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Reduced-dose Versus Conventional-dose Intensity-modulated Radiation Therapy for Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and Immunotherapy
Sponsor: Ming-Yuan Chen
Summary
To explore the efficacy and safety of reduced-dose radiotherapy combined with concurrent chemotherapy and immunotherapy in stage Ⅳa (AJCC 8th,) locally advanced nasopharyngeal carcinoma patients who are sensitive to induction chemoimmunotherapy (assessed as complete response \[CR\]/partial response \[PR\] by imaging, with EBV DNA copy number reduced to zero or below the lower limit of detection), so as to provide a new treatment option for these patients.
Official title: Reduced-Dose Versus Conventional-Dose Intensity-Modulated Radiation Therapy in Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and Immunotherapy: A Multicenter, Phase III Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
456
Start Date
2025-11-18
Completion Date
2032-06-30
Last Updated
2026-01-09
Healthy Volunteers
No
Conditions
Interventions
Full course of PD-1blockades
Toripalimab 240 mg, once every 3 weeks (Q3W), intravenous infusion (iv). A total of 12 courses of treatment will be administered, including 3 courses during the induction chemotherapy phase, 3 courses during the radiotherapy phase, and 6 courses during the post-radiotherapy maintenance phase. Administration will start on Day 1 of induction chemotherapy and continue after the end of radiotherapy until the occurrence of intolerable toxicities, disease progression, withdrawal of consent, determination by the investigator that the patient needs to withdraw from treatment, or the completion of 12 courses, whichever comes first.
Cisplatin-based induction chemotherapy
Cisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy.
Standard-dose radiotherapy
GTVnx/nd:69.96Gy/33Fr/2.12Gy CTV1: 59.4Gy/33Fr/1.8Gy CTV2: 54.12Gy/33Fr/1.64Gy
Reduced-dose radiotherapy
GTVnx/nd:63.6Gy/30Fr/2.12Gy CTV1: 54Gy/30Fr/1.8Gy CTV2: 49.2Gy/30Fr/1.64Gy
Concurrent Chemotherapy
Cisplatin 100mg/m2 every 3 weeks for 2 cycles
Locations (12)
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China
Sun Yat-sen University cancer center
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Sun Yat-sen University (SYSU)
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Central South University Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Guangdong, Zhuhai, China