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RECRUITING

NCT07590024

PHASE3

RAIRI-Guided Adjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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.

Official title: Individualized Adjuvant Therapy Decision-Making for Locoregionally Advanced Nasopharyngeal Carcinoma Guided by Response-Adapted Individualized Risk Index (RAIRI): A Multicenter, Randomized, Controlled Phase III Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

651

Start Date

2026-05-01

Completion Date

2030-12-31

Last Updated

2026-05-28

Healthy Volunteers

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.

Inclusion Criteria 1. Age 18-65 years, regardless of sex. 2. Histologically confirmed EBER-positive, non-metastatic, non-keratinizing nasopharyngeal carcinoma. 3. 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. 4. Eastern Cooperative Oncology Group performance status score of 0-1. 5. Availability of complete baseline pretreatment imaging data, including nasopharyngeal and neck MRI with functional MRI sequences, and at least one measurable tumor lesion. 6. Availability of pretreatment baseline plasma cfEBV-DNA measurement. 7. Patients must meet the following laboratory criteria: hemoglobin \>120 g/L and white blood cell count ≥4 × 10⁹/L. 8. Platelet count ≥100 × 10⁹/L; liver and renal function parameters within 1.25 times the upper limit of normal; and no hearing impairment. 9. Ability to understand the study and provision of written informed consent. 10. Agreement to allow the use of personal data and biological samples, including blood and tissue samples, for research purposes. 11. Adequate function of major organs, except for abnormalities related to nasopharyngeal carcinoma. 12. Ability and willingness to comply with scheduled follow-up. Exclusion Criteria 1. Absence of pretreatment cfEBV-DNA data or other essential baseline characteristic data. 2. AJCC 8th edition stage I-II or IVB disease / AJCC 9th edition stage I or IV disease, or T3-4N0 or T3N1 disease. 3. History of other malignancies, except stage I non-melanoma skin cancer or carcinoma in situ of the cervix. 4. Pregnant or lactating women, or women of childbearing potential who are not using contraception. 5. Current participation in another investigational drug trial. 6. Severe comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, active ulcer disease, psychiatric illness, uncontrolled diabetes mellitus, active autoimmune disease, ongoing systemic immunosuppressive therapy, active infection requiring systemic treatment, history of human immunodeficiency virus infection, positive hepatitis B surface antigen, hepatitis B virus DNA \>1 × 10³ copies/mL or \>200 IU/mL, or positive hepatitis C virus antibody. 7. Inability to comply with regular follow-up.

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China