NCT05673577

Camrelizumab in Combination With Cetuximab and Chemotherapy for Relapsed/Metastatic HNSCC Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2023-03-22
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2023-01-06
• Last updated: 2026-04-02

Locations

1 site across 1 country: China