Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma

Официальное название

A Prospective Clinical Study of Nanocrystalline Megestrol Acetate in Combination With Standard Therapy Versus Standard Therapy Alone for Cachectic Stage Locally Advanced Hepatocellular Carcinoma

Обзор

This study is a prospective, randomized, parallel-controlled clinical trial. The primary objective is to evaluate the superiority and safety of nanocrystalline megestrol acetate in combination with standard therapy compared with standard therapy alone in improving appetite and body mass index (BMI) during treatment in patients with early-stage or locally advanced hepatocellular carcinoma at the cachexia stage.

Вмешательства

• Препарат Nanocrystalline Megestrol Acetate
  Nanocrystalline Megestrol Acetate oral suspension, with a specification of 125 mg/mL, administered orally at a dose of 5 mL per day (625 mg/day), and the primary endpoint efficacy collection will be conducted in the 4th week.
• Комбинированный продукт Standard Antitumor Therapy
  Standard Antitumor Therapy

Первичные конечные точки

• The proportion of subjects with improved appetite based on A/CS-12 assessment. [Срок оценки: The proportion of subjects with improved appetite based on A/CS-12 assessment in 12 weeks]

Вторичные конечные точки (1)

• Proportion of patients with BMI increase [Срок оценки: Proportion of patients with BMI increase in 12 weeks]

Критерии участия

Критерии включения

• Patients with hepatocellular carcinoma who have not previously received systemic therapy and are confirmed by histological or cytological assessment, as evaluated by the investigator, to be unsuitable or ineligible for curative surgical resection; Barcelona Clinic Liver Cancer (BCLC) stage B-C.
• Child-Pugh class A or B7.
• Planned to receive interventional therapy in combination with systemic antitumor therapy.
• At least one measurable tumor lesion according to mRECIST v1.1.
• Meet the diagnostic criteria for pre-cachexia or cachexia (based on the Fearon criteria).

Критерии исключения

• Presence of any condition affecting gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrolled vomiting; patients receiving tube feeding or parenteral nutrition.
• Presence of anorexia due to anorexia nervosa, psychiatric disorders, or pain that makes eating difficult.
• Patients with acquired immunodeficiency syndrome (AIDS).
• Currently receiving or planning to receive other medications that increase appetite or body weight, such as corticosteroids (except short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.
• Patients with Cushing's syndrome, adrenal or pituitary insufficiency, or poorly controlled diabetes mellitus.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• West China School of Medicine/West China Hospital of Sichuan University — Чэнду

Идентификаторы

NCT: NCT07356037 · EpiCure-HCC 01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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