Head and neck squamous cell carcinoma
Conditions
Interventions
A:The patient received two cycles of toripalimab at 240 mg, paclitaxel albumin - bound at 260 mg/m2, combined with cisplatin at 75 mg/m2. One cycle was three weeks. After 4 - 6 weeks, imaging and surg
Sponsors
The First Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Untreated, histologically or cytologically confirmed locally advanced (stage III and IV) squamous cell carcinoma of the head and neck; 2. Patients who are judged by the surgeon to be operable or potentially operable; 3. Patients aged 18~70 years old; 4. ECOG: 0~1 min; 5. Expected survival time >= 6 months; 6. At least one measurable lesion according to RECIST 1.1 criteria; 7. Major organ function meets the following criteria (no blood components and cell growth factors are allowed within 14 days): a. Hemoglobin HB>=90 g/L; Neutrophil ANC>=1.5×10^9 /L; Platelet count PLT>=100×10^9 /L; b. Serum albumin >=28g/L; c. Total bilirubin TBIL=50 mL/min; e. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <=1.5× ULN (screenable for anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected therapeutic range of anticoagulants); f. Thyroid-stimulating hormone TSH<=6mIU/L; If the T3 and T4 levels are abnormal, the T3 and T4 levels are normal, and the T3 and T4 levels can be selected. 8. Women of childbearing age should agree to use contraceptive measures (such as intrauterine device, birth control pills or condoms) during and within 3 months after the end of the drug; Negative serum or urine pregnancy test within 7 days prior to study enrollment, and must be non-lactating patients, men should agree that contraception must be used during the study period and within 3 months after the end of the study period. 9. Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Subjects with a history of allergy to PD - 1 monoclonal antibody or any of the drugs such as paclitaxel (albumin - bound), cisplatin. 3. Subjects with a history of other malignancies within the past 5 years or concurrently, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, papillary thyroid carcinoma, etc. 4. Uncontrolled cardiac clinical symptoms or diseases, such as: (1) Heart failure of NYHA class II or above; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Subjects with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention. 5. Subjects who have received any of the following treatments: a. Any investigational drug before the first use of the study drug. b. Enrolled in another clinical study simultaneously, except for observational (non - interventional) clinical studies or follow - up of interventional new clinical studies. c. Subjects who required systemic treatment with corticosteroids (more than 10 mg prednisone equivalent per day) or other immunosuppressive agents within 2 weeks before the first use of the study drug, except for the use of corticosteroids for local inflammation, prevention of allergy, nausea, and vomiting. In the absence of active autoimmune diseases, inhalation or local use of steroids and replacement of adrenocortical hormones at a dose greater than 10 mg prednisone equivalent per day are allowed. d. Subjects who have received anti - tumor vaccines or live vaccines within 4 weeks before the first administration of the study drug. e. Subjects who have undergone major surgery or suffered serious trauma within 4 weeks before the first use of the study drug. 6. Subjects who have had a serious infection (CTC AE greater than grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging suggests active pulmonary inflammation; subjects with symptoms and signs of infection within 2 weeks before the first use of the study drug or those who require oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics). 7. Subjects with active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); subjects with autoimmune - mediated hypothyroidism treated with a stable dose of thyroid - replacement hormones; subjects with type 1 diabetes treated with a stable dose of insulin; but excluding vitiligo or childhood asthma/allergies that have been cured and do not require any intervention in adulthood. 8. Subjects with a history of immunodeficiency, including positive HIV test, or those with other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation or bone marrow transplantation. 9. Subjects with active tuberculosis infection detected by medical history or CT examination, or those with a history of active tuberculosis infection within 1 year before enrollment, or those with a history of active tuberculosis infection more than 1 year ago but without regular treatment. 10. Subjects with active hepatitis (HBV DNA = 2000 IU/ml or 10,000 copies/ml), hepatitis C (positive anti - HCV antibody and HCV - RNA above the lower limit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response,pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathologic response rate; | — |
Countries
China
Contacts
Public ContactJuntao Ran
The First Hospital of Lanzhou University
Outcome results
None listed