Head and Neck Squamous Cell Carcinoma (including cancer of the oral cavity, oropharynx, hypopharynx, larynx, etc.)
Conditions
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years, male or female; 2. Histologically or cytologically confirmed previously untreated resectable primary stage III or IVA/IVB (AJCC 8th edition) head and neck squamous cell carcinoma (oral cavity, oropharynx, larynx, and hypopharynx); 3. At least one measurable lesion according to RECIST 1.1; 4. ECOG performance status 0-1; 5. Organ function must meet the following requirements (within 14 days prior to the first dose of the study drug): Bone marrow: absolute neutrophil count (ANC) >=1.5 x 10^9/L, platelets (PLT) >=100 x 10^9/L, hemoglobin (HB) >=9 g/dL (no blood transfusion or blood component administration within 14 days before the trial); Liver: total serum bilirubin (TBIL) =60 ml/min, blood urea nitrogen 1, a 24-hour urine protein test should be performed, with a total amount 50% on echocardiography; 6. Female subjects of childbearing potential must have a negative serum pregnancy test before taking the study drug for the first time; 7. Male or female subjects of childbearing potential must use effective contraception throughout the study (such as oral contraceptives, intrauterine devices, abstinence, or barrier methods combined with spermicide) and continue to use contraception for 90 days after completing treatment; 8. Subjects voluntarily participate in the study, sign the informed consent form, and comply with and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Prior Malignancies: Known active invasive malignancy or unresectable cancer within the past 5 years, except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early-stage prostate cancer, and carcinoma in situ of the cervix. 2.Thyroid Dysfunction: Thyroid dysfunction that cannot be maintained within the normal range despite pharmacological treatment. 3.Hematopoietic Growth Factors: Receipt of hematopoietic growth factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Erythropoietin [EPO], etc.) within 1 week prior to the first dose of study drug. 4.Prior Immuno-Oncology Therapy: Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or any drug targeting T-cell co-stimulation or checkpoint pathways (e.g., OX40, CD137 agonists or inhibitors). 5.Autoimmune Disease: Active, known, or suspected autoimmune disease; Type 1 diabetes mellitus; hypothyroidism requiring hormone replacement therapy; or skin diseases requiring systemic treatment. 6.Immunosuppressive Medication: Current use of systemic corticosteroids at a dose $> 10$ mg/day of prednisone (or equivalent) or any other form of immunosuppressive therapy within 14 days prior to enrollment. 7.Viral Infections:Known active Hepatitis B (defined as HBsAg reactive AND HBV DNA >= 1 x 10^4 copies/mL); Hepatitis C; Human lmmunodeficiency Virus (HIV)infection. 8.Tuberculosis: Active tuberculosis infection as determined by chest X-ray/CT, sputum analysis, and clinical physical examination. 9.Cardiac Disease: Severe cardiac disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina pectoris, myocardial infarction, or refractory hypertension. 10.Pregnancy and Lactation: Pregnant or breastfeeding women. 11.Contraception Compliance: Male or female patients of childbearing potential who are unwilling or unable to use effective contraception. 12.Concurrent Trials: Participation in another clinical trial of a drug or therapy within 4 weeks prior to the first dose of study drug. 13.Vaccination: Receipt of live vaccines within 30 days prior to the planned start of study treatment. 14.Hypersensitivity: Known hypersensitivity to the active ingredients or excipients of Iparomlimab and Tuvonralimab injection, Cisplatin, or Paclitaxel. 15.Investigator Judgment: Any history of disease, treatment, or laboratory abnormality that, in the opinion of the investigator, might affect the study results, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate, DCR;Progression-Free Survival, PFS ;Duration of Response, DOR;Overall Survival, OS;Treatment-Emergent Adverse Events, TEAE; | — |
Countries
China
Contacts
Public ContactXie Ke
Sichuan Provincial People's Hospital
Outcome results
None listed