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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Camrelizumab: 200mg vgtt q3w, 3 weeks as a cycle; Cetuximab first dose 400mg/m2, vgtt, following by 250 mg/m2 after first dose, qw, 3 weeks as a cycle; albumin paclitaxel: 125mg/m2, vgtt, d1, 8, q3w,for up to 6 cycles; cisplatin: 75mg/m2, vgtt,d1,q3w, for up to 6 cycles; Then, in maintenance therapy, Camrelizumab: 200mg vgtt q2w; Cetuximab 500mg/m2, vgtt q2w until intolerable toxicity or disease progression
Fudan University
Shanghai, China
Objective response rate (ORR)
Objective response rate measured as number of complete and partial response divided by the number of patients included.
Time frame: 2 years after enrollment of final patient
Adverse events
Hematologic and non hematologic adverse event (CTCAE 5.0)
Time frame: Since the signing of informed consent forms to 30 days after the last cycle
Progression-free Survival (PFS)
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: up to 2 years
Overall Survival (OS)
Overall Survival (OS) (median) was determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.
Time frame: up to 2 years
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