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

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma Read More

Inclusion Criteria:

1. 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);
2. Clinical stage of III-IVb (AJCC 2018);
3. Surgically unresectable and/or refuse surgery or appropriate for non-surgical definitive therapy;
4. Measurable disease;
5. Eastern cooperative oncology group performance status (ECOG PS) score: 0-1;
6. Blood routine: white blood cells> 3,000/mm3, hemoglobin> 8g/L, platelets> 80,000/mm3；Liver 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;
7. Sign the informed consent.

Exclusion Criteria:

1. Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;
2. 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%;
3. 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;
4. 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;
5. Patients undergoing therapy with other investigational agents;
6. Women who are pregnant or breastfeeding;
7. Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.