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
Overview
- Phase
- Phase 2
- Intervention
- Camrelizumab+cetuximab+chemotherapy
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Sponsor
- Fudan University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Ji Dongmei
Associate Professor
Fudan University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Camrelizumab+cetuximab+chemotherapy
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
Intervention: Camrelizumab+cetuximab+chemotherapy
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: 2 years after enrollment of final patient
Objective response rate measured as number of complete and partial response divided by the number of patients included.
Secondary Outcomes
- Overall Survival (OS)(up to 2 years)
- Adverse events(Since the signing of informed consent forms to 30 days after the last cycle)
- Progression-free Survival (PFS)(up to 2 years)