Head and neck carcinomas
Conditions
Interventions
study group:Nimotuzumab injection: 400 mg on day 1, every 3 weeks (Q3W), for 2 cycles.
TPNab-paclitaxel: 260 mg/m^2 on day 1, Q3W
for 2 cycles.
Cisplatin or nedaplatin: 80 mg/m^2 on day 1, Q3W
Toripalimab: 240 mg on day 1, Q3W, for 2 cycles.
Dosing should be full dose in principle
a +/-10% variance is permitted based on clinical condition.
Sponsors
The Second People's Hospital of Shandong Province
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Age 18–75 years. 2. Histologically or cytologically confirmed Stage I–II squamous cell carcinoma of the larynx or hypopharynx. 3. urgically resectable but with anticipated impairment of organ function preservation. 4. ECOG performance status 0–1. 5. Availability of tumor tissue (from core biopsy or resected specimen) for PD-L1 testing; prior testing is acceptable. 6. At least one measurable lesion per RECIST version 1.1. 7. Expected overall survival >= 6 months. 8. Adequate hematologic function: White blood cell count >= 4 × 10?/L; Absolute neutrophil count >= 1.5 × 10?/L; Platelet count >= 100 × 10?/L; Hemoglobin >= 90 g/L. 9.Adequate renal function: Serum creatinine <= 1.5 × ULN, or creatinine clearance (CrCl) = 60 mL/min calculated by the Cockcroft-Gault formula: Female: CrCl = (140 - age) × body weight (kg) × 0.85 / (72 × Scr mg/dL) Male: CrCl = (140 - age) × body weight (kg) × 1.00 / (72 × Scr mg/dL) 10. Adequate hepatic function: Total bilirubin <= 1.5 × ULN; Aspartate aminotransferase (AST) <= 2.5 × ULN; Alanine aminotransferase (ALT) <= 2.5 × ULN. 11. Female subjects: Negative pregnancy test within 2 weeks before study treatment initiation and Non-lactating;Agree to use effective contraception during the study and for 6 months after the last dose of study drug. Male subjects:Agree to use effective contraception during the study and for 6 months after the last dose of study drug. 12. Subjects voluntarily participate in the study, provide written informed consent, and are able to comply with protocol-specified visits and procedures.
Exclusion criteria
Exclusion criteria: 1. Received anti–PD-1 inhibitors, anti-EGFR monoclonal antibodies, EGFR-TKIs, or anti-angiogenic agents within 4 weeks prior to enrollment. 2. Participated in another interventional clinical trial within 30 days prior to screening. 3. History of other malignancy (except cured basal cell carcinoma of the skin). 4. History of primary immunodeficiency. 5. Uncontrolled concurrent medical conditions (e.g., heart failure, severe pulmonary disease, severe hepatic disease, psychiatric disorders). 6. Known HIV infection, active viral hepatitis, or active tuberculosis. 7. Underwent major surgery within 90 days before the first dose of study drug, or planned major surgery. 8. Hypersensitivity to any study drug or its components. 9. Pregnant (confirmed by serum or urine HCG) or lactating women; subjects of reproductive potential unwilling or unable to use effective contraception (male and female) for at least 6 months after the last dose of study treatment. 10. Subjects considered ineligible by the investigator. 11. Subjects unwilling to participate or unable to provide written informed consent. 12. Administration of live vaccines within 30 days prior to dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (pCR) rate of the primary tumor;Major Pathological Response (MPR) rate;Organ function preservation rate;2-year Overall Survival (OS) rate;2-year Event-Free Survival (EFS) rate;2-year Locoregional Recurrence-Free Survival (LRFS) rate;2-year Distant Metastasis-Free Survival (DMFS) rate;Quality of Life (QoL); Safety assessment; | — |
Countries
China
Contacts
Public ContactYumei Wei
Department of Radiotherapy,the Second People's Hospital of Shandong Province
Outcome results
None listed