Real-World RAIRI-Guided Risk Stratification for Adjuvant Therapy Benefit After Chemoradiotherapy in NPC

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-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.

Conditions

• Nasopharyngeal Carcinoma (NPC)

Interventions

DRUG

PD-1 inhibitor

Administered intravenously every 3 weeks for up to 12 cycles as adjuvant therapy.

DRUG

Capecitabine

Metronomic capecitabine administered orally at a dose of 650 mg/m2 twice daily for one year as adjuvant therapy.

Sponsors & Collaborators

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• Sun Yat-Sen University Cancer Center

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Cancer Hospital of Guizhou Province

  collaborator OTHER

• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  lead OTHER

Principal Investigators

• Junlin Yi · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2031-12-31

Completion

2031-12-31

FDA Drug

Yes

Countries

• China

Study Locations