De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma

NARecruitingINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

March 4, 2024

Primary Completion Date

February 1, 2026

Study Completion Date

February 1, 2028

Conditions
Nasopharyngeal CarcinomaRadiotherapy; ComplicationsIMMUNOTHERAPY
Interventions
RADIATION

de-escalated radiotherapy

Enrolled patients receive three courses of induction therapy with gemcitabine and cisplatin, along with Toripalimab. After induction therapy, patients with a tumor volume regression of 75% or more and no detectable EBV DNA will receive de-escalated radiotherapy for the primary tumor with 60 Gy. During radiotherapy, patients will receive Cisplatin 100 mg/m2 every three weeks for two courses and Toripalimab 240 mg every three weeks for three courses. If patients do not achieve complete remission at the end of radiotherapy, 6 Gy will be added to the residual lesions.

RADIATION

conventional radiotherapy

Enrolled patients receive three courses of induction therapy with gemcitabine and cisplatin, along with Toripalimab. After induction therapy, patients with tumor volume regression less than 75% or EBV DNA copy number higher than 0 receive conventional radiotherapy for the primary tumor with 70 Gy. Patients will receive Cisplatin 100 mg/m2, every three weeks for two courses during radiotherapy.

Trial Locations (1)

510060

RECRUITING

Sun Yat-Sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER