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

Sponsor
Second Affiliated Hospital of Guangzhou Medical University
Study ID
NCT05965154
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Carrilizumab, bevacizumab,capecitabine — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jul 28, 2023
Start date
Aug 1, 2023
Status verified
Apr 2023
Primary completion
Apr 1, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Carrilizumab combined with bevacizumab plus capecitabine
    This study is a one-arm, exploratory study and does not involve randomization.There was only one trial group of carrilizumab plus bevacizumab plus capecitabine.

Primary Outcome Measure

Objective response rate [ Time Frame: From the time a patient signs the ICF to the last dose, each patient will be followed up until death or withdrawal from the study or until 6 months after the last eligible patient is enrolled. ]

Central Contacts

Related Studies