nasopharyngeal carcinoma
Conditions
Interventions
experiment group:Treatment stratification based on therapeutic response: High-risk RAIRI patients with poor treatment response receive adjuvant therapy with either capecitabine or PD-1 monotherapy, wh
control group :Adjuvant therapy with either capecitabine or PD-1 monotherapy is administered following CCRT +/- IC.
Sponsors
National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years, regardless of gender; 2. Histologically confirmed EBER-positive non-keratinizing nasopharyngeal carcinoma; 3. Stage III–IVA disease according to AJCC 8th edition, excluding T3–T4N0 and T3N1 stages; 4. ECOG performance status 0–1; 5. Availability of comprehensive baseline imaging data of the nasopharynx and neck before treatment, including MRI with functional sequences, and presence of measurable lesions; 6. Baseline cfEBV-DNA level measured prior to treatment; 7. The enrolled patient must also meet the following clinical laboratory criteria: hemoglobin >120 g/L, WBC >=4×10?/L; 8. Platelet count >=100×10?/L; hepatic and renal function parameters within 1.25 times the upper limit of normal, and no hearing impairment; 9. Able to understand the study and has signed informed consent; 10. Agrees to the use of personal data and biological samples (e.g., blood, tissue) for research purposes; 11. Normal function of major organs (excluding abnormalities related to nasopharyngeal carcinoma); 12. Eligible for follow-up.
Exclusion criteria
Exclusion criteria: 1. Absence of pretreatment cfEBV-DNA data or other required baseline characteristics; 2. AJCC 8th edition stage I–II, or T3–T4N0 or T3N1 disease; 3. History of other malignancies, except for stage I non-melanoma skin cancer or carcinoma in situ of the cervix; 4. Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception; 5. Currently participating in another drug trial; 6. Presence of severe comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, peptic ulcer, psychiatric disorder, uncontrolled diabetes, active autoimmune disease, ongoing systemic immunosuppressive therapy, active infections requiring systemic treatment, history of HIV infection, HBsAg positivity, HBV DNA >1×10³ copies/mL or >200 IU/mL, or HCV antibody positivity; 7. Inability to comply with regular follow-up requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year Failure-Free Survival, FFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 year Overall Survival, OS;3 year Local Regional Failure-Free Survival, LRFFS;3 year Distant Metastasis-Free Survival, DMFS;Complete response rate after chemoradiotherapy;Proportion of RAIRI high-risk and low-risk patients after chemoradiotherapy;Acute and late toxicities and adverse events;Quality of life and its changes; | — |
Countries
China
Contacts
Public ContactJunlin Yi
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed