University, Nanjing 210008, China.
5
Imaging Department of Drum Tower Hospital, Medical School of Nanjing University, Nanjing 210008, China.
6
Pathology Department of Drum Tower Hospital, Medical School of Nanjing University, Nanjing 210008, China.
7
Nuclear Medicine Department of Drum Tower Hospital, Medical School of Nanjing University, Nanjing 210008, China.
8
Nanjing Drum Tower Hospital Clinical College of Nanjing University of Chinese Medicine, Nanjing 210008, China.
9
National Institute of Healthcare Data Science at Nanjing University, Nanjing 210008, China.
10
The State Key Laboratory of Translational Medicine and Innovative Drug Development, Medical Department, Jiangsu Simcere Diagnostics Co., Ltd., Nanjing 210002, China.
11
Digestive Department of Drum Tower Hospital, Medical School of Nanjing University, Nanjing 210008, China. Electronic address: [email protected].
12
Department of Hepatopancreatobiliary Surgery, Drum Tower Hospital, Medical School of Nanjing University, Nanjing 210008, China. Electronic address: [email protected].
13
The Comprehensive Cancer Center of Drum Tower Hospital, Medical School of Nanjing University, Nanjing 210008, China. Electronic address: [email protected].
This is a phase II study of PD-1 blockade plus chemoradiotherapy as preoperative therapy for patients with locally advanced or borderline resectable pancreatic cancer (LAPC or BRPC, respectively). Twenty-nine patients are enrolled in the study. The objective response rate (ORR) is 60%, and the R0 resection rate is 90% (9/10). The 12-month progression-free survival (PFS) rate and 12-month overall survival (OS) rate are 64% and 72%, respectively. Grade 3 or higher adverse events are anemia (8%), thrombocytopenia (8%), and jaundice (8%). Circulating tumor DNA analysis reveals that patients with a >50% decline in maximal somatic variant allelic frequency (maxVAF) between the first clinical evaluation and baseline have a longer survival outcome and a higher response rate and surgical rate than those who are not. PD-1 blockade plus chemoradiotherapy as preoperative therapy displays promising antitumor activity, and multiomics potential predictive biomarkers are identified and warrant further verification.
