About this trial
This is an Open Label, Non-Inferiority, Multicenter, Randomized Phase 3 Trial aimed to investigate the impact of reduced-dose radiotherapy in combination with chemotherapy and immunotherapy on patients' prognosis and complication compared with conventional-dose radiotherapy in combination with chemotherapy and immunotherapy for treatment-sensitive stage III NPC patients screened out according to the treatment response.
Eligibility criteria
Qualifiers
Age: 18 Years to 65 Years;
Eastern Cooperative Oncology Group performance status ≤1;
Patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma, the pathological type is non-keratinising carcinoma;
Tumor staged as Stage III (T3N0 Excepted; AJCC 8th);
Disqualifiers
Hepatitis B virus surface antigen (HBsAg) positive and Hepatitis B virus DNA > 1000 copies/ml;
Anti-hepatitis C virus positive;
Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS);
Active tuberculosis: active tuberculosis in the past 1 year should be excluded regardless with treatment, history of active tuberculosis over 1 year should be excluded except that previous regulatory anti-tuberculosis treatment is proved;
Trial design
Treatments tested in this trial
- PD-1 blocking antibody
- Gemcitabine
- Cisplatin (80 mg/m2)
- Reduced-dose Intensity-modulated radiotherapy
- Conventional-dose Intensity-modulated radiotherapy
- Cisplatin (100 mg/m2)
- Capecitabine
Treatment groups
Sponsors and collaborators
Sun Yat-sen University
Lead sponsor
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator