RecruitingPhase 3NCT07188584

Phase III Non-Inferiority Trial: Reduced-Target vs. Full-Target IMRT After Chemo in Immunotherapy-Treated Metastatic Nasopharyngeal Cancer

A Multicenter, Phase III Non-Inferiority Clinical Trial: Locoregional Volume-Reduction Versus Conventional Definitive Target IMRT Following Full-Dose Chemotherapy for Treatment-Naïve Distant Metastatic Nasopharyngeal Carcinoma Undergoing Full-Course Immunotherapy


Sponsor

Ming-Yuan Chen

Enrollment

166 participants

Start Date

Aug 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

In order to further verify the effectiveness of the new prevention irradiation model for low-risk areas for nasopharyngeal carcinoma under immunotherapy, our team intends to conduct a non-inferiority clinical trial. The aim is to evaluate the efficacy and safety of two treatment modalities - local region reduced-target radiotherapy versus full-target radiatiotherapy (with/without CTV2) for newly diagnosed distant metastasis nasopharyngeal carcinoma, based on the full-course immunotherapy and full-dose chemotherapy. The primary endpoints are 2-year PFS and the incidence of grade 3 or higher radiation-related adverse events. If non-inferiority is confirmed, a new standard of "immunotherapy combined with reduced-target radiotherapy" will be established, ensuring efficacy while significantly reducing toxicity, and providing a more optimal comprehensive treatment strategy for nasopharyngeal carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to radiation therapy for people with advanced nasopharyngeal cancer (cancer at the back of the nose) who responded well to chemotherapy combined with immunotherapy. It tests whether a smaller, more targeted radiation field works just as well as a larger one. **You may be eligible if...** - You are between 18 and 70 years old - You have metastatic (spread) nasopharyngeal cancer and have responded (fully or partially) to chemotherapy plus a PD-1 immunotherapy drug - You have not received more than one line of prior treatment - Your performance score is 0 or 1 (able to carry out normal daily activities) **You may NOT be eligible if...** - You have malignant fluid around the lungs or another cancer - You have a known or suspected autoimmune disease including epilepsy or dementia - You have significant heart problems - You received steroids or immune-suppressing medications within the past 4 weeks 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

RADIATIONReduced-Target Radiotherapy

Experimental group: GTVnx: 69.96 Gy/33 Fr/2.12 Gy; GTVnd: 69.96 Gy/33 Fr/2.12 Gy; CTV1: 60.60 Gy/33 Fr/1.82 Gy; GTV2: No prescription dose (only delineated, actual dose is scattered dose).

RADIATIONConventional Full-Target Radiotherapy

Control group: GTVnx: 69.96 Gy/33 F/2.12 Gy; GTVnd: 69.96 Gy/33 F/2.12 Gy; CTV1: 59.4 Gy/33 F/1.8 Gy; CTV2: 54 Gy/33 F/1.64 Gy.


Locations(1)

The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong 519000 Recruiting

Zhuhai, China

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NCT07188584


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