即将开始 NCT07907575

ERBT联合辅助膀胱内诱导及维持化疗在中危NMIBC中的作用

膀胱癌/尿路上皮癌不适用III 期

这是一项前瞻性、多中心随机试验,比较ERBT联合为期1年的Ad-MMC与单独ERBT在中危NMIBC治疗中的效果。

适应症:Bladder Cancer

入组条件

纳入标准

  • Age ≥ 18 years old with informed consent
  • ERBT was successfully performed with clear resection margins
  • Histologically confirmed intermediate-risk NMIBC
  • Patients who are ineligible or refused to undergo intravesical BCG therapy

排除标准

  • Any prior use of intravesical induction and/or maintenance chemotherapy instillations
  • Any prior use of intravesical BCG therapy
  • Presence or prior history of upper urinary tract malignancy
  • Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block) (20)
  • Presence of GOLD Stage III or IV chronic obstructive pulmonary disease (21)
  • ECOG performance status ≥ 2 (Ambulatory and capable of all self-care but unable to carry our any work activities)
  • Pregnancy
  • Presence of other active malignancy

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年11月5日。