Real-World RAIRI-Guided Risk Stratification for Adjuvant Therapy Benefit After Chemoradiot
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 receiv
| Condition(s) | Nasopharyngeal Carcinoma (NPC) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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-ri |
| Who can participate | Inclusion Criteria 1. Age 18 to 75 years, male or female. 2. Histologically or cytologically confirmed EBER-positive non-keratinizing nasopharyngeal carcinoma, including differentiated or undifferentiated subtype. 3. 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. 4. Eastern Cooperative Oncology Group performance status of 0-1. 5. Availability of complete pretreatment high-quality contrast-enhanced MRI of the nasopharynx and neck, including functional MRI sequences such as diffusion-weighted imaging, and at least one measurable tumor lesion according to RECIST version 1.1. 6. Availability of pretreatment quantitative plasma |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2026-01-01 |
| NCT ID | NCT07618078 |
| Official listing | https://clinicaltrials.gov/study/NCT07618078 |