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RECRUITING
NCT07328841
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

Cisplatin-based induction chemotherapy

Cisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy.

RADIATION

Standard-dose radiotherapy

GTVnx/nd:69.96Gy/33Fr/2.12Gy CTV1: 59.4Gy/33Fr/1.8Gy CTV2: 54.12Gy/33Fr/1.64Gy

RADIATION

Reduced-dose radiotherapy

GTVnx/nd:63.6Gy/30Fr/2.12Gy CTV1: 54Gy/30Fr/1.8Gy CTV2: 49.2Gy/30Fr/1.64Gy

DRUG

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