Epalrestat Combined With HAIC, Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable HCC and Diabetes
HCC - Hepatocellular Carcinoma · Diabetes
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 2
- Rango de edad
- 18 años - 80 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 32 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
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Acerca de la investigación
The purpose of this study is to evaluate the comprehensive therapeutic efficacy and safety profile of the epalrestat combined with hepatic artery infusion chemotherapy (HAIC), donafenib and tislelizumab quadruple regimen in patients with unresectable hepatocellular carcinoma (HCC) and diabetes.
¿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:
1. Diabetes mellitus combined with unresectable advanced HCC (BCLC stage C);
2. Patients who have the need for treatment, prevention and improvement of diabetic neuropathy;
3. Liver function at Child-Pugh grade A or B (≤ 7 points), ECOG PS 0-1;
4. Age 18-80 years old. Confirmed as unrectable HCC through pathological or imaging diagnosis;
Exclusion Criteria:
1. Severe liver dysfunction: Child-Pugh C grade (≥ 8 points) or active hepatic encephalopathy Illness;
2. Extensive extrahepatic metastases (e.g., lung, bone, or peritoneum metastases);
3. Severe cardiovascular diseases: Uncontrolled heart failure, recent myocardial infarction;
4. Renal failure: Creatinine clearance rate \< 30 mL/min;
5. Thrombocytopenia (less than 50×10⁹/L) or coagulation dysfunction (INR greater than 1.5);
6. Active infection (such as uncontrolled hepatitis B virus replication with HBV-DNA \> 2000 IU/mL);
7. ECOG PS ≥ 2 or extremely poor overall condition;
8. Diabetic patients with acute ketoacidosis or during the period of severe infection;
9. Pregnant and lactating women;
10. Known history of other malignancy.
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 aplica
- Enmascaramiento
- Sin enmascaramiento
Epalrestat plus HAIC, donafenib and tislelizumab
Epalrestat 50mg tid, donafenib 0.2g bid, tislelizumab 200mg per 21days, HAIC (FOLFOX or RALOX) per 21days
Drug: Epalrestat · Drug: Donafenib + Tislelizumab · Procedure: HAIC
Epalrestat DRUG
For the first 6 patients in the safety lead-in period, the starting dose of epalrestat was 50 mg, three times per day. If dose-limiting toxicity (DLT) occurred in the first 6 patients, the dose for the second round of 6 patients in the safety lead-in period would be adjusted to 50 mg, twice per day. If DLT occurred in the second round of 6 patients, the dose for the third round of 6 patients in the safety lead-in period would be adjusted to 50 mg, once per day.
Donafenib + Tislelizumab DRUG
donafenib 0.2g BID, tislelizumab 200mg/21days
HAIC PROCEDURE
Include FOLFOX and RALOX.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
12-month Event-free survival (EFS) Rate
Plazo: From treatment to the first occurrence of a predefined event (progression of disease, death for any reason, terminate the treatment due to intolerable AEs), assessed up to 2 years.
The proportion of patients who have remained event-free from the start of treatment until the 12-month time point.(Predefined events include: progression of disease, death for any reason, terminate the treatment due to intolerable AEs.)
Medidas secundarias
Event-free survival (EFS)
Plazo: From treatment to the first occurrence of a predefined event (progression of disease, death for any reason, terminate the treatment due to intolerable AEs), assessed up to 2 years.
Defined as the time from treatment to the first occurrence of a predefined event (progression of disease, death for any reason, terminate the treatment due to intolerable AEs).
Overall survival (OS)
Plazo: Up to approximately 2 years
The OS is defined as the time from the enrollment to death due to any cause.
Progression free survival(PFS) (Overall)
Plazo: From enrollment to progressive disease (according to mRECIST) or death due to any cause, up to 2 years.
The PFS is defined as the time from the enrollment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.
Progression free survival(PFS) of intra-hepatic lesions
Plazo: From the enrollment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, up to 2 years.
The PFS is defined as the time from the enrollment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, whichever occurs first.
Progression free survival(PFS) of extra-hepatic lesions
Plazo: From the enrollment to the first documented appearance of extra-hepatic lesions or death due to any cause, up to 2 years.
The PFS is defined as the time from the enrollment to the first documented appearance of extra-hepatic lesions or death due to any cause, whichever occurs first.
Objective response rate(ORR) per RESCIST 1.1
Plazo: Up to approximately 2 years
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
ORR per mRECIST
Plazo: Up to approximately 2 years
The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.
PVTT response rate per mRECIST
Plazo: Up to approximately 2 years
The PVTT response rate is defined as the proportion of patients with a documented CR or PR of PVTT.
According to the Vp classification:
CR: PVTT disappears or the portal vein becomes completely unobstructed. PR: Decrease in VP classification. SD: Without PR and PD. PD: Increase in VP classification.
Disease control rate(DCR) per RESCIST 1.1
Plazo: Up to approximately 2 years
The DCR is defined as the proportion of patients with a documented complete response(CR), partial response(PR) or stable disease(SD) per RECIST 1.1.
DCR per mRECIST
Plazo: Up to approximately 2 years
The DCR is defined as the proportion of patients with a documented complete response(CR), partial response(PR) or stable disease(SD) per mRECIST.
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
Plazo: Up to approximately 2 years
The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (4)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
4 centros
Harbin Medical University Cancer HospitalHarbin, Heilongjiang, ChinaAún no recluta
Yanbian University HospitalYanji, Jilin, ChinaReclutando
The First Hospital of China Medical UniversityShenyang, Liaoning, ChinaActivo, sin reclutamiento
Liaoning Cancer HospitalShenyang, Liaoning, ChinaAún no recluta
Equipo y fechas
- Patrocinador principal
- Haibo Shao
- Inicio del estudio
- 21 ene 2026 Real
- Finalización primaria
- 2029-12 Estimado
- Finalización del estudio
- 2030-12 Estimado
- Primera publicación
- 30 abr 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Multicenter, Prospective, Single-arm Clinical Study Evaluating the Efficacy and Safety of Epalrestat Combined With Hepatic Arterial Chemotherapy Infusion (HAIC), Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable Hepatocellular Carcinoma and Diabetes
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026