About this trial
1. To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy. 2. To evaluate whether adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy improves event-free survival compared to adjuvant immunotherapy in high-risk locoregionally advanced nasopharyngeal carcinoma patients with stable disease or detectable serum EBV-DNA after induction chemoimmunotherapy.
Eligibility criteria
Qualifiers
18-65 years;
Newly diagnosed, pathologically confirmed non-keratinizing carcinoma (according to WHO criteria);
Locoregionally advanced nasopharyngeal carcinoma (Stage II-III) as defined by the 9th edition of the American Joint Committee on Cancer (AJCC) staging system;
ECOG performance status: 0-1;
Disqualifiers
T3N0-1, according to the American Joint Committee on Cancer (AJCC) Staging System, 9th Edition;
Disease progression after induction therapy;
Hepatitis B surface antigen (HBsAg) positive with HBV DNA >1×10³ copies/mL, or anti-hepatitis C virus (HCV) antibody positive;
Anti-HIV antibody positive or diagnosed with acquired immunodeficiency syndrome (AIDS);
Trial design
Treatments tested in this trial
- Radical radiotherapy of nasopharynx and neck
- Capecitabine
- Concurrent chemoradiotherapy (cCRT)
- Toripalimab