Идёт набор NCT06622031

TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT

Без фазы С лечением Hepatocellular Carcinoma Portal Vein Tumor Thrombus Systemic Therapy

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: Transjugular intrahepatic portosystemic shunt, Lenvatinib, PD-1 inhibitor.
Кому может быть актуально: Состояния в реестре: Hepatocellular Carcinoma, Portal Vein Tumor Thrombus, Systemic Therapy. 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

Transjugular Intrahepatic Portosystemic Shunt Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus: 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, then the second is the tumor-caused death. It is vital to prevent the portal hypertension by PVTT.

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. In this study, the investigators explore the TIPS combined with Lenvatinib and PD-1 inhibitor for advanced hepatocellular carcinoma with main trunk portal vein tumor thrombus. The investigators aim to add clinical evidence for this subtype of advanced HCC.

Вмешательства

Процедура Transjugular intrahepatic portosystemic shunt
A needle punctured the portal vein through the transjugular approach. After a successful puncture, the parenchymal tract was dilated, and covered stents were introduced. The specifications of the covered stents were 8 mm × 50 mm, 8 mm × 60 mm, 8 mm × 70 mm, and 8 mm × 80 mm. All of the diameters of the bare stents were 8 mm, and the lengths were 50-80 mm. The portal vein pressure was measured before and after shunt creation. After the insertion of TIPS, all of the participants received a diureti
Препарат Lenvatinib
12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg
Препарат PD-1 inhibitor
Tislelizumab (200mg intravenously every 3 weeks), Sintilimab (200mg intravenously every 3 weeks), Camrelizumab (200mg intravenously every 3 weeks)

Первичные конечные точки

Rates of gastrointestinal hemorrhage [Срок оценки: 6 months]

Вторичные конечные точки (4)

Progression-Free-Survival (PFS) [Срок оценки: 12 months]
Overall survival (OS) [Срок оценки: 24 months]
Objective response rate (ORR) [Срок оценки: 6 months]
Adverse events [Срок оценки: 24 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;
with or without PVTT induced acute variceal bleeding;
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.