Набор скоро начнётся NCT07368023

A Retrospective Study of Safety and Efficacy of Locoregional Therapies Combined With Anti-VEGF/TKIs and Immune Checkpoint Inhibitors for All Comers of Intention-to-treat Patients With Unresectable Hepatocellular Carcinoma

— Наблюдательное Hepatocellular Carcinoma Hepatocellular Carcinoma Non-resectable

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: Locoregional Therapy (LRT) + Systemic Drug Therapy.
Кому может быть актуально: Состояния в реестре: Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable. Базовые параметры: от 16 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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Обзор

This is a single-center, retrospective cohort study aiming to evaluate the safety and efficacy of a combined conversion therapy strategy for patients with initially unresectable hepatocellular carcinoma (HCC).The primary objective is to assess the outcomes of intention-to-treat (ITT) patients who received multidisciplinary conversion therapy. This therapy combines locoregional treatments (LRT, such as TACE or radiotherapy) with systemic therapy (anti-VEGF/tyrosine kinase inhibitors and immune checkpoint inhibitors) with the goal of down-staging tumors to allow for subsequent curative resection. The study plans to enroll 300 subjects. The exposure group will include approximately 100 patients with initially unresectable HCC who received the combined conversion therapy between January 2018 and December 2024. A control group of about 200 patients with initially resectable HCC who underwent direct radical surgery during the same period will be used for comparison. Data will be collected retrospectively from hospital electronic medical records and the HCC clinical database, with follow-up until December 2025.

Вмешательства

Комбинированный продукт Locoregional Therapy (LRT) + Systemic Drug Therapy
Treatment regimens, doses, and durations varied based on individual clinical decisions and are collected retrospectively.

Первичные конечные точки

Conversion Rate [Срок оценки: From the start of conversion therapy until the completion of therapy (assessed up to 24 months).]
1-, 2-, and 3-year OS in ITT Population [Срок оценки: Starting from conversion therapy, evaluate at 1, 2, and 3 years.]
Resection Rate After Conversion [Срок оценки: From the start of conversion therapy to the day of surgery (with a maximum evaluation period of 24 months).]

Критерии участия

Критерии включения

Aged 16 years or older.
Clinical and/or pathological diagnosis of hepatocellular carcinoma (HCC). China Liver Cancer (CNLC) stage I, II, or IIIA.
Assessed by a multidisciplinary team (MDT) as having initially unresectable HCC.