T4a Stage Laryngeal Carcinoma
Conditions
Interventions
Single arm (T4aN1-3M0 stage laryngeal cancer patients):Induction chemoimmunotherapy (Fenolimab 200mg + Paclitaxel 260mg/m^2 + Cisplatin 75mg/m^2, every 3 weeks for 1 cycle, total 3 cycles)
if PR or CR is assessed, then radical chemoradiotherapy (IMRT, GTV 66-70Gy/28-33F, concurrent cisplatin 100mg/m^2 q3w)
followed by fenolimab maintenance therapy (200mg per dose, every 3 weeks for 1 cycle, total 8 cycles, maintained for 1 year). If SD or PD is assessed, proceed to total laryngectomy with neck lymph nod
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients must be informed of the basic contents of this study, voluntarily participate, and provide written informed consent; 2. Age between 18 and 70 years; 3. Pathologically confirmed squamous cell carcinoma of the larynx, staged as T4aN1–3M0 according to the 8th edition of the AJCC staging system; 4. Evaluated by an otolaryngology–head and neck surgeon as unsuitable for laryngeal preservation surgery; 5. No contraindications to radiotherapy or chemotherapy, and no prior antitumor treatment, including radiotherapy, chemotherapy, immunotherapy, targeted therapy, or surgery; 6. Performance status: Karnofsky Performance Scale (KPS) >= 80, Eastern Cooperative Oncology Group (ECOG) score 0–1, and expected survival >= 3 months; 7. Adequate bone marrow function: white blood cell count >= 4 × 10^9/L, hemoglobin >= 90 g/L, and platelet count >= 100 × 10^9/L; 8. Adequate liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 60 mL/min; 10. Adequate pulmonary function: forced expiratory volume in one second (FEV1) >= 60% of predicted value, with no history of pneumonia in the past three months.
Exclusion criteria
Exclusion criteria: 1. Known allergy or hypersensitivity to cisplatin, paclitaxel, or Finotonlimab; 2. Presence of other concurrent malignant tumors; 3. History of malignancy, with the exception of adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, papillary thyroid carcinoma, and carcinoma in situ of the cervix; 4. Pregnant or breastfeeding women (women of childbearing potential must undergo pregnancy testing; effective contraception must be ensured during the treatment period); 5. Prior treatments as follows: (1) Anti–PD-1, anti–PD-L1, or anti–CTLA-4 therapy; (2) Treatment with another investigational agent within 4 weeks prior to the first dose of study drug; (3) Systemic corticosteroid therapy (or other immunosuppressive therapy) within 2 weeks prior to the first dose of study drug. Inhaled or topical corticosteroids (= 500 IU/mL or 2,500 copies/mL) or active hepatitis C infection (anti-HCV positive with HCV RNA above the lower limit of detection); 11. History of substance abuse or alcohol abuse; 12. Prior treatment to the primary tumor site or cervical nodal metastases (except diagnostic procedures); 13. Presence of other severe comorbidities that, in the investigator’s judgment, may pose significant risk or interfere with study compliance (including but not limited to those diseases listed above).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year Overall Survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year Disease-Free Survival Rate;3-year Locoregional Failure-Free Survival Rate;3-year Laryngo-Esophageal Dysfunction-Free Survival Rate;Incidence Rate of Grade >=3 Acute Radiation (or Chemotherapy)-Related Toxicity During Induction Radiotherapy (Chemotherapy) and Within 90 Days After Completion;Incidence Rate of Grade >=3 Acute Immune-Related Toxicity During Immunotherapy and Within 90 Days After Treatment Completion (Including Induction and Maintenance Therapy);Incidence Rate of Grade >=3 Late Radiation-Related Toxicity Occurring More Than 90 Days After Completion of Radiotherapy;Incidence Rate of Grade III or Higher Postoperative Surgical Complications Within 30 Days After Total Laryngectomy;Treatment Adherence;Quality of Life;3-year Laryngo-Esophageal Dysfunction-Free Survival Rate;Objective Response Rate (ORR) at 2 Weeks After Completion of the Final Induction Chemo-Immunotherapy Cycle;3-year Progression-Free Survival After Treatment Completion; | — |
Countries
China
Contacts
Public ContactLei Wenbin
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed