Hypopharyngeal squamous cell carcinoma
Conditions
Interventions
Experimental Group:Finotonlimab+TP regimen
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary Participation and Informed Consent: The patient voluntarily agrees to participate in this study and has signed the written informed consent form. 2.Age: Patients aged between 18 and 70 years (inclusive). 3.Diagnosis and Stage: Histologically confirmed squamous cell carcinoma of the hypopharynx. Clinical stage must be resectable locally advanced disease, defined as Stage III–IVb according to the AJCC Cancer Staging Manual, 8th Edition. 4.Performance Status:Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5.Prior Treatment: No prior history of systemic anti-tumor therapy (including chemotherapy, targeted therapy, or immunotherapy). 6.Measurable Disease: At least one measurable lesion as defined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, version 1.1). 7.Organ Function: Adequate organ function, defined by the following laboratory values obtained within 1 week prior to enrollment: 7.1 Hemoglobin:>=100 g/L 7.2 Leukocytes (WBC): >=4.0 × 10?/L OR Absolute Neutrophil Count (ANC): >=2.0 × 10?/L 7.3 Platelets: >=100 × 10?/L 7.4 Total Bilirubin: = 60 mL/min (calculated using the Cockcroft-Gault formula) 7.8 Blood Urea Nitrogen (BUN): = 1+, then 24-hour urine total protein must be =2.0 L. 7.12 Cardiac Function: No history of myocardial infarction within the past 1 year. No unstable angina. No symptomatic severe arrhythmia. No evidence of heart failure (e.g., NYHA Class III-IV).
Exclusion criteria
Exclusion criteria: 1.Histology: Pathologically confirmed non-squamous cell carcinoma. 2.Prior Malignancy and Metastasis: History of other malignant tumors. Evidence of distant metastasis or a second primary tumor indicated by PET-CT. 3.Prior Anti-tumor Therapy: Prior receipt of any systemic anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy, or immunotherapy). Receipt of any investigational drug within 4 weeks prior to the first dose of the study drug. 4.Autoimmune and Immune Status: Any active autoimmune disease or history of autoimmune disease requiring systemic treatment with corticosteroids (>10 mg prednisone equivalent per day) or other immunosuppressive agents. Known immunodeficiency disorders. History of solid organ transplantation. 5.Infectious Diseases: Currently in the acute phase of an infectious disease, Active infectious diseases including, but not limited to: 5.1 active pulmonary tuberculosis. 5.2 Chronic Hepatitis B with positive HBsAg and HBeAg (High viral replication status); 5.3 Human Immunodeficiency Virus (HIV) infection. 6.Pulmonary, Cardiac, and Systemic Comorbidities: 6.1 Interstitial Lung Disease (ILD): History of interstitial lung disease, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any clinically evident active ILD. 6.2 Pulmonary Fibrosis: Evidence of idiopathic pulmonary fibrosis on baseline CT scan. 6.3 Fluid Accumulation: Uncontrolled large pleural effusion or pericardial effusion. 6.4 Unstable Systemic Comorbidities, including: 6.4.1 Moderate to severe Chronic Obstructive Pulmonary Disease (COPD). 6.4.2 Uncontrolled hypertension. 6.4.3 Unstable angina, Congestive heart failure (CHF), Myocardial infarction occurring within the past 6 months. 6.4.4 Severe psychiatric disorders requiring medication control. 6.4.5 Severe hepatic, renal, or other metabolic diseases. 6.4.6 Neuropsychiatric disorders (e.g., Alzheimer’s disease). 7.Recent Surgery or Trauma: Major surgery or severe trauma performed within 4 weeks prior to the first dose of the study drug. 8.Investigator’s Discretion: Any abnormality in physical examination or clinical laboratory findings that, in the opinion of the Investigator, may interfere with the evaluation of study results or increase the risk of treatment-related complications for the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Transoral Minimally Invasive Surgery and Laryngeal Function Preservation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival;Objective Response Rate;Pathological Response Rates;2-Year Overall Survival (OS) and Disease-Free Survival (DFS); | — |
Countries
China PR
Contacts
Public ContactLin Gongbiao
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed