A Single-Arm Study of Sintilimab and Disitamab Vedotin for Locally Advanced Eyelid Sebaceous Gland Carcinoma

Inclusion criteria

1.Age 18 to 85 years (inclusive), regardless of gender; 2.Pathologically confirmed sebaceous gland carcinoma of the eyelid meeting the following criteria: a) Locally advanced disease; b) Deemed resectable or potentially resectable based on ophthalmic evaluation; c) Willing to undergo surgical treatment; 3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 4. Adequate organ and bone marrow functions defined as follows: a) Hematology: Absolute neutrophil count (NEUT#) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 80 × 10^9/L; Hemoglobin ≥ 8 g/dL; b) Hepatic function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; c) Serum albumin ≥ 2.8 g/dL; d) Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (CCR) > 60 mL/min; e) Coagulation function: International Normalized Ratio (INR) ≤ 1.5; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 5. Volunteer to participate in the study, provide written informed consent, and be capable of complying with all protocol-specified visits and related procedures

Exclusion criteria

Participants meeting any of the following criteria will be excluded: 1) History of other malignancies, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, and gastrointestinal intramucosal carcinoma with no recurrence within 5 years, or other malignancies deemed eligible by the investigator; 2) Any active autoimmune disease or history of autoimmune disease; 3) History of allergic diseases, severe drug allergies, or any component of the prescription (Note: severe allergy refers to those resulting in hospitalization); 4) Received any of the following treatments: a) Prior treatment with anti-PD-1, anti-PD-L1, or anti-HER2 therapies; b) Prior vaccination with anti-tumor vaccines; c) Use of any live vaccines against infectious diseases (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to the first dose or planned during the study period; d) Major surgery or severe trauma within 4 weeks prior to the first dose; 5) Concomitant severe medical conditions; 6) Known history of interstitial lung disease (ILD), non-infectious pneumonitis, or high suspicion of ILD, or subjects who may interfere with the detection or management of suspected drug-related pulmonary toxicity (subjects with a history of drug-induced or radiation-induced asymptomatic non-infectious pneumonitis are allowed to be enrolled), active tuberculosis, or a history of tuberculosis infection that remains uncontrolled after treatment; 7) Patients with hyperthyroidism and patients with organic thyroid diseases cannot be enrolled, patients with hypothyroidism on a stable dose of thyroid hormone replacement therapy can be enrolled, and patients with hypothyroidism controlled by thyroid hormone replacement therapy can be enrolled (whether it is controlled shall be confirmed by the investigator and/or the endocrinology department); 8) Active infection, or unexplained fever occurring during screening or within 48 hours prior to the first dose, or use of systemic antibiotics within 1 week prior to signing the informed consent form; 9) Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or hepatitis C (HCV antibody positive and HCV RNA above the lower limit of detection of the assay), or a known history of positive human immunodeficiency virus (HIV) test, or known acquired immunodeficiency syndrome (AIDS); 10) Clear prior history of neurological or psychiatric disorders, such as epilepsy or dementia; 11) Clear history of drug abuse or history of alcohol abuse within 3 months; 12) Pregnant or lactating women, subjects (and their partners) who have reproductive plans, engage in unprotected sexual intercourse, or are unwilling to adopt appropriate contraceptive methods (such as condoms, intrauterine devices, or partner ligation) from the screening period up to 3 months after the end of the study; 13) Received any investigational drug within 4 weeks prior to the first use of the study drug, or concurrently enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or follow-up phase of an interventional clinical study; 14) Other factors deemed by the investigator that may affect the study, leading to the inability to complete study treatment and follow-up