即将开始 NCT07724886

ERBT 联合膀胱内 BCG 于中风险或高风险 NMBC 中的角色

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,于中风险或高风险 NMIBC 患者中比较 cTURBT 联合 1 年 BCG 治疗与 ERBT 联合 1 年 BCG 治疗。

适应症:Bladder Cancer

入组条件

纳入标准

  • 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

排除标准

  • 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

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10月8日。