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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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;
* Adequate bone marrow function: white blood cell count \> 4 × 10⁹/L, hemoglobin \> 90 g/L, platelet count \> 100 × 10⁹/L;
* Normal renal and hepatic function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL/min;
* Normal thyroid function, amylase, lipase, pituitary function;
* Completion of 3 cycles of GP regimen induction chemotherapy combined with PD-1 inhibitor immunotherapy;
* Patients must provide signed informed consent and be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;
* Female participants of childbearing potential must agree to use reliable contraceptive methods (e.g., condoms, regular use of oral contraceptives as prescribed) from screening until one year after treatment.
Exclusion Criteria:
* 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);
* Active tuberculosis;
* Active, known, or suspected autoimmune disease. Exceptions include type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia);
* History of interstitial lung disease or pneumonia requiring oral or intravenous steroid treatment within the past year;
* Chronic systemic glucocorticoid therapy or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are eligible;
* Uncontrolled cardiac disease;
* Pregnant or lactating women;
* History or current diagnosis of another malignancy, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma;
* Known allergy to macromolecular protein preparations or any component of toripalimab;
* Active infection requiring systemic treatment within one week prior to enrollment;
* Administration of a live vaccine within 30 days before the first dose of toripalimab;
* History of organ transplantation;
* Contraindications to MRI examination, which would prevent the completion of required imaging;
* Any other condition deemed by the investigators to potentially compromise patient safety or compliance.
Primary outcome measure(s)
Event-free survival — 3 year The primary endpoint was event-free survival from randomisation to disease recurrence (locoregional or distant) or death from any cause in the intention-to-treat population.
Incidence rates of vomiting as assessed by CTCAE v5.0 — 3 year In the low-risk arm, the primary outcome included the incidence rates of vomiting (evaluated according to the Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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