593
Participants
Start Date
March 1, 2024
Primary Completion Date
February 20, 2027
Study Completion Date
February 20, 2030
PD-1 blocking antibody
"1. IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 200 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC.~2. Adjuvant PD-1 blocking antibody: every 3 weeks × 9 cycles; 200 mg, day 1."
Gemcitabine
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.
Cisplatin (80 mg/m2)
Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.
Reduced-dose Intensity-modulated radiotherapy
"1. Definitive IMRT, 30 fractions, 5 fractions/week, 1 fraction/day~2. Radiotherapy dose: pGTV: 6360cGy/30F; pCTV1: 5460cGy/30F; pCTV2: 4920cGy/30F."
Conventional-dose Intensity-modulated radiotherapy
"1. Definitive IMRT, 33 fractions, 5 fractions/week, 1 fraction/day~2. Radiotherapy dose: pGTV: 6996cGy/33F; pCTV1: 6006cGy/33F; pCTV2: 5412cGy/33F."
Cisplatin (100 mg/m2)
Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles
Capecitabine
Metronomic adjuvant capecitabine chemotherapy: 650 mg/m2 p.o. bid, 1 year, adminstration starts immediately after concurrent chemoradiotherapy.
NOT_YET_RECRUITING
Hunan Cancer Hospital, Changsha
RECRUITING
Sun Yat-Sen University Cancer Center, Guangzhou
NOT_YET_RECRUITING
Zhongshan city Peaple's Hospital, Zhongshan
NOT_YET_RECRUITING
Cancer Hospital of Guangxi Medical University, Nanning
NOT_YET_RECRUITING
Cancer Hospital of Guizhou Medical University, Guiyang
NOT_YET_RECRUITING
Hubei Province Cancer Hosiptal, Wuhan
NOT_YET_RECRUITING
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology, Wuhan
NOT_YET_RECRUITING
Xiangya Hospital Central South University, Changsha
Jiangsu Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Sun Yat-sen University
OTHER