Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:Iparomlimab and tuvonralimab combined with chemotherapy
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old (including boundary value), gender is not limited; 2. Patients with histologically or cytologically confirmed locally advanced (T3-4/N2-3, M0) surgically resectable squamous cell carcinoma of the head and neck (oral cavity, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, nasal cancer, sinus cancer); 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0~1 points; 4. Not treated with any immune checkpoint inhibitors; 5. Have adequate organ function prior to the first use of the investigational drug, as defined below: (1) White blood cell count >= 4×10^9/L; (2) Neutrophil count (ANC) >=1,500/mm^3 (1.5 × 10^9/L); (3) Platelet count (PLT) >= 100,000/mm^3 (100 × 10^9/L), which cannot be met by blood transfusion; (4) Hemoglobin (Hb) >= 9 g/dL (90 g/L); (5) Serum creatinine = 60 mL/min; (6) Total bilirubin (BIL) = 1 year; 8. Judged by the investigator to be suitable for immune checkpoint inhibitor therapy; 9. Female subjects of childbearing age must have a pregnancy test within 7 days before starting the study drug, and the result is negative, and willing to use an effective contraceptive measure (such as: intrauterine device, birth control pill or condom) during the study and within 6 months after the last administration of the study drug; For male subjects whose partners are females of childbearing age, they should be surgically sterile or agree to use an effective method of contraception during the study and for 6 months after the last study dose; Male patients must also agree not to donate sperm during the same time period; 10. Signed informed consent and willing and able to comply with planned visits, study treatment, laboratory tests, and other trial procedures.
Exclusion criteria
Exclusion criteria: 1.Distant Metastasis: Presence of distant metastases. 2.Other Malignancies: History of other malignancies (excluding head and neck squamous cell carcinoma) within 5 years prior to randomization. 3.Transplant History: Prior solid organ or allogeneic hematopoietic stem cell transplantation, or planned transplantation during the study period. 4.Traditional Chinese Medicine (TCM): Received TCM with antitumor indications within 14 days prior to randomization. 5.Concurrent Clinical Trials: Participation in other interventional clinical trials involving drugs/medical devices within 28 days prior to randomization. 6.Major Surgery/Trauma: Undergone major surgery (excluding biopsies/venous catheterization) or experienced significant trauma within 28 days prior to randomization. 7.Vaccination: Received live attenuated vaccines within 28 days prior to randomization or planned during the study. 8.Immunosuppressive Therapy: Systemic corticosteroids (>10 mg prednisone/day equivalent) or immunosuppressants (e.g., cyclophosphamide, methotrexate) within 14 days prior to randomization or anticipated during treatment. Exceptions: Physiologic-replacement doses (=10 mg prednisone/day) for adrenal insufficiency without active autoimmune disease. Topical/ocular/intra-articular/nasal/inhaled corticosteroids. Premedication for contrast allergy. 9.Autoimmune Disease: Active autoimmune disease requiring systemic treatment within 2 years prior to randomization. Exceptions: Hypothyroidism on stable hormone replacement. Type 1 diabetes on stable insulin. Vitiligo with dermal manifestations only. 10.Prior Immunotherapy: Previous systemic anti-PD-1, PD-L1, PD-L2, CTLA-4 antibodies, or other T-cell/checkpoint-targeting agents. 11.Hypersensitivity: Known allergy to study drug components or history of severe hypersensitivity to monoclonal antibodies. 12.Severe Infections: Systemic infection requiring hospitalization or IV antibiotics =2 weeks within 28 days prior to randomization. Active infection requiring IV antibiotics within 14 days prior to treatment initiation. Exception: Prophylactic antibiotic use (e.g., for UTI prevention). 13.Cardiovascular Disease: Clinically significant cardiac/cerebrovascular disorders. 14.Pulmonary Conditions: Known or suspected interstitial lung disease (ILD). Moderate-to-severe respiratory diseases confounding pulmonary toxicity assessment (e.g., idiopathic pulmonary fibrosis, organizing pneumonia/BOOP). 15.Other Exclusionary Factors (Investigator’s judgment): Conditions increasing study risk or confounding results (e.g., substance abuse, severe psychiatric/neurological disorders). Comorbidities severely compromising survival (<5 years life expectancy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response ;Major Pathological Response;Progression Free Survival;Adverse Event; | — |
Countries
China
Contacts
Public ContactQiao Qiao
The First Affiliated Hospital of China Medical University
Outcome results
None listed