Lenvatinib Plus Chemotherapy for pNET Liver Metastases (LEN-pNET)
A Study of Second-Line Treatment Response and Resistance Mechanisms in Pancreatic Neuroendocrine Tumors With Liver Metastases Based on cfDNA and Single-Cell PBMC Multi-omics
This prospective, non-randomized, concurrent parallel-controlled study will evaluate treatment response and resistance mechanisms in patients with pancreatic neuroendocrine tumors with liver metastases (pNET-LM) receiving second-line systemic therapy after failure of first-line treatment.
Eligible patients will receive either lenvatinib combined with chemotherapy or chemotherapy alone according to the study protocol and clinical treatment strategy. The clinical efficacy and safety of the two treatment strategies will be evaluated using objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events.
Peripheral blood samples will be collected before treatment, during early treatment, and at disease progression. Circulating cell-free DNA (cfDNA) and peripheral blood mononuclear cells (PBMCs) will be analyzed to investigate molecular and immune changes associated with treatment response, primary resistance, and acquired resistance. The study aims to identify potential biomarkers for predicting treatment response and to improve understanding of resistance mechanisms in pNET-LM.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100000
- Reclutamiento
- Chinese Academy of Medical Sciences，Peking Union Medical College Hospital
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Contacto:
- Jiayue Li
- Número de teléfono: 86+010-6915687
- Correo electrónico: 1624271942@qq.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Inclusion Criteria:
- Age 18 to 75 years.
- Histologically or cytologically confirmed pancreatic neuroendocrine tumor.
- Radiologically confirmed liver metastases.
- Disease progression or treatment failure after first-line systemic therapy, with eligibility for second-line treatment.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic, hepatic, and renal function as assessed by the investigator.
- Life expectancy of at least 12 weeks.
- Ability to understand and willingness to sign a written informed consent form.
Exclusion Criteria:
- Poorly differentiated neuroendocrine carcinoma or neuroendocrine tumor originating from a site other than the pancreas.
- Previous treatment with lenvatinib.
- Uncontrolled or clinically significant cardiovascular disease, including uncontrolled hypertension.
- Active severe infection or other uncontrolled serious systemic disease.
- Known central nervous system metastases that are symptomatic or uncontrolled.
- Pregnancy or breastfeeding.
- Participation in another interventional clinical study that may interfere with the outcomes of this study.
- Any other condition that, in the opinion of the investigator, may make the participant unsuitable for participation in this study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Chemotherapy Alone
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Chemotherapy will be administered according to the study protocol and clinical characteristics of the participant. The chemotherapy regimen may include an etoposide-platinum regimen or capecitabine plus temozolomide, as specified in the study protocol. |
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Experimental: Lenvatinib Plus Chemotherapy
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Lenvatinib will be administered as part of second-line treatment in combination with chemotherapy according to the study protocol. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Objective Response Rate (ORR)
Periodo de tiempo: From treatment initiation until disease progression, death, or up to 24 months
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Objective response rate is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as their best overall response, as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
From treatment initiation until disease progression, death, or up to 24 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Progression-Free Survival (PFS)
Periodo de tiempo: From treatment initiation until disease progression or death, whichever occurs first, assessed up to 24 months
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Progression-free survival is defined as the time from treatment initiation to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. |
From treatment initiation until disease progression or death, whichever occurs first, assessed up to 24 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NET001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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