Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Test group:Camrelizumab + Chemotherapy
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Locally advanced head and neck squamous cell carcinoma confirmed by histology or cytology (i.e., UICC/AJCC TNM 8th edition staging system, stage III-IV without distant metastases); 2. A measurable, evaluable lesion that meets RECIST 1.1 criteria; 3. The tumour lesion is resectable or potentially resectable; 4. No previous immunotherapy; 5. Age: 18 to 75 years, male or female; 6. ECOG PS score: 0-1; 7. Function of vital organs in accordance with the following requirements (excluding the use of any blood components and cell growth factors during the screening period): a) Absolute neutrophil count = 1.5 x 109/L; Platelets = 80 x 109/L; Haemoglobin = 8.5g/dL; b) Thyroid-stimulating hormone (TSH) =1x ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be enrolled); c) Bilirubin =1.5 times ULN; ALT and AST =5 times ULN; d) Serum creatinine =1.5 times ULN. 8.Subjects of childbearing potential will be required to agree to use a medically approved contraceptive method for contraception during the study and for 6 months after the end of the study treatment period. 9. Subjects voluntarily enter the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women, or those of childbearing potential who refuse to use contraception; 2. Patients with two consecutive urinary proteins of 2+-3+, or proteinuria of 4+, who request additional testing for 24-hour urine protein quantification, which is >1g. 3. History of other malignancies in the last 5 years; 4. Allergy to any of the subject drugs and their excipients, history of severe allergies or contraindications to the subject drugs; 5. Uncontrolled, symptomatic brain metastases or a history of psychosis that cannot be easily controlled or severe intellectual or cognitive dysfunction; 6. Pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis and severely impaired lung function; 7. Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, and skin disorders that do not require systemic therapy (e.g., vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment; 8. Congestive heart failure, difficult-to-control arrhythmias, myocardial infarction, unstable angina pectoris, stroke, or transient ischaemic attack within 6 months; 9. Serious active infection requiring intravenous antibiotic therapy during the enrolment period; 10. live vaccination or imminent vaccination within 30 days prior to carilizumab administration; 11. Known history of HIV infection; 12. Unable to comply with the trial protocol or unable to cooperate with follow-up visits; 13. Persons who in the opinion of the investigator are not suitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate ;overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological complete response rate;objective response rate;disease control rate;event free survival; | — |
Countries
China
Contacts
Public ContactSusheng Miao
Harbin Medical University Cancer Hospital
Outcome results
None listed