Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma

Starting soon · Phase 3

Conditions studied: Cachexia, Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT07356037

Run by

Changchun GeneScience Pharmaceutical Co., Ltd.

People needed

68

Starts

2026-01-10

Expected to finish

2027-12-31

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• West China School of Medicine/West China Hospital of Sichuan University — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

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