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。