This prospective, multicenter, real-world observational study aims to evaluate whether a response-adapted individualized risk index, the RAIRI model, can identify patients with non-metastatic nasopharyngeal carcinoma who may or may not benefit from adjuvant therapy after standard chemoradiotherapy. Patients will receive standard treatment according to routine clinical practice. After completion of chemoradiotherapy and assessment at approximately 1 month after radiotherapy, longitudinal multimodal response data, including plasma cfEBV DNA dynamics and MRI-based tumor response, will be incorporated into the RAIRI model to estimate the predicted 5-year progression-free survival. Patients will be stratified into a RAIRI low-risk group, defined as predicted 5-year PFS ≥85%, and a RAIRI high-risk group, defined as predicted 5-year PFS \<85%.
Within each RAIRI risk stratum, outcomes will be compared between patients who receive adjuvant systemic therapy, mainly PD-1 inhibitor-based adjuvant immunotherapy, and those who undergo routine surveillance without adjuvant systemic therapy. The primary endpoint is 3-year failure-free survival. Secondary endpoints include overall survival, locoregional relapse-free survival, distant metastasis-free survival, complete response rate after chemoradiotherapy, distribution of RAIRI risk groups, adverse events, late toxicities, and longitudinal health-related quality of life.
Age 18 to 75 years, male or female.
Histologically or cytologically confirmed EBER-positive non-keratinizing nasopharyngeal carcinoma, including differentiated or undifferentiated subtype.
Non-metastatic nasopharyngeal carcinoma confirmed by multimodal staging, corresponding to stage I-III according to the AJCC 9th edition staging system, or stage I-IVA according to the AJCC 8th edition staging system.
Eastern Cooperative Oncology Group performance status of 0-1.
Absence of pretreatment plasma cfEBV DNA measurement, or missing key baseline clinical variables required for RAIRI model calculation, such as age, AJCC stage, lactate dehydrogenase level, or central liquefactive necrosis status.
Presence of distant metastatic disease, M1.
History of previous or concurrent malignancy, except for non-melanoma skin cancer or cervical carcinoma in situ that has been successfully treated and has remained disease-free for more than 5 years.
Pregnant or breastfeeding women, or participants of reproductive potential who are unwilling to use effective contraception during the study observation period.
Patients aged 18 to 75 years with histologically or cytologically confirmed EBER-positive, non-keratinizing, non-metastatic nasopharyngeal carcinoma who are scheduled to receive standard chemoradiotherapy with or without induction therapy in routine clinical practice. Eligible patients must have pretreatment contrast-enhanced MRI of the nasopharynx and neck, pretreatment quantitative plasma cfEBV DNA measurement, ECOG performance status of 0-1, adequate baseline organ function, and reliable follow-up conditions. After completion of chemoradiotherapy, patients may either receive adjuvant systemic therapy, mainly PD-1 inhibitor-based immunotherapy, or undergo routine surveillance according to treating physician judgment and patient preference.
Cohort
Prospective
PD-1 inhibitor
DrugAdministered intravenously every 3 weeks for up to 12 cycles as adjuvant therapy.
Capecitabine
DrugMetronomic capecitabine administered orally at a dose of 650 mg/m2 twice daily for one year as adjuvant therapy.
3-year Failure-Free Survival (FFS)
FFS is defined as the time from enrollment to locoregional recurrence, distant metastasis, or death from any cause.
3-year Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
3-year Locoregional Relapse-Free Survival (LRRFS)
LRRFS is defined as the time from enrollment to the first locoregional recurrence or death from any cause.
3-year Distant Metastasis-Free Survival (DMFS)
DMFS is defined as the time from enrollment to the first distant metastasis or death from any cause.
Complete Response (CR) Rate after Chemoradiotherapy
Proportion of patients achieving a complete response after the completion of concurrent chemoradiotherapy.
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Fujian Cancer Hospital
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Hunan Cancer Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
Cancer Hospital of Guizhou Province
Collaborator
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Collaborator
Xijing Hospital
Collaborator
