Head and neck squamous cell carcinoma
Conditions
Interventions
Research group:Srulizumab combined with cisplatin and 5-fluorouracil neoadjuvant therapy for head and neck squamous cell carcinoma
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Untreated, pathologically confirmed locally advanced head and neck squamous cell carcinoma; 2. patients who have been assessed by the surgeon as operable or non-operable (considering the reduced quality of life of patients after laryngeal cancer resection, for patients with laryngeal cancer who agree to be undergoing surgical resection with neoadjuvant therapy first, surgical treatment can be avoided first); 3. Patients aged 18~80 years; 4. ECOG: 0~1 points; 5. presence of measurable lesions according to RECIST criteria; 6. Estimated survival >= 6 months; 7. Major organ function meets the following criteria (no blood components and cell growth are allowed within 14 days Factor): (1).Hemoglobin HBG>=90g/L; neutrophil ANC>=1.5×10^9/L; Platelet count PLT>=100×10^9/L;(2).serum albumin>=28g/L; (3). Total bilirubin TBIL = 50mL/min; (5). activated partial prothrombin time (APTT) and international normalized ratio (INR) <=1.5×ULN (for anticoagulant therapy such as low molecular weight heparin or warfarin, which is on a stable dose and the INR is within the intended therapeutic range of the anticoagulant, it can be screened); (6).Thyroid-stimulating hormone TSH<=ULN; T3 and T4 levels should be examined if abnormalities are abnormal, and T3 and T4 levels are normal for admission; (7). No history of interstitial pneumonia or previous severe interstitial pneumonia; (8).Females of childbearing potential should agree to use contraception (such as intrauterine devices, birth control pills, or condoms) during and for 3 months after the end of medication; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Males should agree that contraception must be practiced for the duration of the study and for 3 months after the end of the study period; (9).Subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Received HNSCC anti-cancer therapy before the start of this trial; 2. Pregnant or lactating women; 3.A prior history of allergy to any drug in Srulizumab, 5-fluorouracil or cisplatin; 4. A history of other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma; 5.uncontrolled cardiac clinical symptoms or diseases, such as: (1). NYHA class II or above heart failure; (2). Unstable heart strangulation; (3). Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 6. Received any of the following treatment: (1). received any investigational drug prior to initial use of the investigational drug; (2). Enrolling in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or follow-up of an intervention new clinical study; (3). Subjects requiring systemic treatment with corticosteroids (greater than 10mg prednisone equivalent per day) or other immunosuppressants within 2 weeks prior to initial use of the study drug, except for corticosteroids for local inflammation and prevention of allergy and nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical steroid and adrenal corticosteroid replacement at doses greater than 10mg daily prednisone therapeutic dose are permitted;(4). Received an anti-tumor vaccine or a live vaccine within 4 weeks prior to the first administration of the investigational drug; (5). Major surgery or severe injury within 4 weeks prior to the first use of the study drug; 7. Serious infections (CTCAE greater than grade 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization; Baseline chest imaging findings indicate active lung inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics); 8.Active autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); But does not include but does not include vitiligo or childhood asthma/allergies that have healed and do not require any intervention as adults; 9. Have a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and bone marrow transplantation; 10.Patients who were found to have active pulmonary tuberculosis infection through medical history or CT examination, or had a history of active pulmonary tuberculosis infection within 1 year before enrollment, or had a history of active pulmonary tuberculosis infection 1 year before but had not received formal treatment; 11. The subject had active hepatitis (HBV DNA>=2000IU/ml or 10,000 copies/ml), hepatitis C (HCV antibody positive and HCV-RNA above the lower detection limit of the assay); 12. Known history of psychotropic substance abuse, alcohol abuse and drug use; 13. Patients who do not understand the requirements of the trial, or may not comply with the requirements of the trial; 14. Those deemed unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall Survival;Pathologic complete response;major pathological response; | — |
Countries
China
Contacts
Public ContactYifen Wu
Dongguan People's Hospital
Outcome results
None listed