RAIRI Model-Guided Adjuvant Therapy in Nasopharyngeal Carcinoma

This study aims to evaluate a personalized approach for treating patients with locoregionally advanced nasopharyngeal carcinoma (NPC). Currently, many high-risk patients receive additional treatment (adjuvant therapy) after standard chemoradiotherapy to prevent the cancer from returning. However, some patients may not actually need this extra treatment and could safely avoid its side effects. This trial uses a novel risk prediction model called the Response-Adapted Individualized Risk Index (RAIRI). The RAIRI model evaluates how a patient's tumor and blood markers (such as Epstein-Barr Virus DNA) respond during and immediately after their initial chemoradiotherapy. In this study, patients will be randomly assigned to one of two groups: 1. Standard Treatment Group: All patients will receive standard adjuvant therapy (either a PD-1 inhibitor or capecitabine) after completing their initial chemoradiotherapy. 2. RAIRI-Guided Group (Experimental): Patients will be evaluated using the RAIRI model after initial chemoradiotherapy. Only those identified as "high-risk" by the model will receive adjuvant therapy. Those identified as "low-risk" will be exempted from adjuvant therapy and will undergo regular observation. The main goal of this study is to determine if using the RAIRI model to exempt low-risk patients from adjuvant therapy is as safe and effective as giving adjuvant therapy to everyone, measured by how long patients live without the disease returning or progressing.

NCT Number	NCT07590024
Lead Sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences Collaborators: Fudan University, Peking University Cancer Hospital & Institute, Hunan Cancer Hospital, Sun Yat-Sen University Cancer Center, Fujian Cancer Hospital, Xiangya Hospital of Central South University, Cancer Hospital of Guizhou Province, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Xijing Hospital
Conditions	Nasopharyngeal Carcinoma (NPC)
Enrollment	651 participants
Start Date	2026-05-01
Primary Completion	2030-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-04