即將開始 NCT07724886

ERBT 聯合膀胱內 BCG 於中風險或高風險 NMBC 中的角色

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,於中風險或高風險 NMIBC 患者中比較 cTURBT 聯合 1 年 BCG 治療與 ERBT 聯合 1 年 BCG 治療。

適應症:Bladder Cancer

收案條件

納入條件

  • Age 18 years or above
  • Fulfil any one of the following three criteria:
  • Recurrent bladder tumour
  • Multiple bladder tumours
  • Any bladder tumour size of \>1cm

排除條件

  • EAU low-risk NIMBC as intravesical BCG therapy should not be offered (5)
  • EAU very high-risk NMIBC as upfront radical cystectomy should be offered (5)
  • 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) (16)
  • Presence of GOLD Stage III or IV chronic obstructive pulmonary disease
  • ECOG performance status ≥ 2 (Ambulatory and capable of all self-care but unable to carry our any work activities) (18)
  • History of bleeding disorder or use of anti-coagulants
  • 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10月8日。