Short-course Tislelizumab Combined With Chemoradiotherapy for Nasopharyngeal Carcinoma (NCT07373990) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Short-course Tislelizumab Combined With Chemoradiotherapy for Nasopharyngeal Carcinoma
418 participantsStarted 2026-01-15
Plain-language summary
This trial aim to explore whether short-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 3 cycles of 400 mg q6w in the consolidation phase) yields non-inferior event-free survival compared to long-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 5 cycles of 400 mg q6w in the consolidation phase) in patients with locoregionally advanced nasopharyngeal carcinoma.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age ≥18 and ≤65 years
✓. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
✓. Eastern Cooperative Oncology Group performance score of 0-1.
✓. Tumor staged as T4N1 and T1-4N2-3 disease (AJCC 9th edition).
✓. Adequate marrow function:
Exclusion criteria
✕. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \>1×10 copies/mL, positive for anti-hepatitis C virus (HCV) antibody, positive for anti-hepatitis C virus (HCV) antibody
✕. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).
✕. Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received con dirmed and regular anti-tuberculosis treatment.
✕. Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.
✕. History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.
✕. Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone \>10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed.
✕. Uncontrolled cardiac conditions, such as: Heart failure with New York Heart Association (NYHA) classi dication ≥ Class II; or Unstable angina; or History of myocardial infarction within the past year; or Supraventricular or ventricular arrhythmias requiring treatment or intervention
✕. Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life)