RecruitingPhase 3NCT07154069

Adaptive Immunotherapy for Nasopharyngeal Carcinoma

Adaptive Immunotherapy for Locoregional Nasopharyngeal Carcinoma: a Randomized, Controlled, Multicenter, Phase 3 Clinical Trial

Sponsor

Sun Yat-sen University

Enrollment

802 participants

Start Date

Nov 13, 2025

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Cancinoma (NPC)

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria10

-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 Criteria17

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.