NCT05965154

Calizumab Combined With Bevacizumab and Capecitabine in the Treatment of Head and Neck Squamous Cell Carcinoma

Carrilizumab Combined With Bevacizumab Plus Capecitabine in a Second-line Prospective, One-arm Exploratory Study of Relapsed Metastatic Squamous Cell Carcinoma of Head and Neck

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, one-arm exploratory second-line study of carrilizumab combined with bevacizumab plus capecitabine in relapsed metastatic squamous cell carcinoma of the head and neck.

Detailed description

This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include histologically or cytologically determined squamous cell carcinoma of the head and neck, which the investigators assessed as metastatic. After the patients signed informed consent and met the screening criteria, the second-line patients received carrilizumab combined with bevacizumab and capecitabine until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study for a maximum of two years. Radiographic evaluations were performed using RECIST v1.1, and baseline evaluations were conducted within 28 days prior to enrollment. Tumor imaging evaluation was performed every 6 weeks (±3 days) from the first administration of the drug in the study. After reaching CR, patients entered the maintenance treatment period of carrilizumab. After 48 weeks, tumor imaging evaluation was performed every 12 weeks (±7 days). Imaging tests before signing the ICF, if within 28 days before starting treatment, can be used as screening tests. During the study, participants will receive safety follow-up from the first dose of carrilizumab until 30 days after the last dose). Experimental drugs: carrilizumab, bevacizumab, capecitabine Administration regimen: 1. Carrilizumab: 200mg/ cycle, three weeks as a treatment cycle, the first day of each cycle, intravenous drip; 2. Bevacizumab: 7.5mg/kg, intravenous infusion on the first day of each cycle, every 3 weeks for 1 cycle (Q3W); 3. Capecitabine: 1250mg/m2, three weeks as a treatment cycle, oral twice a day (once in the morning and once in the evening; Stop the drug for 1 week after 2 weeks of treatment. Duration of test plan and inclusion time: 1. Program selection time: 22 months. 2. Duration of the planned study: 24 months.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Carrilizumab, bevacizumab,capecitabine	1. Carrilizumab: 200mg/ cycle, three weeks as a treatment cycle, the first day of each cycle, intravenous drip; 2. Bevacizumab: 7.5mg/kg, intravenous infusion on the first day of each cycle, every 3 weeks for 1 cycle (Q3W); 3. Capecitabine: 1250mg/m2, three weeks as a treatment cycle, oral twice a day (once in the morning and once in the evening; Stop the drug for 1 week after 2 weeks of treatment.

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-04-01
• Completion: 2025-06-01
• First posted: 2023-07-28
• Last updated: 2023-07-28