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

July 20, 2023 updated by: Second Affiliated Hospital of Guangzhou Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Proportion of subjects assessed with CR or PR based on RECIST v1.1 criteria as a percentage of all enrolled patients
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control 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.
Proportion of subjects assessed as CR, PR, or SD based on RECIST v1.1 criteria.
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.
Progression-free survival time
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.
The time between the patient's first treatment date and any recorded tumor progression or death from any cause.
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.
Overall survival time
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.
The time between the patient's date of first treatment and death from any cause.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Investigators

  • Study Chair: Jingqi Chen, MD, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 23, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-LCYJ-ZF-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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