Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC

PHASE3RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 30, 2020

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2026

Conditions
Nasopharyngeal Carcinoma
Interventions
DRUG

PD-1 antibody

neoadjuvant: PD-1 inhibitor Toripalimab 240mg combined with neoadjuvant chemotherapy by cis Platinum and gemcitabine every 3 weeks for 3 cycles ; adjuvant: Toripalimab 240mg every 3 weeks for 9 cycles after concurrent chemoradiotherapy

DRUG

Gemcitabine

neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles

DRUG

Cisplatin

neoadjuvant chemotherapy: 80mg/m2 in day 1, and repeats every 3 weeks for 3 cycles. Concurrent chemoradiotherapy: Cisplatin 100mg/m2 in day 1, 22, and 43 during IMRT

RADIATION

IMRT

70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions

Trial Locations (7)

330029

RECRUITING

Jiangxi Cancer Hospital, Nanchang

RECRUITING

Pingxiang Peoples' Hospital, Pingxiang

332000

RECRUITING

Jiujiang University Affiliated Hospital, Jiujiang

341000

RECRUITING

Ganzhou Cancer Hospital, Ganzhou

RECRUITING

First Affiliated hospital of Gannan Medical University, Guangzhou

350014

RECRUITING

Fujian Cancer Hospital, Fuzhou

Unknown

RECRUITING

Suizhou Central Hospital, Suizhou

All Listed Sponsors
lead

Jiangxi Provincial Cancer Hospital

OTHER