A Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection ± Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma

Exclusion Criteria

• •1. Tumors originating from nasopharyngeal, paranasal, nasal or salivary glands, thyroid or parathyroid lesions, skin, unknown primary squamous cell carcinoma or non-squamous histology (e.g., mucosal melanoma);
• •2. Peripheral neuropathy ≥ grade 2 (according to CTCAE v5.0);
• •3. Have received any of the following treatments:
• •* Received intravenous antibiotic therapy within 7 days prior to initial dosing;
• •* Investigational drugs that have received other clinical trials within 4 weeks prior to initial dosing;
• •* have received live attenuated vaccine within 4 weeks prior to first administration, and are allowed to receive inactivated seasonal influenza vaccine or approved COVID-19 vaccine without live virus;
• •* Received systemic immunostimulatory drugs (including but not limited to interferon, interleukin-2, etc.) within 4 weeks prior to initial administration;
• •* Had major surgery (e.g., transabdominal, thoracic, etc., excluding diagnostic puncture, infusion device implantation, or digestive home implantation) within 4 weeks prior to initial dosing, or expected to require major surgery during the study period; Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies (including ipilimumab) or any other antibody or drug that targets T-cell co-stimulation or immune checkpoint pathways;
• •4. A history of other primary malignancies within the past 3 years, excluding basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ that has been completely and radically resected;
• •5. Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke/myocardial infarction, unstable angina, congestive heart failure (NYHA Class II and above), or severe arrhythmia requiring medication within the first 6 months of enrollment;
• •6. Evidence of active infection includes hepatitis B (HBsAg positive with HBV DNA≥2000 IU/ml, excluding hepatitis due to drugs or other causes), hepatitis C (HCV positive with anti-HCV antibody), hepatitis B (HCV positive with HBV DNA≥2000 IU/ mL), and hepatitis C (HCV positive with HBV DNA≥2000 IU/ mL). HCV RNA results greater than the lower limit of detection) or human immunodeficiency virus (HIV) infection; Uncontrolled active bacterial, other viral, fungal, rickettsial, or parasitic infections, unless treated and resolved prior to administration of the investigational drug;
• •7. Loss of more than 10% of body weight in the 4 weeks prior to the first dose (unless appropriate nutritional support measures are taken);
• •8. Active gastrointestinal bleeding, or bleeding requiring more than 2 red blood cell transfusions or 4 units of compressed red blood cell transfusions within the first 4 weeks;
• •9. Patients with a history of primary immunodeficiency or active autoimmune disease who were taking immunosuppressants or systemic hormone therapy (dose ≥10 mg/ day of prednisone or other equivalent hormone) and continued to use it within 2 weeks prior to enrollment; Attention: Patients with type I diabetes, stable hypothyroidism with hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis, vitiligo, or psoriasis that does not require systemic treatment may be enrolled with topical or inhaled corticosteroids, or short-term (≤7 days) corticosteroids for prevention or treatment of non-autoimmune diseases. And infrequent allergic diseases are excluded. ;
• •10. A history of grade 3 allergy to any component of MRG003, Ptrelizumab injection, and/or cisplatin injection;
• •11. Previous history of interstitial pneumonia, radiation pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.;
• •12. History of organ transplantation, including allogeneic peripheral stem cell or bone marrow transplantation. After careful evaluation, patients who received autologous hematopoietic stem cell transplantation (HSTC) ≥ 5 years ago and who have normal bone marrow function (independent of transfusion) may be considered for study participation;
• •13. Other conditions deemed unsuitable for participation in this clinical trial by the investigator, including but not limited to serious mental illness, central nervous disorder, substance abuse, etc.