Reduced-dose RT With/Without CCT Versus Standard CCRT for High-risk LANPC Who Achieved CR Post Induction Chemotherapy

PHASE3RecruitingINTERVENTIONAL
Enrollment

504

Participants

Timeline

Start Date

October 9, 2023

Primary Completion Date

October 30, 2029

Study Completion Date

October 30, 2031

Conditions
Nasopharyngeal CarcinomaDe-escalation Therapy
Interventions
DRUG

Cisplatin-based induction chemotherapy

Cisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy including GP, TP, and TPF regimen.

DRUG

Full course of PD-1/PD-L1 blockades

a) Camrelizumab 200mg, b) Toripalimab 240mg, or c) Adebrelimab 1200mg will be started on day 1 of induction chemotherapy and given every 3 weeks for up to 12 cycles, or until intolerable toxicity, or disease progression or withdrawal from the treatment.

RADIATION

Reduced-dose IMRT

GTVnx:60Gy/30F/2.0Gy,CTV1:54Gy/30F/1.8Gy,CTV2:48Gy/30F/1.6Gy

RADIATION

Standard-dose IMRT

GTVnx:69.96Gy/33Fr/2.12Gy;CTV1:60.60Gy/33Fr/1.82y;CTV2:54.12Gy/33Fr/1.64Gy

DRUG

Concurrent Chemotherapy

Cisplatin 100mg/m2 every 3 weeks for 2 cycles

Trial Locations (1)

510060

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

collaborator

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

collaborator

Guangdong Provincial People's Hospital

OTHER

collaborator

Second Affiliated Hospital, Sun Yat-Sen University

OTHER

collaborator

The fifth Affiliated Hospital of Guangzhou Medcial University

OTHER_GOV

collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

collaborator

Hunan Cancer Hospital

OTHER

collaborator

Tongji Hospital

OTHER

lead

Sun Yat-sen University

OTHER