recurrent or metastatic head and neck squamous cell carcinoma
Conditions
Interventions
Arm1:PD-1 antiboy+chemotherapy
Arm2:cetuximab+Chemotherapy
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged>=18 years; 2. Has histologically or cytologically-confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies; 3. Has at lease one measurable lesion; 4. Sign inform consent; 5. ECOG PS 0-1; 6. Has a life expectancy of more than 6 months.
Exclusion criteria
Exclusion criteria: 1. Previously treated with chemotherapy; 2. Previously treated with surgery or radiotherapy within 4 weeks; 3. Previously treated with anti-EGFR antibody, anti-PD-1/L1 antibody or anti-CTLA4 antibody; 4. NPC; 5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; 6. A medical or psychological condition that will prevent the subject from completing the trial or signing informed consent; 7. No legal capacity/limited capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactGuopei Zhu
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed