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Идёт набор NCT06644430

Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma

Наблюдательное Advanced Hepatocellular Carcinoma Lung Cancer Oligometastasis Ablation

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: Ablation, system therapy.
Кому может быть актуально
Состояния в реестре: Advanced Hepatocellular Carcinoma, Lung Cancer, Oligometastasis, Ablation. 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 →
Официальное название

Ablation of Pulmonary Oligometastasis Combined With System Compared System Therapy for Advanced Hepatocellular Carcinoma: a Multicenter Retrospective Study

Обзор

Ablation has been an effective therapy in treating intrathoracic metastases. However, for hepatocellular carcinoma with pulmonary oligometastasis, ablation of metastases remains relatively unexplored and still needs clinical evidence.

Подробное описание

Systemic therapy is the standard treatment for advanced hepatocellular carcinoma (HCC) with metastasis. However, metastases with limited number (oligometastasis) can represent a subtype and transition point between localized disease and widespread metastases. Thus, eliminating metastases could be advantageous and beneficial to the prognosis if feasible and permitted. Image-guided ablation therapy, such as microwave ablation (MWA), radiofrequency ablation (RFA), and cryoablation, has attracted great interest as a minimally invasive approach against intrathoracic metastases. Recently, ablation has been used on patients with pulmonary metastases from various cancers. This technique yields high proportions of sustained complete responses and is associated with relatively low morbidity. This multicenter study focuses on the management of ablation of oligometastasis therapy combined with systemic therapy.

Вмешательства

  • Процедура Ablation
    Ablation including (microwave ablation, radiofrequency ablation, cryoblation), this surgery was conducted under CT guidence. The pulmonary was completely ablated.
  • Препарат system therapy
    Paticipants received systemic therapy according the instructions.

Первичные конечные точки

  • Progression-Free-Survival [Срок оценки: 12 months]
Вторичные конечные точки (2)
  • Overall survival (OS) [Срок оценки: 24 months]
  • Objective response rate (ORR) [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 pulmonary oligometastasis, the metastases found within three month of HCC diagnosis;
  • metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm;
  • receipt of first-line systemic therapy for minimum of 3 months before ablation, with controlled intrahepatic tumors and no progression of metastases. Controlled intrahepatic tumors were defined as those showing a partial or stable response according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST);
  • undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) were included;
  • classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • no history of other malignancies.
  • life expectancy more than 3 months;
  • 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.

Критерии исключения

  • intermediate HCC;
  • age < 18 years or > 75 years;
  • advanced HCC with more than five metastases;
  • no response to Lenvatinib;
  • metastases size > 5 cm;
  • life expectancy less than 3 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: NCT06644430 · CHEST-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗