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

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.

Conditions

• Nasopharyngeal Carcinoma (NPC)

Interventions

RADIATION

Reduced-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).

RADIATION

Conventional 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.

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Cancer Hospital of Guangxi Medical University

  collaborator OTHER

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University

  collaborator UNKNOWN

• Sun Yat-sen University Cancer Center, Sun Yat-sen University

  collaborator UNKNOWN

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Affiliated Cancer Hospital of Shantou University Medical College

  collaborator OTHER

• Yunnan Cancer Hospital

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Wuzhou Red Cross Hospital

  collaborator OTHER

• Zhongshan People's Hospital, Guangdong, China

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• Ming-Yuan Chen

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-20

Primary Completion

2030-12-01

Completion

2031-07-01

Countries

• China

Study Locations