PEARL Trial: Partial TACE Enhancing Anti-tumor Response With Lenvatinib in Unresectable HCC (Pearl)
14 de septiembre de 2026 actualizado por: Chang Gung Memorial Hospital
This is a single-arm, open-label, phase II clinical trial.
Patients with unresectable hepatocellular carcinoma (HCC) who are eligible for lenvatinib treatment will receive partial transarterial chemoembolization (TACE) targeting up to two liver segments containing the largest tumor volume or lesions at risk of rupture, in combination with standard lenvatinib therapy.
The partial TACE approach is designed as a liver-function-sparing technique that limits ischemic territory while preserving hepatic reserve.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Primary objective:
-1-year progression-free survival (PFS) by mRECIST
Secondary objectives:
- 1-year overall survival (OS)
- Objective response rate (ORR) and disease control rate (DCR) per RECIST v1.1 and mRECIST
- Incidence of hepatic decompensation within 30 days after treatment (defined as: bilirubin > 3 mg/dL, new or worsened ascites, or hepatic encephalopathy)
- Duration of response (DOR)
Exploratory Endpoints:
- Depth of response (DpR)
- Immune profile changes from baseline (assessed by multiparametric flow cytometry and single-cell RNA sequencing)
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- Fase 2
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.
Estudio Contacto
- Nombre: PO-Ting-Lin
- Número de teléfono: 886975362702
- Correo electrónico: linpoting0101@gmail.com
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
Descripción
Inclusion Criteria:
Diagnosis of HCC confirmed by histology/cytology or typical imaging features, unsuitable for surgical resection or liver transplantation
- Age ≥ 20 years at the time of signing informed consent
- ECOG performance status 0-1
- BCLC stage B or C (without main portal vein thrombosis)
- Child-Pugh score 5-7 (Class A or B7) within 28 days of registration
- Adequate bone marrow, liver, and renal function
- Blood pressure adequately controlled
- Ability to understand and sign written informed consent
Exclusion Criteria:
Prior systemic therapy for HCC
- Main portal vein thrombosis
- Prior locoregional therapy within 4 weeks
- Uncontrolled hypertension
- Clinically significant cardiovascular disease within 6 months
- Pregnancy or breastfeeding
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
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Partial TACE Enhancing Anti-tumor Response with Lenvatinib in unresectable HCC
Lenvatinib: Oral administration at 12 mg once daily (body weight ≥ 60 kg) or 8 mg once daily (body weight < 60 kg). Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal. Partial TACE: Performed within 4 weeks after starting lenvatinib. |
Oral lenvatinib 12 mg once daily for body weight 60 kg or greater, or 8 mg once daily for body weight less than 60 kg.
Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.
Transarterial chemoembolization targeting up to two liver segments containing the largest tumor volume or lesions at risk of rupture, performed within 4 weeks after starting lenvatinib.
This liver-function-sparing approach limits the ischemic territory in order to preserve hepatic reserve.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
1-year progression-free survival (PFS) by mRECIST
Periodo de tiempo: 1 year after start of study treatment
|
Percentage of participants alive and free of disease progression at 1 year.
Progression-free survival is measured from the start date of study treatment to the date of first documented disease progression according to modified RECIST (mRECIST) or death from any cause, whichever occurs first.
|
1 year after start of study treatment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
1-year overall survival (OS)
Periodo de tiempo: 1 year after start of study treatment
|
Percentage of participants alive at 1 year.
Overall survival is measured from the start date of study treatment to the date of death from any cause.
|
1 year after start of study treatment
|
|
Objective response rate (ORR) by mRECIST
Periodo de tiempo: Up to 12 months after start of study treatment
|
Percentage of participants with a best overall response of confirmed complete response or partial response, as assessed by modified RECIST (mRECIST).
Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment; a first objective response is confirmed by a second imaging assessment 4 weeks later.
|
Up to 12 months after start of study treatment
|
|
Objective response rate (ORR) by RECIST v1.1
Periodo de tiempo: Up to 12 months after start of study treatment
|
Percentage of participants with a best overall response of confirmed complete response or partial response, as assessed by RECIST version 1.1.
Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment; a first objective response is confirmed by a second imaging assessment 4 weeks later.
|
Up to 12 months after start of study treatment
|
|
Disease control rate (DCR) by mRECIST
Periodo de tiempo: Up to 12 months after start of study treatment
|
Percentage of participants with a best overall response of confirmed complete response, partial response, or stable disease, as assessed by modified RECIST (mRECIST).
Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment.
|
Up to 12 months after start of study treatment
|
|
Disease control rate (DCR) by RECIST v1.1
Periodo de tiempo: Up to 12 months after start of study treatment
|
Percentage of participants with a best overall response of confirmed complete response, partial response, or stable disease, as assessed by RECIST version 1.1.
Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment.
|
Up to 12 months after start of study treatment
|
|
Duration of response (DOR) by mRECIST
Periodo de tiempo: Up to 12 months after start of study treatment
|
Time from the date of first documented objective response (complete or partial response) to the date of first documented disease progression, as assessed by modified RECIST (mRECIST).
Reported in months.
|
Up to 12 months after start of study treatment
|
|
Incidence of hepatic decompensation
Periodo de tiempo: Within 30 days after treatment
|
Percentage of participants with hepatic decompensation within 30 days after treatment.
Hepatic decompensation is defined as any of the following: total bilirubin greater than 3 mg/dL, new or worsened ascites, or hepatic encephalopathy.
|
Within 30 days after treatment
|
|
Incidence of treatment-emergent adverse events
Periodo de tiempo: From first dose of study treatment up to 30 days after the last dose
|
Number of participants with treatment-emergent adverse events and serious adverse events, graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
From first dose of study treatment up to 30 days after the last dose
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Depth of response (maximum percentage reduction from baseline in the sum of viable target lesion diameters)
Periodo de tiempo: Up to 12 months after start of study treatment
|
Maximum percentage reduction from baseline in the sum of viable target lesion diameters, as assessed by modified RECIST (mRECIST).
Reported as percentage change from baseline.
|
Up to 12 months after start of study treatment
|
|
Change from baseline in immune cell subset frequencies assessed by multiparametric flow cytometry
Periodo de tiempo: Baseline, within 24 hours before TACE, within 48 hours after TACE, Week 12, and Week 24
|
Change from baseline in the frequencies of peripheral blood immune cell subsets measured by multiparametric flow cytometry, including CD4+ and CD8+ T cells, regulatory T cells, natural killer cells, mucosal-associated invariant T cells, and myeloid populations, together with the activation and exhaustion markers PD-1, TIM-3, HLA-DR, and CD38.
Reported as percentage of live cells.
|
Baseline, within 24 hours before TACE, within 48 hours after TACE, Week 12, and Week 24
|
|
Change from baseline in immune cell composition assessed by single-cell RNA sequencing
Periodo de tiempo: Baseline, within 24 hours before TACE, within 48 hours after TACE, Week 12, and Week 24
|
Change from baseline in immune cell composition measured by single-cell RNA sequencing of peripheral blood mononuclear cells and tissue samples, reported as percentage of sequenced cells assigned to each annotated immune cell cluster.
|
Baseline, within 24 hours before TACE, within 48 hours after TACE, Week 12, and Week 24
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
30 de septiembre de 2026
Finalización primaria (Estimado)
31 de mayo de 2029
Finalización del estudio (Estimado)
31 de mayo de 2029
Fechas de registro del estudio
Enviado por primera vez
25 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Publicado por primera vez (Actual)
18 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202600872A3
- LHYY001 (Otro número de subvención/financiamiento: Lin Huang Yueh-Ying Medical Foundation)
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
producto fabricado y exportado desde los 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. .