Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University

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

593 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Collaborator