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El ensayo clínico NCT07470840 para Carcinoma de Células Renales Localmente Avanzado o Metastásico 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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SBRT Plus Anlotinib and Bimepolizumab in Locally Advanced or Metastatic Renal Cell Carcinoma Fase II 27
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 NCT07470840 está diseñado para estudiar el tratamiento de Carcinoma de Células Renales Localmente Avanzado o Metastásico. Este es un estudio intervencionista de Fase II. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de febrero de 2027 hasta completar 27 participantes. Dirigido por Fujian Cancer Hospital, se espera que finalice el 1 de junio de 2029. Los datos se actualizaron por última vez en ClinicalTrials.gov el 24 de marzo de 2026.
Resumen
To investigate the objective response rate (ORR) of stereotactic body radiotherapy (SBRT) combined with anlotinib and beromuzumab in locally advanced/metastatic renal cell carcinoma.
Título oficial
A Phase II Multicenter Study of Stereotactic Body Radiation Therapy (SBRT) Combined With Anlotinib and Bimepolizumab in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
Condiciones médicas
Carcinoma de Células Renales Localmente Avanzado o MetastásicoOtros ID del estudio
- BEAM-R
Número del NCT
Inicio del estudio (real)
2027-02-01
Última actualización
2026-03-24
Fecha de finalización (estimada)
2029-06-01
Inscripción (prevista)
27
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Aún no recluta
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalSBRT combined with Anlotinib and Bemarituzumab Interventions:
1. Radiation: stereotactic body radiotherapy (SBRT)
2. Drug: Anlotinib
3. Drug: Bemarituzumab | Stereotactic Body Radiation Therapy (SBRT) Dose fractionation: 39-48Gy/3f or 40-50Gy/5f, alternative 20-50Gy/5f if OAR dose-limited. Dose adjusted per radiation toxicities during treatment. Anlotinib Oral anti-angiogenic agent, 12 mg qd fasting, 21d/cycle (2w on/1w off) Bemarituzumab Intravenous PD-1 inhibitor, 1200 mg q3w, 60min infusion |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Objective Response Rate (ORR) | Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and at regular intervals during consolidation therapy follow-up throughout the study, from enrollment to 36 month. |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Progression-Free Survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | |
Disease Control Rate (DCR) | Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and regular follow-up during consolidation therapy, from enrollment to 36 month. | |
Overall Survival (OS) | Followed up for the entire study period until patient death or study conclusion, from enrollment to 36 month. | |
Objective Response Rate in the Field of Irradiation | Assessed at baseline, post-SBRT (before the 2nd cycle of targeted-immunotherapy) and regular follow-up during consolidation therapy, from enrollment to 36 month.. | |
Objective response rate (ORR) of irradiated versus non-irradiated lesions assessed by RECIST v1.1 | Baseline, before cycle 2 and cycle 4 of immunotherapy (each cycle is 21 days), and up to 36 months. | |
Incidence of treatment-related adverse events (TRAEs) assessed by CTCAE v5.0 | From baseline through study treatment period, up to 2 years. |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Aged 18 to 80 years, regardless of sex.
- Histologically or cytologically confirmed locally advanced/metastatic renal cell carcinoma (RCC) inoperable/refused for surgery, or post-operative locally recurrent/metastatic RCC; pathological types include clear cell carcinoma and papillary renal cell carcinoma.
- ECOG performance status 0 or 1.
- At least 50% of all evaluable metastatic lesions are eligible for stereotactic body radiation therapy (SBRT).
- No contraindications to radiotherapy, targeted therapy or immunotherapy.
- At least one radiologically measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Capable and willing to comply with the study protocol including scheduled visits, treatment plan, laboratory tests and other study-related procedures during the study period.
- Signed written informed consent form.
- With contraindications to targeted or immunotherapeutic drugs.
- A history of other malignant diseases in the recent 5 years, except for cured skin cancer and carcinoma in situ of the cervix.
- With active autoimmune diseases, organ transplantation, or other diseases requiring immunosuppressive therapy or long-term hormone therapy.
- Extensive diffuse metastasis with an expected survival of less than 3 months.
- A history of uncontrolled epilepsy, central nervous system diseases or mental disorders, whose clinical severity is judged by the investigator to potentially hinder the signing of the informed consent form or affect the patient's compliance with oral medication.
- With severe uncontrolled recurrent infections or other serious uncontrolled concomitant diseases.
- Allergic to any component of the study drugs.
- The subject's baseline blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥80g/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet ≥100×10⁹/L; ALT and AST ≤2.5 times the upper limit of normal; serum total bilirubin <1.5 times the upper limit of normal; serum creatinine <2 times the upper limit of normal.
Fujian Cancer HospitalContactos centrales del estudio
Contacto: Jinluan Li, MD, +86-15159628678, [email protected]
Contacto: Shushang Chen, MD, +86-18960939103, [email protected]
1 Centros del estudio en 1 países
Fujian
Fujian Cancer Hospital, Fuzhou, Fujian, 350014, China
Jinluan Li, MD, Contacto, +86-15959628678, [email protected]
Shushang Shu, MD, Contacto, +86-18960939103, [email protected]
Jinluan Li, MD, Investigador principal
Shushang Chen, MD, Investigador principal