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

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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

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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

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	18-75 years
Treatment	Camrelizumab, Apatinib Mesylate
Clinical Study Identifier	NCT04440917
Sponsor	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Last Modified on	19 February 2024

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