NCT07740993尚未招募2 期
A Single-Arm, Prospective Clinical Study of Sintilimab Combined With Disitamab Vedotin as Neoadjuvant Therapy for Locally Advanced Eyelid Sebaceous Gland Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Major Pathologic Response (MPR) Rate
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant therapy with Sintilimab combined with Disitamab Vedotin in patients with locally advanced, resectable or potentially resectable sebaceous gland carcinoma. The main questions it aims to answer are: What is the major pathological response (MPR) rate after the neoadjuvant therapy? What are the pathological complete response (pCR) rate, clinical objective response rate (ORR), disease control rate (DCR), safety profiles, and 1-year disease-free survival (DFS) of this regimen? Participants will:Receive neoadjuvant therapy consisting of Sintilimab (200 mg, IV, Day 1) and Disitamab Vedotin (2.5 mg/kg, IV, Day 1) every 3 weeks for a total of 2 cycles. Undergo radical surgery after the completion of the neoadjuvant treatment phase. Receive postoperative adjuvant therapy after surgery, which includes uniform Sintilimab monotherapy maintenance (200 mg, IV, Q3W) for up to 1 year, and may receive risk-stratified local interventions (such as local radiotherapy or repeat wide excision) depending on the pathological risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •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;
- •Volunteer to participate in the study, provide written informed consent, and be capable of complying with all protocol-specified visits and related procedures
排除标准
- •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
结局指标
主要结局
Major Pathologic Response (MPR) Rate
时间窗: At the time of surgery, after completion of neoadjuvant treatment
Among participants who undergo surgery, major pathologic response (MPR) is defined according to immune-related pathologic response criteria (irPRC) as ≤10% residual viable tumor cells in the tumor bed (%RVT ≤10%), regardless of whether residual viable tumor cells are present in lymph nodes.
次要结局
- Pathologic Complete Response (pCR) Rate(At the time of surgery, after completion of neoadjuvant treatment)
- Objective Response Rate (ORR)(From baseline to pre-operative tumor assessment following 2 cycles of neoadjuvant therapy (up to 9 weeks))
- Disease Control Rate (DCR)(From baseline to pre-operative tumor assessment following 2 cycles of neoadjuvant therapy (up to 9 weeks).)
- Adverse Events (AEs)(From first dose through 30 days after the last dose of neoadjuvant treatment)
- Surgery Delay Rate(From completion of Cycle 2 of neoadjuvant therapy (each cycle is 21 days) to the date of radical surgery.)
- 1-Year Disease-Free Survival (DFS) Rate(From the date of radical surgery up to 1 year.)
- R0 Resection Rate(At the time of surgery, after completion of neoadjuvant treatment)
研究者
Xingchen Peng
Professor
West China Hospital
研究点 (1)
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