Toripalimab Vs. Placebo Wtih GP Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

466

Participants

Timeline

Start Date

February 17, 2025

Primary Completion Date

January 1, 2030

Study Completion Date

January 1, 2032

Conditions
Nasopharyngeal Carcinoma (NPC)
Interventions
DRUG

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"

DRUG

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"

Trial Locations (1)

510060

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

collaborator

Guangxi Medical University Cancer Center

UNKNOWN

collaborator

Affiliated Hospital of Guangdong Medical University

OTHER

collaborator

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

OTHER

collaborator

The University of Hong Kong-Shenzhen Hospital

OTHER

collaborator

Hunan Cancer Hospital

OTHER

collaborator

The Affiliated Cancer Hosipital of Guizhou Meidical University

UNKNOWN

collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

collaborator

Fujian Cancer Hospital

OTHER_GOV

lead

Sun Yat-sen University

OTHER