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Набор скоро начнётся NCT07557914

Epalrestat Combined With HAIC, Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable HCC and Diabetes

Фаза II С лечением HCC - Hepatocellular Carcinoma Diabetes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Epalrestat, Donafenib + Tislelizumab, HAIC.
Кому может быть актуально
Состояния в реестре: HCC - Hepatocellular Carcinoma, Diabetes. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат Epalrestat
    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.
  • Препарат Donafenib + Tislelizumab
    donafenib 0.2g BID, tislelizumab 200mg/21days
  • Процедура HAIC
    Include FOLFOX and RALOX.

Первичные конечные точки

  • 12-month Event-free survival (EFS) Rate [Срок оценки: 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.]
Вторичные конечные точки (11)
  • Event-free survival (EFS) [Срок оценки: 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.]
  • Overall survival (OS) [Срок оценки: Up to approximately 2 years]
  • Progression free survival(PFS) (Overall) [Срок оценки: From enrollment to progressive disease (according to mRECIST) or death due to any cause, up to 2 years.]
  • Progression free survival(PFS) of intra-hepatic lesions [Срок оценки: From the enrollment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, up to 2 years.]
  • Progression free survival(PFS) of extra-hepatic lesions [Срок оценки: From the enrollment to the first documented appearance of extra-hepatic lesions or death due to any cause, up to 2 years.]
  • Objective response rate(ORR) per RESCIST 1.1 [Срок оценки: Up to approximately 2 years]
  • ORR per mRECIST [Срок оценки: Up to approximately 2 years]
  • PVTT response rate per mRECIST [Срок оценки: Up to approximately 2 years]
  • Disease control rate(DCR) per RESCIST 1.1 [Срок оценки: Up to approximately 2 years]
  • DCR per mRECIST [Срок оценки: Up to approximately 2 years]
  • Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0 [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

  • Diabetes mellitus combined with unresectable advanced HCC (BCLC stage C);
  • Patients who have the need for treatment, prevention and improvement of diabetic neuropathy;
  • Liver function at Child-Pugh grade A or B (≤ 7 points), ECOG PS 0-1;
  • Age 18-80 years old. Confirmed as unrectable HCC through pathological or imaging diagnosis;

Критерии исключения

  • Severe liver dysfunction: Child-Pugh C grade (≥ 8 points) or active hepatic encephalopathy Illness;
  • Extensive extrahepatic metastases (e.g., lung, bone, or peritoneum metastases);
  • Severe cardiovascular diseases: Uncontrolled heart failure, recent myocardial infarction;
  • Renal failure: Creatinine clearance rate < 30 mL/min;
  • Thrombocytopenia (less than 50×10⁹/L) or coagulation dysfunction (INR greater than 1.5);
  • Active infection (such as uncontrolled hepatitis B virus replication with HBV-DNA > 2000 IU/mL);
  • ECOG PS ≥ 2 or extremely poor overall condition;
  • Diabetic patients with acute ketoacidosis or during the period of severe infection;
  • Pregnant and lactating women;
  • Known history of other malignancy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The First Hospital of China Medical University — Шэньян

Идентификаторы

NCT: NCT07557914 · kelunshen【2025】2025-861-2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗