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NCT Number: NCT07356037

Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

West China School of Medicine/West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nanocrystalline Megestrol Acetate

Drug

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.

Standard Antitumor Therapy

Combination Product

Standard Antitumor Therapy

Primary outcomes

  1. 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 outcomes

  1. Proportion of patients with BMI increase

    Time frame: Proportion of patients with BMI increase in 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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