466
Participants
Start Date
February 17, 2025
Primary Completion Date
January 1, 2030
Study Completion Date
January 1, 2032
TORIPALIMAB INJECTION (JS001 ) combine with GP chemotherapy
"Drug: Toripalimab 240mg will be given every 3 weeks for 3 cycles, started on day 1 of induction chemotherapy.~Other Names:~JS001 PD-1 antibody~Drug: Gemcitabine 1000mg/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.~Drug: Cisplatin Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 3 cycles during radiation~Other Names:~DDP~Radiation: intensity-modulated radiotherapy Definitive intensity-modulated radiotherapy (IMRT) of 70 Gy will be given in 33 fractions.~Other Names:~IMRT"
GP plus placebo induction therapy
"Drug: Placebo 240mg will be given every 3 weeks for 3 cycles, started on day 1 of induction chemotherapy.~Drug: Gemcitabine 1000mg/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.~Drug: Cisplatin Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 3 cycles during radiation~Other Names:~DDP Radiation: intensity-modulated radiotherapy Definitive intensity-modulated radiotherapy (IMRT) of 70 Gy will be given in 33 fractions.~Other Names:~IMRT"
RECRUITING
Sun Yat-sen University Cancer Center, Guangzhou
First Affiliated Hospital of Guangxi Medical University
OTHER
Guangxi Medical University Cancer Center
UNKNOWN
Affiliated Hospital of Guangdong Medical University
OTHER
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
OTHER
The University of Hong Kong-Shenzhen Hospital
OTHER
Hunan Cancer Hospital
OTHER
The Affiliated Cancer Hosipital of Guizhou Meidical University
UNKNOWN
Sichuan Cancer Hospital and Research Institute
OTHER
Fujian Cancer Hospital
OTHER_GOV
Sun Yat-sen University
OTHER