Is Prolonged Systemic Immunotherapy Necessary After Achieving Tumor-free Status in Patients With Extensive Transurethrally Unresectable Very-high-risk NMIBC?
28 de mayo de 2026 actualizado por: Tianjin Medical University Second Hospital
Randomized Trial of Active Surveillance Versus Continued Systemic Immunotherapy After Achieving Tumor-Free Status in Extensive Transurethrally Unresectable Very-High-Risk NMIBC
Patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC) may achieve a tumor-free status after systemic immunotherapy-based bladder-sparing treatment combined with transurethral resection of bladder tumor (TURBT). However, the optimal duration of systemic immunotherapy after achieving a tumor-free status remains uncertain. Prolonged treatment may increase toxicity, treatment burden, and cost, while some patients may maintain durable disease control without continued therapy.
This randomized study aims to evaluate whether active surveillance after achieving tumor-free status is a feasible alternative to continued systemic immunotherapy in patients with extensive transurethrally unresectable very-high-risk NMIBC.
Patients will initially receive systemic immunotherapy-based treatment followed by disease evaluation using cystoscopy with biopsy and/or TURBT, urine cytology, urinary tumor DNA (utDNA), and imaging assessments. Patients who achieve tumor-free status after treatment and complete resection of visible disease will be randomized to either active surveillance or continued systemic immunotherapy.
The study will evaluate recurrence outcomes, bladder preservation, progression, safety, and patient management strategies following achievement of tumor-free status. The trial also aims to explore the role of urinary tumor DNA in identifying patients who may safely undergo treatment de-escalation and active surveillance.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
120
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Hailong Hu, MD
- Número de teléfono: +8619801518556
- Correo electrónico: huhailong@tmu.edu.cn
Copia de seguridad de contactos de estudio
- Nombre: Yunkai Qie, MD
- Correo electrónico: qieyunkai@tmu.edu.cn
Ubicaciones de estudio
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Tianjin, Porcelana
- General Hospital of Tianjin Medical University
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Contacto:
- Liang Wang
- Número de teléfono: +8615620530409
- Correo electrónico: wjlmnwk@163.com
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Tianjin, Porcelana, 300000
- The Second Hospital of Tianjin Medical University
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Contacto:
- Hailong Hu
- Número de teléfono: +8619801518556
- Correo electrónico: huhailong@tmu.edu.cn
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Tianjin, Porcelana
- Tianjin Hospital
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Contacto:
- Guangbin Zhu
- Número de teléfono: +8613903124399
- Correo electrónico: zgb2016@163.com
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Xingtai, Porcelana
- Xingtai People's Hospital
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Contacto:
- Junli Wei
- Número de teléfono: +8617299180245
- Correo electrónico: wjluro@163.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria
- Has histologically confirmed very-high-risk non-muscle-invasive urothelial carcinoma of the bladder.
- Has transurethrally unresectable bladder tumor, defined as visually incomplete TURBT and/or extensive high-volume disease considered unsuitable for complete and oncologically adequate transurethral resection.
- Has undergone cystoscopy and TURBT evaluation before study enrollment.
- Has received systemic PD-1/PD-L1 inhibitor-based bladder-sparing therapy before randomization.
Has achieved tumor-free status before randomization, defined as:
- No visible bladder tumor on cystoscopy;
- Negative bladder biopsy and/or TURBT pathology;
- Negative urine cytology;
- Negative urinary tumor DNA (utDNA);
- No radiographic evidence of progression or metastasis.
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Has adequate organ function.
- Has provided written informed consent.
Cohort A Only
- Achieved tumor-free status at the initial response evaluation after induction systemic therapy.
- Maintained tumor-free status after additional systemic therapy before randomization.
Cohort B Only
- Did not achieve tumor-free status at the initial response evaluation because of residual non-muscle-invasive disease.
- Subsequently underwent complete TURBT/resection of residual disease followed by additional systemic therapy.
- Achieved tumor-free status at the second response evaluation before randomization.
Exclusion Criteria
- Has muscle-invasive bladder cancer (≥T2), locally advanced unresectable disease, nodal disease, or distant metastasis.
- Has concurrent upper tract urothelial carcinoma.
- Has persistent visible tumor, positive bladder pathology, positive urine cytology, or positive utDNA before randomization.
- Has received prior systemic immunotherapy for metastatic urothelial carcinoma.
- Has active autoimmune disease requiring systemic treatment.
- Is receiving systemic immunosuppressive therapy.
- Has uncontrolled infection requiring systemic therapy.
- Has another active malignancy requiring systemic treatment.
- Has known active hepatitis B, hepatitis C, human immunodeficiency virus infection, or active tuberculosis.
- Has pregnancy or breastfeeding.
- Has any medical or psychiatric condition that, in the investigator's judgment, would interfere with study participation or interpretation of results.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Arm A-1 (Cohort A Active Surveillance)
Patients in Cohort A who achieve early tumor-free status after initial systemic immunotherapy-based treatment will undergo active surveillance with protocol-defined cystoscopy, urine cytology, urinary tumor DNA testing, biopsy as clinically indicated, and imaging assessments.
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Patients undergo protocol-defined surveillance after achieving tumor-free status, including cystoscopy, biopsy as clinically indicated, urine cytology, urinary tumor DNA testing, and imaging assessments, without continued systemic PD-1/PD-L1 inhibitor therapy unless disease recurrence or progression occurs.
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Comparador activo: Arm A-2 (Cohort A Continued Systemic Immunotherapy)
Patients in Cohort A who achieve early tumor-free status after initial systemic immunotherapy-based treatment will continue systemic immunotherapy for a protocol-defined duration with ongoing disease surveillance.
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Patients continue protocol-defined systemic PD-1/PD-L1 inhibitor therapy after achieving tumor-free status for up to approximately 1 year, with ongoing surveillance including cystoscopy, urine cytology, urinary tumor DNA testing, and imaging assessments.
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Experimental: Arm B-1 (Cohort B Active Surveillance)
Patients in Cohort B who do not achieve tumor-free status at initial evaluation but subsequently achieve tumor-free status after complete TURBT/resection and additional systemic immunotherapy will undergo active surveillance with protocol-defined surveillance assessments.
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Patients undergo protocol-defined surveillance after achieving tumor-free status, including cystoscopy, biopsy as clinically indicated, urine cytology, urinary tumor DNA testing, and imaging assessments, without continued systemic PD-1/PD-L1 inhibitor therapy unless disease recurrence or progression occurs.
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Comparador activo: Arm B-2 (Cohort B Continued Systemic Immunotherapy)
Patients in Cohort B who subsequently achieve tumor-free status after complete TURBT/resection and additional systemic immunotherapy will continue systemic immunotherapy for a protocol-defined duration with ongoing disease surveillance.
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Patients continue protocol-defined systemic PD-1/PD-L1 inhibitor therapy after achieving tumor-free status for up to approximately 1 year, with ongoing surveillance including cystoscopy, urine cytology, urinary tumor DNA testing, and imaging assessments.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Bladder-intact event-free survival (BI-EFS)
Periodo de tiempo: Up to 2 years from randomization
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Time from randomization to the first occurrence of high-risk NMIBC recurrence, progression to muscle-invasive bladder cancer, distant metastasis, radical cystectomy, or death from any cause.
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Up to 2 years from randomization
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recurrence-free survival (RFS)
Periodo de tiempo: Up to 2 years from randomization
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Time from randomization to the first documented recurrence of bladder cancer or death from any cause.
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Up to 2 years from randomization
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Progression-free survival (PFS)
Periodo de tiempo: Up to 2 years from randomization
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Time from randomization to progression to muscle-invasive, locally advanced, or metastatic bladder cancer, or death from any cause.
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Up to 2 years from randomization
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Radical cystectomy-free survival (RCFS)
Periodo de tiempo: Up to 2 years from randomization
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Time from randomization to radical cystectomy or death from any cause.
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Up to 2 years from randomization
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Overall survival (OS)
Periodo de tiempo: Up to 2 years from randomization
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Time from randomization to death from any cause.
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Up to 2 years from randomization
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Incidence of treatment-related adverse events
Periodo de tiempo: Up to 2 years from randomization
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Proportion of patients experiencing treatment-related adverse events, graded according to CTCAE.
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Up to 2 years from randomization
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recurrence-Free Survival According to Urinary Tumor DNA Status
Periodo de tiempo: Up to 2 years from randomization
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Recurrence-free survival will be evaluated according to urinary tumor DNA status after achieving tumor-free status.
Urinary tumor DNA status will be assessed using a urine-based tumor DNA assay and categorized as positive or negative.
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Up to 2 years from randomization
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utDNA conversion during surveillance
Periodo de tiempo: Up to 2 years from initial systemic administration
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Proportion of patients with conversion from urinary tumor DNA negative to positive during follow-up.
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Up to 2 years from initial systemic administration
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Bladder-Intact Event-Free Survival According to Response Cohort in the Active Surveillance Arm
Periodo de tiempo: Up to 2 years from randomization
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Bladder-intact event-free survival will be compared between participants assigned to active surveillance in Cohort A and Cohort B.
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Up to 2 years from randomization
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Recurrence-Free Survival According to Response Cohort in the Active Surveillance Arm
Periodo de tiempo: Up to 2 years from randomization
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Recurrence-free survival will be compared between participants assigned to active surveillance in Cohort A and Cohort B.
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Up to 2 years from randomization
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Bladder-Intact Event-Free Survival According to Response Cohort in the Continued Systemic Immunotherapy Arm
Periodo de tiempo: Up to 2 years from randomization
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Bladder-intact event-free survival will be compared between participants assigned to continued systemic immunotherapy in Cohort A and Cohort B.
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Up to 2 years from randomization
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Recurrence-Free Survival According to Response Cohort in the Continued Systemic Immunotherapy Arm
Periodo de tiempo: Up to 2 years from randomization
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Recurrence-free survival will be compared between participants assigned to continued systemic immunotherapy in Cohort A and Cohort B.
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Up to 2 years from randomization
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Hailong Hu, MD, Department of Urology, The Second Hospital of Tianjin Medical University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de mayo de 2026
Finalización primaria (Estimado)
30 de marzo de 2029
Finalización del estudio (Estimado)
30 de mayo de 2032
Fechas de registro del estudio
Enviado por primera vez
21 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de mayo de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Neoplasias urogenitales
- Neoplasias por sitio
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Neoplasias Urológicas
- Carcinoma
- Enfermedades de la vejiga urinaria
- Neoplasias de la vejiga urinaria
- Neoplasias vesicales sin invasión muscular
- Neoplasias
- Administración de Servicios de Salud
- Calidad de la atención médica
- Evaluación de resultados, atención médica
- Evaluación de resultados y procesos, atención médica
- Esperanza vigilante
Otros números de identificación del estudio
- Truce-LB03
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .