Clinical trial · Interventional
Adaptive Immunotherapy for Nasopharyngeal Carcinoma
Adaptive Immunotherapy for Locoregional Nasopharyngeal Carcinoma: a Randomized, Controlled, Multicenter, Phase 3 Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Cancinoma (NPC) | Nasopharyngeal Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Concurrent chemoradiotherapy (cCRT) | Drug | — | UNRESOLVED |
| Radical radiotherapy of nasopharynx and neck | Radiation | — | UNRESOLVED |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Low risk arm 1
- description
- Radiotherapy alone
- interventionNames
- Radiation: Radical radiotherapy of nasopharynx and neck
- Drug: Toripalimab
- type
- ACTIVE_COMPARATOR
- label
- Low risk arm 2
- description
- Concurrent chemoradiotherapy
- interventionNames
- Radiation: Radical radiotherapy of nasopharynx and neck
- Drug: Concurrent chemoradiotherapy (cCRT)
- Drug: Toripalimab
- type
- EXPERIMENTAL
- label
- High risk arm 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available