RAIRI-Guided Adjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Summary

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.

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

• Fudan University

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• Sun Yat-Sen University Cancer Center

  collaborator OTHER

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• Xiangya Hospital of Central South University

  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, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2030-12-31

Completion

2030-12-31

Countries

• China

Study Locations