Меню
Идёт набор NCT06898398

TACE Combined Surgery for the Resectable Huge HCC

— Наблюдательное Hepatocellular Carcinoma Hepatic Chemotherapy Liver Cancer Surgery

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: TACE, Surgery.
Кому может быть актуально
Состояния в реестре: Hepatocellular Carcinoma, Hepatic Chemotherapy, Liver Cancer, Surgery. Базовые параметры: 18 лет — 75 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Transcatheter Arterial Chemoembolization Combined Surgery Versus Surgery for the Resectable Huge Hepatocellular Carcinoma: a Multicenter Propensity Analysis

Обзор

Huge hepatocellular carcinoma (HCC) is defined as a tumor with a maximum diameter greater than 10 cm. With advancements in surgical techniques, hepatectomy can be performed safely in some patients with huge HCC without vascular invasion or distant metastasis and with preserved liver function. The high risk of recurrence after surgery is another challenge for surgeons. Neoadjuvant TACE has been shown to improve the clinical outcomes of patients with HCC, especially those with a high risk of recurrence, such as those with multinodular tumors, large tumors, and tumor thrombus. The present multicenter study aimed to evaluate the efficacy of neoadjuvant TACE in patients with huge HCC who underwent liver resection.

Подробное описание

Huge hepatocellular carcinoma (HCC) is defined as a tumor with a maximum diameter greater than 10 cm. With advancements in surgical techniques, hepatectomy can be performed safely in some patients with huge HCC without vascular invasion or distant metastasis and with preserved liver function. However, the 2-year recurrence rate in such cases is as high as 70%, indicating the need for more effective interventions to improve outcomes. Neoadjuvant TACE has been shown to improve the clinical outcomes of patients with HCC, especially those with a high risk of recurrence, such as those with multinodular tumors, large tumors, and tumor thrombus. The impact of neoadjuvant TACE on the long-term oncological outcomes of huge HCC requires investigation. The present multicenter study aimed to evaluate the efficacy of neoadjuvant TACE in patients with huge HCC who underwent liver resection.

Вмешательства

  • Процедура TACE
    TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.
  • Процедура Surgery
    The surgical plan was based on the tumor size, tumor location, and liver function. We applied Pringle's maneuver with cycles of clamping and unclamping times of 1-10 and 5 min, respectively, and maintained the central venous pressure below 4 mmHg during parenchymal dissection to control intraoperative bleeding.

Первичные конечные точки

  • Recurrence-free survival （RFS） [Срок оценки: 24 months]
Вторичные конечные точки (1)
  • Overall survival (OS) [Срок оценки: 60 months]

Критерии участия

Критерии включения

  • clinical or pathological diagnosis of primary HCC;
  • tumor diameter > 10 cm on images before inclusion;
  • age 18 to 75 years;
  • no macrovascular invasion or extrahepatic metastasis;
  • liver resection with complete removal of the tumor and adequate remnant liver volume;
  • albumin-bilirubin (ALBI) grade I and II;
  • Eastern Cooperative Oncology Group performance status (ECOG) score of 0-1;
  • hemoglobin level ≥ 8.5 g/dL, total bilirubin level ≤ 30 mmol/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) levels ≤ 5 × upper limit of normal, serum creatinine level ≤ 1.5 × upper limit of normal;
  • prothrombin time ≤ 18 s or international normalized ratio < 1.7.

Критерии исключения

  • HCC with macrovascular invasion or extrahepatic metastasis;
  • tumor with a maximum diameter ≤ 10 cm on images before inclusion;
  • recurrent HCC;
  • serious medical comorbidities;
  • portal hypertension, including presence of either esophageal varices or splenomegaly with a platelet count less than 109/L;
  • cardiac ventricular arrhythmias requiring anti-arrhythmic therapy;
  • incomplete data or lost to follow-up within three months.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Chinese PLA general hospital — Пекин

Идентификаторы

NCT: NCT06898398 · Liver Project 15

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗