recurrent and metastatic head and neck squamous cell carcinoma
Conditions
Interventions
High EQD Group:radiotherapy with a high dose
Low EQD Group:radiotherapy with a lower dose
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed recurrent or metastatic head and neck squamous cell carcinoma, or WHO I-III nasopharyngeal carcinoma.; 2)Patients who are not suitable for or refuse surgery but are suitable for high-dose radiotherapy (suitable for high-dose radiotherapy is defined as having measurable lesions and no radical radiotherapy for measurable lesions within 2 years); 3)Have never been receiving immunocheckpoint inhibitors treatment; 4) Aged 18 years or older; 5) Had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 6) Adequate bone marrow function, including: absolute neutrophil count (ANC) 1,500/uL or 1.5x10^9/L; Platelets 75,000/uL or 75x10^9/L; Hemoglobin 9g/dL; 7) Adequate renal function: Creatinine 6 months; 11) Willing and able to follow the visit schedule, laboratory tests and other research procedures.
Exclusion criteria
Exclusion criteria: 1) Major surgery =180 degree; 4) Active autoimmune diseases that may worsen with the use of an immunostimulant; 5) Severe underlying diseases occurred during the 6 months before randomization, including: severe myocardial infarction/unstable angina pectoris, coronary artery/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism with existing symptoms; 6) Active infections requiring systemic treatment; 7) Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection during screening; 8) Previous organ transplants, including allogeneic stem cell transplants; 9) Female patients during pregnancy and lactation, male and female patients who are fertile but are not willing to use contraception throughout the study period; 10) Mentally ill patients (including those who have attempted suicide in the past year); 11) Staff of the research center directly involved in the implementation of the research and their families; 12) Patients participate in clinical drug studies involving other interventions within 4 weeks prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;overall survival;progression free survival; | — |
Countries
China
Contacts
Public ContactYao Yuan
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed