절제 불가능한 초고위험 비근육침윤성 방광암에 대한 요로 종양 DNA 기반 전신 면역요법

실험적: 스터디 그룹

의약품: 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.

근치적 방광절제술-무병 생존

근치적 방광절제술 무발생 생존기간은 전신 면역요법의 첫 투여 시점부터 근치적 방광절제술의 첫 발생 또는 모든 원인에 의한 사망 중 먼저 발생한 시점까지의 기간으로 정의됩니다.

전체 생존율

전체 생존율은 전신 면역요법의 첫 투여 시점부터 모든 원인으로 인한 사망까지의 기간으로 정의됩니다.

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