一项在接受过卡介苗(BCG)治疗后复发且不适合或选择不进行根治性膀胱切除术的高危非肌层浸润性膀胱癌(HR-NMIBC)受试者中评价TAR-200较研究者选择的膀胱内化疗的疗效和安全性的III期、随机、开放性、多中心研究
[Translation] A study evaluating TAR-200 versus Investigator's Choice in subjects with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who relapsed after Bacillus Calmette-Guerin (BCG) therapy and were not candidates for or chose not to undergo radical cystectomy A phase III, randomized, open-label, multicenter study of the efficacy and safety of intravesical chemotherapy
主要目的是在BCG治疗末次给药后1年内出现单纯乳头状HR-NMIBC复发且拒绝或不适合接受根治性膀胱切除术(RC)的受试者中,比较接受TAR-200治疗与研究者选择的单药膀胱内化疗的无疾病生存期。
[Translation] The primary objective is to compare treatment with TAR-200 versus investigator's choice in subjects with simple papillary HR-NMIBC recurrence within 1 year of the last dose of BCG therapy who refuse or are not eligible for radical cystectomy (RC). Disease-free survival of single-agent intravesical chemotherapy.
一项在未接受过BCG治疗的高危非肌层浸润性膀胱癌(HR-NMIBC)受试者中评价TAR-200联合Cetrelimab治疗或TAR-200单药治疗对比膀胱内卡介苗(BCG)治疗的疗效和安全性的III期、开放性、多中心、随机研究
[Translation] A study evaluating the efficacy of TAR-200 in combination with Cetrelimab or TAR-200 monotherapy versus intravesical Bacillus Calmette-Guerin (BCG) in BCG-naïve subjects with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) Phase III, open-label, multicenter, randomized study of and safety
在未接受过BCG治疗的HR-NMIBC(高级别乳头状Ta、任何T1或原位癌[CIS])受试者中,对比接受TAR-200+IV Cetrelimab治疗(组A)和TAR-200单药治疗(组C)与膀胱内BCG治疗(组B)的无事件生存期(EFS)。
[Translation] In BCG-naïve HR-NMIBC (high-grade papillary Ta, any T1, or carcinoma in situ [CIS]) subjects, compared TAR-200+IV cetrelimab treatment (group A) with TAR-200 alone Event-free survival (EFS) of drug therapy (group C) versus intravesical BCG therapy (group B).
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