Short-course Tislelizumab Combined With Chemoradiotherapy for Nasopharyngeal Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- tislelizumab
- tislelizumab
- Gemcitabine + cisplatin (GP)
- Cisplatin (100mg/m2)
- intensity-modulated radiotherapy
Treatment groups
418 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov