- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07581769
Radiomics Subtyping to Guide Surgery vs. Maintenance Therapy After HCC Downstaging
A Retrospective Radiomics-Based Subtyping Study to Guide Post-Downstaging Treatment Selection in Patients With Unresectable Hepatocellular Carcinoma Following TACE Plus Lenvatinib and Anti PD-1
The goal of this observational study is to learn about the long-term treatment outcomes for patients with initially unresectable hepatocellular carcinoma (HCC) who achieve successful downstaging with the combination therapy of TACE, lenvatinib, and a PD-1 inhibitor. The main questions it aims to answer are:
Can distinct disease subtypes be identified in successfully downstaged patients using radiomics and clinical data?
Do these different subtypes show significant differences in long-term outcomes, such as recurrence-free survival and overall survival, after undergoing either curative-intent surgical resection or continuing maintenance therapy?
Based on the identified subtypes, can the investigators objectively determine which patients are more suitable for surgical resection and which patients may benefit more from continued maintenance therapy after successful downstaging?
The study will include patients who have already undergone the combination therapy as part of their regular medical care, successfully achieved tumor downstaging (making the tumor technically resectable), and subsequently received either surgical resection or continued maintenance treatment. Researchers will retrospectively analyze their existing clinical and imaging data to compare long-term outcomes between these two treatment paths based on their identified disease subtype.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510280
- ZhuJiang Hospital of Southern Medical University
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Guangzhou, Guangdong, Porcelana, 510080
- The First Affiiated Hospital of Sun Yat-sen University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients diagnosed with hepatocellular carcinoma (HCC) based on clinical or pathological criteria;
- Barcelona Clinic Liver Cancer (BCLC) stage B or C, assessed as unresectable by surgical evaluation; Underwent treatment with TACE combined with lenvatinib and a PD-1 inhibitor, after which the tumor was re-evaluated and deemed resectable by surgical assessment;
- Following the achievement of surgical resectability criteria, patients subsequently underwent either R0 surgical resection or continued treatment with TACE combined with lenvatinib and a PD-1 inhibitor;
- Liver function classified as Child-Pugh Class A or B, or achieved this standard after medical treatment;
- Performance status (PS) score of 0 or 1.
Exclusion Criteria:
- Patients with unclear diagnoses or those with concurrent other malignancies.
- For patients in the downstaging surgery group: Those who underwent non-R0 resection or received additional anti-tumor therapies postoperatively.
- For patients in the maintenance treatment group: Those who received anti-tumor therapies other than TACE/lenvatinib/PD-1 inhibitors.
- Liver function classified as Child-Pugh Class C or above, unresponsive to hepatoprotective therapy.
- Patients with severe infections, such as respiratory, biliary tract, or abdominal infections.
- Patients with severe underlying diseases, particularly immune-related disorders.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Maintenance group
This group consists of patients with initially unresectable hepatocellular carcinoma (HCC) who, after successful downstaging achieved through the combination therapy of Transarterial Chemoembolization (TACE), lenvatinib, and a PD-1 inhibitor, continued with the same non-surgical, maintenance treatment regimen instead of undergoing surgical resection.
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This intervention describes the non-surgical maintenance therapy for patients in the Maintenance Group after successful downstaging.
It consists of continuing the same doses of lenvatinib and PD-1 inhibitor that were administered during the downstaging phase, combined with on-demand TACE performed only upon imaging or biomarker evidence of intrahepatic progression.
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Liver Resection group
This group consists of patients with initially unresectable hepatocellular carcinoma (HCC) who, after achieving successful downstaging through the combination therapy of Transarterial Chemoembolization (TACE), lenvatinib, and a PD-1 inhibitor, underwent curative-intent surgical resection (R0 resection) as their subsequent treatment.
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This intervention consists of curative-intent surgical resection of hepatocellular carcinoma (HCC) performed after successful downstaging achieved through prior TACE combined with lenvatinib and PD-1 inhibitor therapy.
The procedure aims to remove all visible and radiologically responsive tumor tissue to achieve a pathologically confirmed R0 resection margin.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recurrence free survival
Periodo de tiempo: From date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months
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Time interval from date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months
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From date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Supervivencia global
Periodo de tiempo: Desde la fecha del tratamiento inicial hasta la fecha de muerte por cualquier causa, lo que ocurra primero, evaluado hasta 24 meses
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Intervalo de tiempo desde la fecha del tratamiento inicial hasta la fecha de muerte por cualquier causa, lo que ocurra primero, evaluado hasta 24 meses
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Desde la fecha del tratamiento inicial hasta la fecha de muerte por cualquier causa, lo que ocurra primero, evaluado hasta 24 meses
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Wenzhe Fan, Dr., First Affiliated Hospital, Sun Yat-Sen University
- Investigador principal: Shunjun Fu, Dr., Southern Medical University, China
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
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades del HIGADO
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Neoplasias Hepaticas
- Carcinoma
- Carcinoma Hepatocelular
- Procedimientos quirúrgicos, operativo
- Procedimientos quirúrgicos del sistema digestivo
- Hepatectomía
- lenvatinib
Otros números de identificación del estudio
- 2026-KY-180-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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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