A Randomized, Prospective, Multicenter, Phase III Study of Disitamab Vedotin Plus Radiotherapy as Adjuvant Treatment for HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- 3-Year Disease-Free Survival
研究概览
简要总结
This randomized, open-label, multicenter phase III study is designed to compare disitamab vedotin plus radiotherapy with gemcitabine plus carboplatin as adjuvant treatment in patients with HER2-expressing upper tract urothelial carcinoma after radical nephroureterectomy (RNU). Eligible patients must have postoperative pathologic stage pT3-pT4N0M0 or pTanyN+M0, HER2 expression defined as immunohistochemistry (IHC) 1+, 2+, or 3+, and be cisplatin-ineligible. Patients will be randomized in a 2:1 ratio to receive disitamab vedotin plus radiotherapy or gemcitabine plus carboplatin. The primary endpoint is 3-year disease-free survival. Secondary endpoints include overall survival, metastasis-free survival, local recurrence-free survival, bladder recurrence-free survival, incidence of adverse events, and patient-reported quality of life.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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
- Aged 18 years or older.
- Histologically confirmed upper tract urothelial carcinoma (UTUC) after radical nephroureterectomy (RNU).
- Postoperative pathologic stage pT3-pT4N0M0 or pTanyN+M0.
- HER2 expression confirmed by immunohistochemistry (IHC 1+, 2+, or 3+).
- Cisplatin-ineligible, defined as meeting at least one of the following criteria: ECOG performance status 2; creatinine clearance <60 mL/min; CTCAE grade 2 or higher hearing loss; CTCAE grade 2 or higher peripheral neuropathy; or New York Heart Association (NYHA) class III heart failure.
- Adequate organ function.
- Expected survival of at least 6 months.
排除标准
- History of other active malignancies, except for adequately treated malignancies with low risk of recurrence.
- Prior systemic antitumor therapy before study treatment, or unresolved toxicities from prior therapy.
- Known hypersensitivity to disitamab vedotin, related agents, or any component of the study treatment.
- Severe active infection.
- Not adequately recovered from surgery.
- Pregnant or breastfeeding women.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
研究组 & 干预措施
Disitamab Vedotin Plus Radiotherapy
Participants in this arm will receive disitamab vedotin plus radiotherapy as adjuvant treatment after radical surgery for HER2-expressing,cisplatin-ineligible upper tract urothelial carcinoma.
干预措施: Disitamab Vedotin (RC48) (Drug)
Disitamab Vedotin Plus Radiotherapy
Participants in this arm will receive disitamab vedotin plus radiotherapy as adjuvant treatment after radical surgery for HER2-expressing,cisplatin-ineligible upper tract urothelial carcinoma.
干预措施: radiotherapy (Radiation)
Gemcitabine Plus Carboplatin
Participants in this arm will receive gemcitabine plus carboplatin as adjuvant treatment after radical surgery for HER2-expressing cisplatin-ineligible upper tract urothelial carcinoma.
干预措施: Gemcitabine (1000 mg/m2) (Drug)
Gemcitabine Plus Carboplatin
Participants in this arm will receive gemcitabine plus carboplatin as adjuvant treatment after radical surgery for HER2-expressing cisplatin-ineligible upper tract urothelial carcinoma.
干预措施: carboplatin (Drug)
结局指标
主要结局
3-Year Disease-Free Survival
时间窗: From randomization up to 3 years
Disease-free survival (DFS) is defined as the time from randomization to first recurrence in the tumor bed, first metastasis, or death from any cause, whichever occurs first.
次要结局
- Overall Survival(From randomization up to 3 years)
- Metastasis-Free Survival(From randomization up to 3 years)
- Local Recurrence-Free Survival(From randomization up to 3 years)
- Bladder Recurrence-Free Survival(From randomization up to 3 years)
- Incidence of Adverse Events(From first dose through 30 days after completion of study treatment and up to 3 years for follow-up)
- Patient-Reported Quality of Life(Baseline through 3 years)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07498907
- 其他研究编号
- LUXUS4.1
日期
- 首次提交
- (6个月前)
- 首次发布
- (6个月前)
- 主要完成日期
- (2年后)
- 研究完成日期
- (7年后)
- 最近核实
- (7个月前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否