NCT07646145招募中2 期
Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Medium-high Risk Non-Muscle-Invasive Bladder Cancer: A Phase II Clinical Trial
Shanxi Province Cancer Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1-year disease-free survival rate(1-year DFS rate)
研究概览
简要总结
This study aims to evaluate the efficacy and safety of intravenous administration of vedacitinib combined with intravesical instillation of mitomycin in treating patients with high-risk NMIBC with HER2 expression. The goal is to provide a new treatment option for NMIBC patients, reduce the risk of tumor recurrence, decrease the proportion of radical bladder surgery, and improve the quality of life of patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation, signing a written informed consent form;
- •The age on the date of signing the informed consent form should be no less than 18 years old, regardless of gender;
- •The subjects have completed the standard TURBT procedure before signing the informed consent form, and no obvious residual tumor lesions were found in the surgical field;
- •The postoperative pathology clearly diagnosed as non-muscle-invasive bladder cancer, and the main tissue component was more than 50% urothelial carcinoma (transitional cell carcinoma);
- •The subjects were classified into the intermediate-risk or high-risk group according to the risk classification for NMIBC;
- •Tumor tissue samples for TURBT must be provided, along with the required relevant pathological reports. Fresh surgical tissues or pathological slides can be sent for examination as well;
- •The patients were intolerant to BCG or did not accept the BCG infusion treatment plan;
- •Before treatment, HER2 detection was conducted on the resection specimens in the laboratory: The IHC results confirmed HER2 expression (defined as: IHC 1+, 2+ or 3+);
- •Clinical non-metastatic bladder cancer (N0, M0) was determined by abdominal computed tomography (CT).
排除标准
- •History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment;History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment;
- •Imaging results within 3 months before treatment indicated lymph node or other site/organ metastasis;
- •Imaging results within 3 months before treatment indicated the presence of other urinary system tumors;
- •Received other systemic anti-cancer treatments within 3 weeks before treatment, including chemotherapy, biological therapy, immunotherapy, targeted therapy, endocrine therapy, and/or investigational drug therapy;
- •Received bladder radiotherapy for urothelial carcinoma before treatment;
- •Known to have anaphylaxis or delayed allergic reaction to certain components of vedacitinib or similar drugs;
- •Within the 3 days prior to the first infusion, the following conditions had not yet been alleviated to CTCAE grade 1:Uncontrolled acute or chronic infections, such as pneumonia, biliary tract infections;Hepatitis B and Hepatitis C infections; dyspnea;Acute or chronic kidney injury; nephrotic syndrome; bladder perforation; urinary tract obstruction;
- •NYHA rating of 3 or 4;
- •Symptoms and signs related to cardiovascular diseases: including myocardial infarction, congestive heart failure, arrhythmia, etc.;
- •Known cerebrovascular accidents;
- •History of autoimmune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, hemolytic anemia, rheumatoid arthritis, etc.);
- •Known positive HIV serology, Hepatitis C infection and/or Hepatitis B (HepBsAg or core antibody positive and responding after antiviral treatment for Hepatitis B, except for these patients: these patients are allowed to participate in this study; Note: Patients with negative HepBsAg at screening)
研究组 & 干预措施
Disitamab Vedotin Plus Intravesical Mitomycin C
Experimental
Participants will receive intravenous disitamab vedotin in combination with intravesical mitomycin C according to the protocol-defined treatment schedule.
干预措施: Disitamab Vedotin (Drug)
Disitamab Vedotin Plus Intravesical Mitomycin C
Experimental
Participants will receive intravenous disitamab vedotin in combination with intravesical mitomycin C according to the protocol-defined treatment schedule.
干预措施: Mitomycin C (MMC) (Drug)
结局指标
主要结局
1-year disease-free survival rate(1-year DFS rate)
时间窗: At 12 months after the first study treatment.
defined as the time from study treatment initiation to disease recurrence (confirmed by cystoscopic biopsy or imaging), disease progression (muscle invasion or distant metastasis), or death from any cause, estimated by the Kaplan-Meier method.
次要结局
- Disease-free survival(From drug combination to the first documented recurrence, disease progression, death from any cause, or last follow-up, assessed up to 12 months.)
- Overall Survival（OS）(From the date of first study treatment to the date of death from any cause or last known follow-up, whichever occurred first, assessed up to 12 months.)
- Incidence and Severity of Treatment-emergent Adverse Events(From the date of first study treatment until 30 days after the last dose of study treatment, assessed up to 12 months.)
研究者
hanxuebin
Director of Urology Department
Shanxi Province Cancer Hospital
研究点 (1)
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