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Trial Title:
Calizumab Combined With Bevacizumab and Capecitabine in the Treatment of Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT05965154
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Bevacizumab
Capecitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Carrilizumab, bevacizumab,capecitabine
Description:
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.
Arm group label:
Carrilizumab combined with bevacizumab plus capecitabine
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically or cytologically determined, the investigators assessed patients with
relapsed or metastatic squamous cell carcinoma of the head and neck. Including
nasopharyngeal cancer, oral cancer, oropharyngeal cancer, hypopharyngeal cancer,
laryngeal cancer, etc.
- The age range is between 18 and 85.
- Expected survival > 6 months.
Exclusion Criteria:
- Patients with uncured malignancies other than recurrent or metastatic squamous cell
carcinoma of the head and neck diagnosed within 5 years prior to initial
administration (excluding radical cutaneous basal cell carcinoma, cutaneous squamous
epithelial carcinoma, and/or carcinoma in situ after radical excision).
- Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that
target another stimulus or synergistic inhibition of T cell receptors (e.g., CTLA-4,
OX-40, CD137).
- Known allogeneic organ transplantation (except corneal transplantation) or
allohematopoietic stem cell transplantation.
- other.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Start date:
August 1, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Second Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Source:
Second Affiliated Hospital of Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05965154
