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El ensayo clínico NCT07498907 (LUXUS41) para Carcinoma urotelial del tracto superior está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma (LUXUS41) Fase II 192 Aleatorizado Etiqueta abierta Supervivencia global
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07498907 (LUXUS41) está diseñado para estudiar el tratamiento de Carcinoma urotelial del tracto superior. Este es un estudio intervencionista de Fase II. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de mayo de 2026 hasta completar 192 participantes. Dirigido por Peking University First Hospital, se espera que finalice el 1 de marzo de 2034. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen
This randomized, open-label, multicenter phase II study is designed to compare disitamab vedotin plus radiotherapy with gemcitabine plus carboplatin as adjuvant treatment in patients with HER2-expressing upper tract urothelial carcinoma after radical nephroureterectomy (RNU). Eligible patients must have postoperative pathologic stage pT3-pT4N0M0 or pTanyN+M0, HER2 expression defined as immunohistochemistry (IHC) 1+, ...Mostrar más
Título oficial
A Randomized, Prospective, Multicenter, Phase II Study of Disitamab Vedotin Plus Radiotherapy as Adjuvant Treatment for HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
Condiciones médicas
Carcinoma urotelial del tracto superiorOtros ID del estudio
- LUXUS41
- LUXUS4.1
Número del NCT
Inicio del estudio (real)
2026-05-01
Última actualización
2026-03-27
Fecha de finalización (estimada)
2034-03-01
Inscripción (prevista)
192
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Aún no recluta
Palabras clave
UTUC
HER2
Disitamab Vedotin
Radiotherapy
Adjuvant Therapy
Cisplatin-Ineligible
Upper Tract Urothelial Carcinoma
HER2
Disitamab Vedotin
Radiotherapy
Adjuvant Therapy
Cisplatin-Ineligible
Upper Tract Urothelial Carcinoma
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalDisitamab Vedotin Plus Radiotherapy Participants in this arm will receive disitamab vedotin plus radiotherapy as adjuvant treatment after radical surgery for HER2-expressing,cisplatin-ineligible upper tract urothelial carcinoma. | Disitamab Vedotin (RC48) Disitamab vedotin 2.0 mg/kg (maximum 120 mg) will be administered intravenously every 2 weeks for 12 cycles as adjuvant treatment after radical surgery. Radioterapia Adjuvant radiotherapy will be delivered to the regional lymphatic drainage area at 45-50 Gy in 25 fractions over 5 weeks. Suspicious lymph nodes will receive 62.5 Gy in 25 fractions over 5 weeks. |
Comparador activoGemcitabine Plus Carboplatin Participants in this arm will receive gemcitabine plus carboplatin as adjuvant treatment after radical surgery for HER2-expressing cisplatin-ineligible upper tract urothelial carcinoma. | Gemcitabine (1000 mg/m2) Gemcitabine 1000 mg/m² will be administered on Days 1 and 8 of each 21-day cycle for 4 to 6 cycles as adjuvant treatment after radical surgery. Carboplatino Carboplatin will be administered intravenously on Day 1 of each 21-day cycle at a target AUC of 4.5 to 5 for 4 to 6 cycles as adjuvant treatment after radical surgery. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
3-Year Disease-Free Survival | Disease-free survival (DFS) is defined as the time from randomization to first recurrence in the tumor bed, first metastasis, or death from any cause, whichever occurs first. | From randomization up to 3 years |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Overall Survival | Overall survival (OS) is defined as the time from randomization to death from any cause. | From randomization up to 3 years |
Metastasis-Free Survival | Metastasis-free survival (MFS) is defined as the time from randomization to first documented distant metastasis or death from any cause, whichever occurs first. | From randomization up to 3 years |
Local Recurrence-Free Survival | Local recurrence-free survival (LRFS) is defined as the time from randomization to first documented locoregional recurrence in the tumor bed or regional lymph nodes, or death from any cause, whichever occurs first. | From randomization up to 3 years |
Bladder Recurrence-Free Survival | Bladder recurrence-free survival (BRFS) is defined as the time from randomization to first documented bladder urothelial recurrence or death from any cause, whichever occurs first | From randomization up to 3 years |
Incidence of Adverse Events | Safety will be evaluated based on the incidence, type, severity, and attribution of adverse events during study treatment and follow-up. | From first dose through 30 days after completion of study treatment and up to 3 years for follow-up |
Patient-Reported Quality of Life | Patient-reported quality of life will be assessed using validated quality-of-life questionnaires during treatment and follow-up. | Baseline through 3 years |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Aged 18 years or older.
- Histologically confirmed upper tract urothelial carcinoma (UTUC) after radical nephroureterectomy (RNU).
- Postoperative pathologic stage pT3-pT4N0M0 or pTanyN+M0.
- HER2 expression confirmed by immunohistochemistry (IHC 1+, 2+, or 3+).
- Cisplatin-ineligible, defined as meeting at least one of the following criteria: ECOG performance status 2; creatinine clearance <60 mL/min; CTCAE grade 2 or higher hearing loss; CTCAE grade 2 or higher peripheral neuropathy; or New York Heart Association (NYHA) class III heart failure.
- Adequate organ function.
- Expected survival of at least 6 months.
- History of other active malignancies, except for adequately treated malignancies with low risk of recurrence.
- Prior systemic antitumor therapy before study treatment, or unresolved toxicities from prior therapy.
- Known hypersensitivity to disitamab vedotin, related agents, or any component of the study treatment.
- Severe active infection.
- Not adequately recovered from surgery.
- Pregnant or breastfeeding women.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
Peking University First HospitalRemeGen Co., Ltd.Contactos centrales del estudio
Contacto: Xuesong Li, Dr., 010-83572418, [email protected]
Contacto: Zihao Tao, Dr., [email protected]
1 Centros del estudio en 1 países
Peking University First Hospital, Beijing, China
Xuesong Li, Dr., Contacto, 010-83572418, [email protected]
Qi Tang, Dr., Contacto, [email protected]