即將開始 NCT07907575

ERBT聯合輔助膀胱內誘導及維持化療在中危NMIBC中的作用

膀胱癌/泌尿道上皮癌不適用III 期

這是一項前瞻性、多中心隨機試驗,比較ERBT聯合為期1年的Ad-MMC與單獨ERBT在中危NMIBC治療中的效果。

適應症:Bladder Cancer

收案條件

納入條件

  • 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

排除條件

  • 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

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年11月5日。