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Идёт набор NCT06641713

HAIC Compared With TACE in Huge Hepatocellular Carcinoma

— Наблюдательное Hepatocellular Carcinoma Hepatic Chemotherapy Liver Cancer

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, HAIC.
Кому может быть актуально
Состояния в реестре: Hepatocellular Carcinoma, Hepatic Chemotherapy, Liver Cancer. 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
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Официальное название

Hepatic Arterial Infusion Chemotherapy Compared With Transcatheter Arterial Chemoembolizationin Intermediate-advanced Huge Hepatocellular Carcinoma: a Multicenter Retrospective Study

Обзор

This study intends to compare the efficacy of transcatheter arterial chemical embolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) for patients with intermediate-advanced huge hepatocellular carcinoma.

Подробное описание

Transcatheter arterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) are effective and safe for hepatocellular carcinoma (HCC). For huge HCC (≥10 cm), the prognosis of this high tumor-burden subtype usually indicates poor outcome and big challenge. TACE is difficult to completely embolize all tumor arteries, so patients have limited benefit from pure hepatic artery embolization. At the same time, excessive embolization will lead to massive tumor necrosis in a short time, and inflammatory necrosis factor will enter the blood, resulting in systemic inflammatory response. HAIC have showed good efficacy especially for advanced huge HCC (≥10 cm) complicated with portal vein tumor thrombus and arteriovenous fistula, and HAIC therapy can be performed with better and higher tumor control.

Вмешательства

  • Процедура TACE
    TACE was carried out under the guidance of digital subtraction angiography, and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The emulsion of the selected drug and the embolization agents was therefore injected infused into tumor-feeding arteries via the selective microcatheter. A final arteriography confirmed the success of the procedure. The endpoint of the
  • Процедура HAIC
    HAIC was carried out under the guidance of digital subtraction angiography, 990and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1, and 400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day

Первичные конечные точки

  • Objective response rate [Срок оценки: 6 months]
Вторичные конечные точки (2)
  • Progression-Free-Survival [Срок оценки: 12 months]
  • Overall survival [Срок оценки: 24 months]

Критерии участия

Критерии включения

  • Clinical diagnosis of primary HCC.
  • Age between 18 and 75 years;
  • The maximum tumor size ≥10 cm;
  • Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
  • limited metastases (≤5).
  • Child-Pugh class A or B;
  • Eastern Cooperative Group performance status (ECOG) score of 0-1;
  • Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
  • Prothrombin time ≤18s or international normalized ratio < 1.7.

Критерии исключения

  • recurrent HCC;
  • Extrahepatic metastasis >5;
  • Obstructive PVTT involving mesenteric vena cava (PVTT IV).
  • Serious medical comorbidities.
  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
  • Eastern Cooperative Group performance status (ECOG) score of ≥2;
  • Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Chinese PLA general hospital — Пекин

Идентификаторы

NCT: NCT06641713 · Liver Projiect 13

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗