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

Locations

26
Fujian Cancer Hospital FuzhouFujian, China
The First Affiliated Hospital of Xiamen University XiamenFujian, China
Dongguan People's Hospital DongguanGuangdong, China
The First People's Hospital of Foshan528000, FoshanGuangdong, China

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Collaborator