Resectable locally advanced squamous cell carcinoma of the head and neck
Conditions
Interventions
Experimental Group:Finotonlimab in combination with carboplatin and nab-paclitaxel
Sponsors
SUN YAT-SEN MEMORIAL HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age between 18 and 65 years old; 2) Cytological or histological diagnosis of surgically resectable head and neck squamous cell carcinoma, staged as follows: clinical stage III/IVA (cT1-2/cN1-2/M0 or cT3-4a/cN0-2/M0); 3) According to the RECIST 1.1 criteria for solid tumor efficacy evaluation, at least one measurable lesion on imaging; patients who have not received any prior treatment are eligible for this study; 4) ECOG score 0-1; 5) Expected survival time >3 months; 6) Sufficient organ function, with the following laboratory criteria: (1) Absolute neutrophil count (ANC) >= 1.5x10^9/L without the use of granulocyte colony-stimulating factor within the past 14 days; (2) Platelet count >= 100×10^9/L without blood transfusion in the past 14 days; (3) Hemoglobin >= 90 g/L without blood transfusion or use of erythropoiesis-stimulating agents in the past 14 days; (4) Total bilirubin = 60 ml/min; 7) Good coagulation function, defined as INR or PT <= 1.5×ULN; 8) Normal thyroid function, defined as TSH within the normal range. Subjects with baseline TSH outside the normal range may also be enrolled if total T3 (or FT3) and FT4 are within the normal range; 9) Normal myocardial enzyme spectrum (subjects with minor isolated laboratory abnormalities deemed clinically insignificant by the investigator are also allowed); 10) For women of childbearing potential, a urine or serum pregnancy test must be performed within 3 days prior to the first administration of the study drug (Cycle 1, Day 1) and be negative. If the urine pregnancy test cannot confirm a negative result, a blood pregnancy test is required. Women not of childbearing potential are defined as postmenopausal for at least 1 year, or surgically sterile or having had a hysterectomy; 11) If there is a risk of pregnancy, all subjects (male and female) must use contraception with a failure rate of less than 1% throughout the treatment period and until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy).
Exclusion criteria
Exclusion criteria: 1.Within 5 years prior to the first administration, diagnosed with any other malignant disease other than head and neck squamous cell carcinoma (excluding skin basal cell carcinoma that has undergone radical treatment, skin squamous cell carcinoma, and/or carcinoma in situ that has undergone radical resection); 2.Currently participating in an intervention clinical study for treatment, or having received other study drugs or used study equipment within 4 weeks prior to the first administration; 3.Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs targeting another type of stimulatory or synergistic inhibitory T-cell receptor (for example, CTLA-4, OX-40, CD137); 4.Within 2 weeks prior to the first administration, the subject had received systemic and systemic treatment with traditional Chinese medicine or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, excluding those used locally to control pleural effusion) for the treatment of head and neck squamous cell carcinoma. 5.Within 2 years prior to the first administration, there has been an occurrence of active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants). Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered as systemic treatment. 6.The study excluded subjects who were receiving systemic glucocorticoid therapy (excluding nasal, inhalational or other local glucocorticoid routes) or any other form of immunosuppressive therapy within 7 days prior to the first administration; Note: Administration of physiological doses of glucocorticoids (<= 10 mg/day of prednisone or equivalent drugs) is permitted; 7.There are cases of uncontrollable pleural effusion or peritoneal effusion in clinical practice (patients who do not require fluid drainage or who have no significant increase in fluid volume after 3 days of stopped drainage can be included in the study). 8.Known cases of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9.Known allergies to the active ingredients or excipients of the study drugs phenolizumab, carboplatin, or albumin-bound paclitaxel. 10.Before starting the treatment, there was no sufficient recovery from the toxicities and/or complications caused by any intervention (i.e., <= grade 1 or reaching the baseline, excluding fatigue or hair loss); 11.It is known that there is a history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies). 12.Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected to be greater than the upper limit of normal value in the laboratory of the research center where the test was conducted); Note: Hepatitis B subjects meeting the following criteria can also be enrolled: 1) Before the first administration, the HBV viral load was < 1000 copies/ml (200 IU/ml), and the subject should receive anti-HBV treatment throughout the study treatment period to avoid viral reactivation. 2) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and negative HBV viral load, no preventive anti-HBV treatment is required, but close monitoring of viral reactivation is necessary. 13.Active HCV-infected subjects (HCV antibody positive and HCV-RNA level above the detection limit); 14.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response rate, MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response Rate, PCR; | — |
Countries
China
Contacts
Public ContactLi Jinsong
SUN YAT-SEN MEMORIAL HOSPITAL
Outcome results
None listed