RAIRI Model-Guided Adjuvant Therapy in Nasopharyngeal Carcinoma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

Qualifiers

Age 18-65 years, regardless of sex.

Histologically confirmed EBER-positive, non-metastatic, non-keratinizing nasopharyngeal carcinoma.

AJCC 9th edition stage II-III disease / AJCC 8th edition stage III-IVA disease, excluding T3-T4N0 and T3N1 disease; or baseline EBV DNA >4,000 copies/mL.

Eastern Cooperative Oncology Group performance status score of 0-1.

Disqualifiers

Absence of pretreatment cfEBV-DNA data or other essential baseline characteristic data.

AJCC 8th edition stage I-II or IVB disease / AJCC 9th edition stage I or IV disease, or T3-4N0 or T3N1 disease.

History of other malignancies, except stage I non-melanoma skin cancer or carcinoma in situ of the cervix.

Pregnant or lactating women, or women of childbearing potential who are not using contraception.

Trial design

Treatments tested in this trial

  • PD-1 inhibitor
  • Capecitabine

Treatment groups

651 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Fudan University

Collaborator

Peking University Cancer Hospital & Institute

Collaborator

Hunan Cancer Hospital

Collaborator

Sun Yat-Sen University Cancer Center

Collaborator

Fujian Cancer Hospital

Collaborator

Xiangya Hospital of Central South University

Collaborator

Cancer Hospital of Guizhou Province

Collaborator

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Collaborator

Xijing Hospital

Collaborator