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

Last updated: July 20, 2023
Sponsor: Second Affiliated Hospital of Guangzhou Medical University
Overall Status: Active - Not Recruiting

Phase

2

Condition

Head And Neck Cancer

Lung Cancer

Squamous Cell Carcinoma

Treatment

Carrilizumab, bevacizumab,capecitabine

Clinical Study ID

NCT05965154
2022-LCYJ-ZF-09
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically determined, the investigators assessed patients withrelapsed or metastatic squamous cell carcinoma of the head and neck. Includingnasopharyngeal cancer, oral cancer, oropharyngeal cancer, hypopharyngeal cancer,laryngeal cancer, etc.
  • The age range is between 18 and 85.
  • Expected survival > 6 months.

Exclusion

Exclusion Criteria:

  • Patients with uncured malignancies other than recurrent or metastatic squamous cellcarcinoma of the head and neck diagnosed within 5 years prior to initialadministration (excluding radical cutaneous basal cell carcinoma, cutaneous squamousepithelial 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 targetanother stimulus or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40,CD137).
  • Known allogeneic organ transplantation (except corneal transplantation) orallohematopoietic stem cell transplantation.
  • other.

Study Design

Total Participants: 22
Treatment Group(s): 1
Primary Treatment: Carrilizumab, bevacizumab,capecitabine
Phase: 2
Study Start date:
August 01, 2023
Estimated Completion Date:
June 01, 2025

Study 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.