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Brief Title: Camrelizumab in Combination With Cetuximab and Chemotherapy for Relapsed/Metastatic HNSCC Patients
Official Title: A Phase II Study of Camrelizumab in Combination With Cetuximab and Chemotherapy as First-line Therapy for Patients With Relapsed/Metastatic Squamous Cell Carcinoma of Head and Neck
Study ID: NCT05673577
Brief Summary: This is a single-center, single-arm, phase 2 study to evaluate the efficacy and safety of camrelizumab in combination with cetuximab and chemotherapy as first-line for patients with relapsed/metastastic head and neck squamous cell carcinoma
Detailed Description: Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) not amenable to curative-intent therapies have poor survival. At present, the standard treatment is cetuximab and chemotherapy plus PD-1 inhibitor Regimen. This study is a phase II, prospective, single arm,single-center study, which requires a total of 40 R/M HNSCC patients. Patients will receive no more than 6 cycles of albumin paclitaxel and cisplatin, repeated every 3 weeks. PD-1 inhibitor will be administered until progression every 3 weeks. Cetuximab will be administered 400 mg/m2 at first dose, following by 250 mg/m2 after first dose until progression, repeated every 3 weeks.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fudan University, Shanghai, , China
Name: Dongmei Ji, doctor
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR