Camrelizumab Combined With Apatinib Mesylate for Head and Neck Squamous Cell Carcinoma

  • STATUS
    Recruiting
  • participants needed
    32
  • sponsor
    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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Updated on 19 February 2024
See if I qualify
cancer
white blood cell count
measurable disease
squamous cell carcinoma of head and neck
squamous cell carcinoma
carcinoma
kidney function tests
head and neck cancer
apatinib
definitive treatment
locally advanced head and neck squamous cell carcinoma
advanced head and neck squamous cell carcinoma
caries
cancer of the head

Summary

This is a prospective, open-labelled study to evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the induction treatment of patients with locally advanced head and neck squamous cell carcinoma who were judged surgically unresectable or appropriate for non-surgical definitive therapy. The objective response rate (ORR) and safety will be evaluated as the primary endpoints, the 2-year overall survival (OS) rate and progression free survival (PFS) rate will be the second endpoints.

Details
Condition Head and Neck Squamous Cell Carcinoma
Age 18years - 75years
Treatment Camrelizumab, Apatinib Mesylate
Clinical Study IdentifierNCT04440917
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed squamous cell or poorly differentiated or undifferentiated cancer of the head and neck (the primary sites include oral cavity, oropharynx, hypopharynx, larynx, nasal cavity and sinuses)
Clinical stage of III-IVb (AJCC 2018)
Surgically unresectable and/or refuse surgery or appropriate for non-surgical definitive therapy
Measurable disease
Eastern cooperative oncology group performance status (ECOG PS) score: 0-1
Blood routine: white blood cells> 3,000/mm3, hemoglobin> 8g/L, platelets> 80,000/mm3Liver function: Alanine Transaminase/Aspartate Transaminase <2.5 times the upper limit of normal, bilirubin <1.5 times the upper limit of normal; Renal function: serum creatinine <1.5 times the upper limit of normal
Sign the informed consent

Exclusion Criteria

Patients with poor-controlled arterial hypertension (systolic pressure 140 mmHg and/or diastolic pressure 90 mm Hg) despite standard medical management
Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male 450 ms, female 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%
Has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin
Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
Patients undergoing therapy with other investigational agents
Women who are pregnant or breastfeeding
Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study
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cancer
white blood cell count
measurable disease
squamous cell carcinoma of head and neck
squamous cell carcinoma
carcinoma
kidney function tests
head and neck cancer
apatinib
definitive treatment
locally advanced head and neck squamous cell carcinoma
advanced head and neck squamous cell carcinoma
caries
cancer of the head

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