Penpulimab Combined With Chemotherapy for Patients With Locally Advanced Hypopharyngeal Carcinoma

Who cannot join

• 1.Prior systemic therapy for advanced (metastatic) or unresectable (locally advanced) hypopharyngeal carcinoma, except for permitted neoadjuvant/adjuvant therapy. Neoadjuvant/adjuvant therapy must have been completed at least 6 months before the diagnosis of advanced and/or unresectable disease. Subjects who received prior neoadjuvant/adjuvant therapy and had R2 pathology after tumor resection are excluded.
• 2.Active autoimmune disease requiring systemic therapy (i.e., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic therapy and are permitted.3.Major surgery prior to the initiation of study intervention with inadequate recovery from surgery and/or surgical complications.4.Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).5.Prior treatment with EGFR-targeted agents.6.Anti-tumor therapy for advanced tonsillar cancer, including investigational drugs, within 4 weeks before enrollment.7.Unresolved adverse events (AEs) from prior anti-cancer therapy (i.e., AEs > Grade 1 or baseline). Subjects with neuropathy ≤ Grade 2 may be eligible based on investigator assessment.8.Radiotherapy within 2 weeks before the start of investigational treatment. Subjects must have recovered from all radiotherapy-related toxicities, be free of corticosteroid use, and have no history of radiation pneumonitis. A 1-week washout period is permitted for palliative radiotherapy (≤2 weeks of radiotherapy) for non-central nervous system (CNS) disease (if deemed safe by the investigator). A 2-week washout period is required for longer radiotherapy courses (>2 weeks).9.Administration of live vaccines within 30 days before the first dose of study drug.Note: Live vaccines include, but are not limited to: measles, mumps, rubella, varicella/zoster (chickenpox), yellow fever, rabies, bacillus Calmette-Guérin (BCG), and typhoid vaccines. Seasonal influenza vaccines administered by injection are generally inactivated virus vaccines and are permitted; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not permitted.10.Current or prior participation in a study of an investigational drug, or use of an investigational device within 4 weeks before the first dose of study drug.Note: Subjects who have entered the follow-up phase of an investigational study are eligible to participate in this study if at least 4 weeks have passed since the last dose of the prior investigational drug.11.Diagnosis of immunodeficiency or receipt of long-term systemic corticosteroid therapy (dose exceeding 10 mg prednisone equivalent per day) or any form of immunosuppressive therapy within 7 days before the first dose of study drug.12.History of another invasive malignancy that is progressive or required active treatment within the past 3 years.Note: Subjects with a history of skin basal cell carcinoma, skin squamous cell carcinoma, or carcinoma in situ (e.g., ductal carcinoma in situ of the breast, cervical carcinoma in situ) who have received potentially curative treatment are not excluded.13.Severe hypersensitivity reaction (> Grade 3) to toripalimab, nimotuzumab, albumin-bound paclitaxel, carboplatin, and/or any of their excipients.14.History of (non-infectious) pneumonitis requiring corticosteroid therapy, or current pneumonitis.15.Active infection requiring systemic therapy.16.Known history of human immunodeficiency virus (HIV) infection.17.Known active tuberculosis (TB; Mycobacterium tuberculosis).18.Severe, poorly controlled concurrent diseases (e.g., heart failure, diabetes mellitus, hypertension, liver failure, renal failure, thyroid disease, psychiatric illness, etc.).19.Major surgery within 30 days before the first dose of investigational drug or planned surgery during the study period.20.Inappropriate for study participation as assessed by the investigator.21.Unwillingness to participate in the study or inability to sign the informed consent form.22.Known history or any evidence of central nervous system (CNS) metastases and/or carcinomatous meningitis as assessed by the study site investigator.23.History or evidence of disease, treatment, or abnormal laboratory values that may interfere with trial results, prevent full participation in the study (e.g., hearing impairment), or that the investigator believes would not be in the subject's best interest to participate.24.Known psychiatric illness or substance abuse disorder that would interfere with the subject's ability to comply with study requirements.25.History of allogeneic tissue/solid organ transplantation.