Идёт набор NCT06624098

Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma

Без фазы С лечением Advanced Hepatocellular Carcinoma Variceal Bleeding

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: Early TIPS.
Кому может быть актуально: Состояния в реестре: Advanced Hepatocellular Carcinoma, Variceal Bleeding. 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 →

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Официальное название

Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus Induced Gastrointestinal Bleeding: a Multicenter Phase II Study

Обзор

Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective.

Подробное описание

Portal hypertension by main trunk portal vein tumor thrombus (PVTT) is a severe disease. Patients usually die of gastrointestinal hemorrhage rather than tumor progression. It is vital to prevent the portal hypertension. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective method to alleviate the portal pressure. Then the risk of gastrointestinal hemorrhage is decreased which provides an opportunity for system therapy. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective for cirrhosis induced portal hypertension. However, the PVTT induced portal hypertension still needs clinical evidence. In this study, the investigators explore the early TIPS for advanced hepatocellular carcinoma with main trunk portal vein tumor thrombus induced acute variceal bleeding. The investigators aim to added clinical evidence for this subtype of advanced HCC.

Вмешательства

Процедура Early TIPS
TIPS was performed within 72 hours after the endoscopic hemostasis.

Первичные конечные точки

Rates of technical success [Срок оценки: 3 months]

Вторичные конечные точки (5)

Rates of gastrointestinal hemorrhage [Срок оценки: 6 months]
Progression-Free-Survival (PFS) [Срок оценки: 12 months]
Overall survival (OS) [Срок оценки: 12 months]
Objective response rate (ORR) [Срок оценки: 12 months]
Adverse events [Срок оценки: 12 months]

Критерии участия

Критерии включения

diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
presence of PVTT with III-IV grade by Cheng's criteria;
having PVTT induced portal hypertension;
TIPS was performed within 72 hours after the endoscopic hemostasis;
metastases with limited five sites and no more two organs involved;
number of Intrahepatic tumors were no more than five;
receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
no history of other malignancies;
agreed to participated in this clinical trial;
Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.