GAPP Induction and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance for Nasopharyngeal Carcinoma.

PHASE2RecruitingINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

January 3, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Nasopharyngeal Carcinoma
Interventions
DRUG

Toripalimab

"Fixed dose: 240mg/ time, add 100ml normal saline, intravenous infusion for 30 minutes (not less than 20 minutes, not more than 60 minutes).~The first course of induction chemotherapy (D1) is used on the first day of each cycle, and every 21 days is a course of treatment up to 18 courses or one year.~After intravenous infusion of triplelizumab, GP regimen induction chemotherapy was administered at an interval of 30-60 minutes."

DRUG

Anlotinib

"Oral administration before breakfast, 10mg/ time/day, once a day (d1-14), repeated every 3 weeks, using three courses, one week before radiotherapy discontinuation.~Use on the day the first course of induction chemotherapy begins (D1)."

DRUG

Gemcitabine

"1000mg/m2, D1, D8, add 0.9% normal saline 500ml, intravenous infusion. Every 21 days is a treatment cycle. If the recovery of toxicity in the subject is not sufficient for the next course of chemotherapy, the start of the next course of chemotherapy may be appropriately delayed, but the delay cannot exceed 21 days.~The treatment was continued for 3 courses."

DRUG

Cisplatin

"Induction Chemotherapy: 80mg/m2, D1, add 1000ml 0.9% normal saline, intravenous infusion for 3 hours.~Concurrent Chemoradiotherapy100mg/m2, add 5% glucose 500ml, intravenous drip. Use on the first day of each cycle, every 21 days for a treatment cycle"

RADIATION

radiation

IMRT, 33Fx

Trial Locations (1)

510060

RECRUITING

Sun yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER