Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nanocrystalline Megestrol Acetate, Standard Antitumor Therapy.
- Who it may be relevant to
- Registry conditions: Cachexia, Hepatocellular Carcinoma. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Clinical Study of Nanocrystalline Megestrol Acetate in Combination With Standard Therapy Versus Standard Therapy Alone for Cachectic Stage Locally Advanced Hepatocellular Carcinoma
Overview
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.
Interventions
- Drug 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. - Combination product Standard Antitumor Therapy
Standard Antitumor Therapy
Primary outcome measures
- The proportion of subjects with improved appetite based on A/CS-12 assessment. [Time frame: The proportion of subjects with improved appetite based on A/CS-12 assessment in 12 weeks]
Secondary outcome measures (1)
- Proportion of patients with BMI increase [Time frame: Proportion of patients with BMI increase in 12 weeks]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China School of Medicine/West China Hospital of Sichuan University — Chengdu
Identifiers
NCT: NCT07356037 · EpiCure-HCC 01