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Radiomics Subtyping to Guide Surgery vs. Maintenance Therapy After HCC Downstaging

12 de mayo de 2026 actualizado por: Wenzhe Fan, First Affiliated Hospital, Sun Yat-Sen University

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

Tipo de estudio

De observación

Inscripción (Estimado)

500

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.

Ubicaciones de estudio

    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510280
        • ZhuJiang Hospital of Southern Medical University
      • Guangzhou, Guangdong, Porcelana, 510080
        • The First Affiiated Hospital of Sun Yat-sen University

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

Método de muestreo

Muestra no probabilística

Población de estudio

Patients with initially unresectable hepatocellular carcinoma who were treated with a combination therapy of TACE, lenvatinib, and a PD-1 inhibitor and subsequently achieved successful tumor downstaging.

Descripción

Inclusion Criteria:

  1. Patients diagnosed with hepatocellular carcinoma (HCC) based on clinical or pathological criteria;
  2. 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;
  3. 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;
  4. Liver function classified as Child-Pugh Class A or B, or achieved this standard after medical treatment;
  5. Performance status (PS) score of 0 or 1.

Exclusion Criteria:

  1. Patients with unclear diagnoses or those with concurrent other malignancies.
  2. For patients in the downstaging surgery group: Those who underwent non-R0 resection or received additional anti-tumor therapies postoperatively.
  3. For patients in the maintenance treatment group: Those who received anti-tumor therapies other than TACE/lenvatinib/PD-1 inhibitors.
  4. Liver function classified as Child-Pugh Class C or above, unresponsive to hepatoprotective therapy.
  5. Patients with severe infections, such as respiratory, biliary tract, or abdominal infections.
  6. Patients with severe underlying diseases, particularly immune-related disorders.

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
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.
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
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
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
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
Desde la fecha del tratamiento inicial hasta la fecha de muerte por cualquier causa, lo que ocurra primero, evaluado hasta 24 meses

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

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 (Actual)

1 de enero de 2018

Finalización primaria (Estimado)

31 de diciembre de 2026

Finalización del estudio (Estimado)

31 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

6 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2026

Publicado por primera vez (Actual)

12 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

The dataset contains detailed and potentially re-identifiable patient information, including medical images, clinical records, and treatment outcomes. Due to institutional data privacy policies, ethical restrictions related to patient confidentiality, and the lack of broad consent from participants for data sharing beyond the scope of this specific research, the investigators are unable to publicly share individual participant data (IPD). All data will be stored securely within the hospital's internal research database, and access will be restricted to the study investigators for analysis purposes only. Requests for aggregated or de-identified results may be considered upon reasonable inquiry to the corresponding author, subject to institutional review and compliance with applicable regulations.

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. .

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