PD-1 Blockade Combined With De-intensified Chemoradiotherapy Sparing Concurrent Cisplatin in Nasopharyngeal Carcinoma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

532

Participants

Timeline

Start Date

August 1, 2021

Primary Completion Date

March 1, 2025

Study Completion Date

March 1, 2027

Conditions
Nasopharyngeal Carcinoma
Interventions
DRUG

PD-1 blocking antibody

"1. IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 240 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. IMRT phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 240 mg, day 1; start on day 1 of IMRT or CCRT and continue every 3 weeks for 3 cycles till the end of IMRT.~3. Adjuvant PD-1 blocking antibody: every 3 weeks × 11 cycles; 240 mg, day 1"

DRUG

Gemcitabine

Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles

DRUG

Cisplatin (80mg/m2)

Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles

DRUG

Cisplatin (100mg/m2)

Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles

RADIATION

Intensity-modulated radiotherapy

Definitive IMRT of 70 Gy, 33 fractions, 5 fractions/week, 1 fraction/day

Trial Locations (12)

510060

Panyu central hospital, Guangzhou

Unknown

Beijing Cancer Hospital, Beijing

Chongqing Cancer Hospital, Chongqing

First People's Hospital of Foshan, Foshan

Cancer Hospital of Guangxi Medical University, Nanning

Cancer Hospital of Guizhou Medical University, Guiyang

Hubei Province Cancer Hosiptal, Wuhan

Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology, Wuhan

Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology, Wuhan

Xiangya Hospital Central South University, Changsha

Jiangxi Province Cancer Hospital, Nanchang

Zhejiang Province Cancer Hospital, Hangzhou

All Listed Sponsors
collaborator

Shanghai Junshi Bioscience Co., Ltd.

OTHER

lead

Sun Yat-sen University

OTHER