切除不能な超高リスク非筋層浸潤性膀胱癌に対する尿中腫瘍DNAガイド全身免疫療法

実験的：研究グループ

薬：Systemic immunotherapy

Participants receive systemic immune checkpoint inhibitor-based therapy administered intravenously every 3 weeks for an initial 3 cycles. Treatment response is initially assessed using transurethral resection of bladder tumor (TURBT) to evaluate pathologic stage. Participants without progression to muscle-invasive or metastatic disease subsequently undergo post-TURBT urine cytology and urinary tumor DNA (utDNA) testing. Participants with both negative urine cytology and negative utDNA results receive an additional 3 cycles of systemic immunotherapy.

Following the additional treatment, participants undergo repeat evaluation using cystoscopy with biopsy, urine cytology, and utDNA testing. Participants with negative findings on cystoscopic biopsy, urine cytology, and utDNA testing discontinue systemic immunotherapy and enter an active surveillance phase with regular follow-up monitoring. Participants who do not meet these criteria continue further clinical management and follow-up accord

Event-Free Survival

Event-free survival is defined as the time from initiation of systemic immunotherapy to the first occurrence of any of the following events after entry into the active surveillance phase: histologically confirmed intravesical recurrence of urothelial carcinoma, progression to muscle-invasive bladder cancer (≥T2 disease), regional lymph node or distant metastasis identified on chest or abdominopelvic computed tomography (CT), radical cystectomy, or death from any cause..

Residual non-muscle-invasive bladder cancer identified during the initial TURBT-based response assessment is not considered an event. Isolated urinary tumor DNA (utDNA) positivity without pathologically confirmed disease recurrence or progression is not considered an event.

根治的膀胱全摘除術を要しない生存

根治的膀胱全摘除術フリー生存期間は、全身的免疫療法の初回投与から、根治的膀胱全摘除術またはあらゆる原因による死亡のいずれかの初回発生までの期間として定義されます。

全生存期間

全生存期間は、全身免疫療法の初回投与からあらゆる原因による死亡までの時間と定義されます。

Duration of Complete Response

Duration of complete response is defined, among participants who achieve confirmed complete clinical response (cCR) at repeat evaluation after additional systemic immunotherapy, as the time from the first documentation of confirmed cCR to the first occurrence of any of the following events: histologically confirmed intravesical recurrence of urothelial carcinoma, progression to muscle-invasive bladder cancer (≥T2 disease), regional lymph node or distant metastasis identified on imaging evaluation, radical cystectomy, or death from any cause.

Confirmed complete clinical response is defined as negative findings on cystoscopy with biopsy, negative urine cytology, negative urinary tumor DNA (utDNA), and absence of muscle-invasive, nodal, or metastatic disease on chest and abdominopelvic computed tomography (CT).

Isolated urinary tumor DNA (utDNA) positivity without pathologically confirmed disease recurrence or radiographically confirmed progression is not considered an event.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as the time from the first dose of study treatment up to 30 days after last dose of study treatment or 1 day before start day of new anti-cancer therapy.

EORTC QLQ-C30

To assess disease-related symptoms and HRQoL

EORTC QLQ-NMIBC24

To assess disease-related symptomd and HRQoL

EQ-5L

To assess disease-related symptoms and HRQoL