RecruitingPhase 3NCT07328841

Reduced-dose Versus Conventional-dose Intensity-modulated Radiation Therapy for Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and Immunotherapy

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


Sponsor

Ming-Yuan Chen

Enrollment

456 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients with locally advanced nasopharyngeal cancer (cancer in the upper throat behind the nose) who respond very well to initial chemotherapy and immunotherapy can receive a lower dose of radiation therapy — with the aim of reducing side effects while maintaining the same cancer control. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with stage III or IVa nasopharyngeal cancer confirmed by biopsy - You have completed 3 cycles of platinum-based chemotherapy combined with immunotherapy, and your tumor has responded very well (complete or partial response confirmed on MRI and scope) - Your Epstein-Barr virus (EBV) DNA levels have dropped to undetectable after induction chemotherapy - Your blood counts and organ function are in acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs or recurred after prior treatment - Your tumor has not responded sufficiently to the initial chemotherapy and immunotherapy - Your EBV DNA levels remain elevated after induction treatment - You have poor overall health (ECOG score above 1) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFull 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.

DRUGCisplatin-based induction chemotherapy

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

RADIATIONStandard-dose radiotherapy

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

RADIATIONReduced-dose radiotherapy

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

DRUGConcurrent 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

View Full Details on ClinicalTrials.gov

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NCT07328841


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