Squamous Cell Carcinoma of Head and Neck
Conditions
Interventions
Test group:Camrelizumab + Apatinib mesylate + Chemotherapy
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 70 years old; 2) Potentially resectable head and neck squamous cell carcinoma, Stage III-IVB, including Oral Cavity, Oropharynx, Hypopharynx and Larynx, diagnosed by histological or cytological pathology in accordance with the 2020 CSCO Guidelines for the Management of Head and Neck Tumours; 3) At least one measurable lesion according to the RECIST version 1.1 evaluation criteria; 4) For patients with oropharyngeal cancer, HPV status confirmed by P16 immunohistochemistry prior to enrolment; 5) ECOG score of 0-1; 6) Laboratory and instrumentation tests that meet the following requirements: Blood routine: neutrophil count = 1,500/mm3 (1.5 × 109/L) (no growth factors within 14 days); platelet count = 100,000/mm3 (100 × 109/L) (no corrective therapy within 7 days); haemoglobin = 9.0 g/dL (90 g/L) (no corrective therapy within 7 days); Blood biochemistry: serum creatinine = 1.5 times the upper limit of normal (ULN) or creatinine clearance = 60 ml/min; total bilirubin = 1.5 × ULN; glutamic oxaloacetic transaminase and glutamic propyltransferase = 2.5 × ULN; 12-lead ECG: Fridericia-corrected QT interval (QTcF) < 470 msec; cardiac ultrasound: LVEF = 50%. 7) Patients will voluntarily participate in the study and sign an informed consent form, and are expected to be compliant and able to cooperate with the study according to the requirements of the protocol. 8) Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrolment and voluntarily use an appropriate method of contraception during the observation period and for 4 months after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1) Previously received any form of anti-tumour therapy (chemotherapy, radiotherapy, immunotherapy, molecular targeted therapy, etc.); 2) Those with a history of other malignant tumours (except cured basal cell carcinoma of the skin) 3) Presence of any active autoimmune disease or history of autoimmune disease with expected relapse (including, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects who can be controlled only by hormone replacement therapy may be included]; subjects with skin diseases that do not require systemic therapy such as vitiligo , psoriasis, alopecia areata, type I diabetes mellitus or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be included; asthmatics requiring medical intervention with bronchodilators may not be included); 4) Use of corticosteroids (>10 mg/day prednisone or equivalent dose) or other immunosuppressive agents within 14 days prior to the first study drug. Inhaled or topical steroids and adrenal replacement steroids are allowed in the absence of active autoimmune disease; 5) Patients with a known history or high suspicion of interstitial pneumonia; or patients who may interfere with the detection or management of suspected drug-related pulmonary toxicity; 6) Subjects with active tuberculosis (TB) or a history of active TB infection within =48 weeks prior to screening, with or without treatment; 7) Live attenuated vaccination within 28 days prior to the first dose of treatment or scheduled to occur during the study and within 60 days after completion of study drug treatment. 8) Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome, active Hepatitis B (HBV DNA = 1000 IU/ml), Hepatitis C (Hepatitis C antibody positive with HCV-RNA above the lower limit of detection of the analysing method), or co-infection with Hepatitis B and Hepatitis C; 9) Myocardial infarction, severe/unstable angina pectoris, NYHA class 2 or higher cardiac insufficiency, grade =2 sustained arrhythmia (according to NCI CTCAE version 5.0), atrial fibrillation of any grade, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebral vascular accidents including transient ischaemic attacks, or symptomatic pulmonary embolism in the 6 months prior to the date of enrolment; 10) Complicated severe infection (e.g., intravenous antibiotic, antifungal, or antiviral medication required according to clinical protocols) within 4 weeks prior to the first dose, or unexplained fever >38.5°C during the screening period/prior to the first dose; 11) Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding or thrombotic tendency or on thrombolytic or anticoagulant therapy; 12) Exclude patients with factors that significantly interfere with oral drug absorption (e.g., inability to swallow, chronic diarrhoea and intestinal obstruction); 13) Known history of allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation; 14) Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to use effective contraception; (15) Other conditions that, in the judgement of the investigator, may affect the conduct of the clinical study and the determination of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological response, MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;pathological complete remission rate, pCR;1-year local regional control rate, 1y-LRC;1-year overall survival rate, 1y-OS;1-year progression-free survival rate, 1y-PFS;Quality of life score;Safety;Impact of tumour-related markers on prognosis; | — |
Countries
China
Contacts
Public ContactZheng He
The First Hospital of China Medical University
Outcome results
None listed