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.
Age: 18 years - 70 years.
The patient has signed the informed consent form and is willing and able to follow the visit schedule, treatment plan, laboratory tests and other research procedures as per the research plan.
Newly diagnosed distant metastasis patients who achieved complete response (CR) or partial response (PR) after receiving adequate first-line systematic therapy (platinum-containing doublet chemotherapy + PD-1 monoclonal antibody).
Nasopharyngeal carcinoma non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III), confirmed by histological and/or cytological examination, with metastatic lesions detected on imaging (biopsy of metastatic tissue is preferred but not mandatory).
Patients with malignant pleural effusion or those with other malignant tumors
Patients who have received ≥2 prior lines of systemic therapy.
Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.
Patients with grade ≥ II coronary heart disease, arrhythmia (including QTc interval prolongation in males > 450 ms, females > 470 ms) and heart failure.
Parallel
Reduced-Target Radiotherapy
RadiationExperimental 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).
Conventional Full-Target Radiotherapy
RadiationControl 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.
2-year Progression-Free Survival (PFS)
The PFS was defined as the duration from the date of random assignment to the date of disease progression or censored at the date of the last follow-up.
The incidence rate of radiotherapy-related ≥ grade 3 adverse events
Including the evaluation of acute subjective and objective toxic reactions as well as the evaluation of late subjective toxic reactions. The NCI-CTC 5.0 standard and RTOG standard were adopted.
Objective Response Rate(ORR)
Defined as the proportion of patients who, after receiving treatment, have achieved complete response (CR) or partial response (PR) and maintain this state for a certain period of time (evaluated by the investigator according to RECIST 1.1)
Disease control rate (DCR)
Defined as the proportion of patients who achieve CR + PR + SD after receiving treatment, and maintain this state for at least 4 weeks.
Overall survival time (OS)
Defined as the time interval from the start of randomization, due to any cause, death occurs (if no death, censored at the last known survival date).
Health-related Quality of Life
Changes from baseline in patient-reported quality of life scores assessed every 2 cycles using the EORTC QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, version C30). The scores range from 0 to 100, with higher scores indicating a better quality of life outcome.
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Ming-Yuan Chen
Lead sponsor
Sun Yat-sen University
Sponsor institution
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborator
Cancer Hospital of Guangxi Medical University
Collaborator
Fujian Cancer Hospital
Collaborator
The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborator
Zhejiang Cancer Hospital
Collaborator
West China Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Affiliated Cancer Hospital of Shantou University Medical College
Collaborator
Yunnan Cancer Hospital
Collaborator
First Affiliated Hospital of Kunming Medical University
Collaborator
Wuzhou Red Cross Hospital
Collaborator
Zhongshan People's Hospital, Guangdong, China
Collaborator
Southern Medical University, China
Collaborator
