Anatomic Versus Nonanatomic Liver Resection After Conversion Therapy for Hepatocellular Carcinoma

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio

Observacional

Fase

No aplica / no indicada

Rango de edad

18 años - 75 años

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

874 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

This prospective observational cohort study will compare the survival outcomes of anatomic liver resection (ALR) versus nonanatomic liver resection (NALR) in patients with initially unresectable hepatocellular carcinoma (HCC) who become eligible for resection following immune checkpoint inhibitor (ICI)-based conversion therapy. Emerging evidence suggests that surgical resection may provide a survival benefit for selected patients with initially unresectable HCC after conversion therapy; however, the optimal surgical approach for these patients remains unclear. This study aims to inform surgical decision-making in this setting. Participants will be included in one of two cohorts according to the procedure received: ALR or NALR. The primary outcome is the 2-year recurrence-free survival (RFS) rate. Participants will undergo regular imaging assessments and survival follow-up. The target enrollment is 874 participants, with approximately 437 planned for each cohort; because treatment allocation is not randomized, the actual cohort sizes may differ.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

• Clinical diagnosis of initially unresectable HCC
• Received conversion therapy based on PD-1/PD-L1 therapy.
• Two liver surgeons with associate senior or higher professional titles determine that R0 resection is feasible after conversion therapy.
• Child-Pugh class A liver function.
• ECOG performance status 0 or 1.
• Adequate organ and bone marrow function, based on laboratory tests within 7 days before enrollment: ANC ≥1.5 × 10\^9/L; platelet count ≥75 × 10\^9/L; hemoglobin ≥9.0 g/dL; total bilirubin ≤1.5 × ULN; ALT, AST, and ALP ≤3 × ULN; serum albumin ≥28 g/L; serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min by Cockcroft-Gault; urine protein \<2+, or, if ≥2+ at baseline, 24-hour urine protein \<1 g; INR and APTT ≤1.5 × ULN; TSH between the lower and upper limits of normal (if abnormal, FT3 and FT4 must be normal).

Exclusion Criteria:

• Any cancer treatment other than conversion therapy.
• Any of the following within 12 months before study start: myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), or pulmonary embolism; ongoing arrhythmia of CTCAE Grade 2 or higher; or QTc \>450 ms in men or \>470 ms in women.
• Renal insufficiency requiring peritoneal dialysis or hemodialysis.
• Severe dysfunction of another major organ.
• Prior diagnosis of a second primary malignancy.
• Known or new evidence of brain or leptomeningeal disease.
• Hemophilia or bleeding tendency, or therapeutic anticoagulation with coumarin derivatives.
• Prior organ transplantation.

Población del estudio

Patients with initially unresectable HCC who underwent liver resection after successful immune checkpoint inhibitor-based conversion therapy conversion therapy at the Sun Yat-sen University Cancer Center (SYSUCC)

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No informado

Enmascaramiento

No informado

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Equipo y fechas

Patrocinador principal

Sun Yat-sen University

Inicio del estudio

25 oct 2026 Estimado

Finalización primaria

31 dic 2030 Estimado

Finalización del estudio

31 dic 2030 Estimado

Primera publicación

10 nov 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio