Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma

January 14, 2026 updated by: Changchun GeneScience Pharmaceutical Co., Ltd.

A Prospective Clinical Study of Nanocrystalline Megestrol Acetate in Combination With Standard Therapy Versus Standard Therapy Alone 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • West China School of Medicine/West China Hospital of Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Child-Pugh class A or B7.
  3. Planned to receive interventional therapy in combination with systemic antitumor therapy.
  4. At least one measurable tumor lesion according to mRECIST v1.1.
  5. Meet the diagnostic criteria for pre-cachexia or cachexia (based on the Fearon criteria).

Exclusion Criteria:

  1. Presence of any condition affecting gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrolled vomiting; patients receiving tube feeding or parenteral nutrition.
  2. Presence of anorexia due to anorexia nervosa, psychiatric disorders, or pain that makes eating difficult.
  3. Patients with acquired immunodeficiency syndrome (AIDS).
  4. 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.
  5. Patients with Cushing's syndrome, adrenal or pituitary insufficiency, or poorly controlled diabetes mellitus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy
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
Active Comparator: Standard Antitumor Therapy
Combination product: Standard Antitumor Therapy
Standard Antitumor Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
The proportion of subjects with improved appetite based on A/CS-12 assessment in 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with BMI increase
Time Frame: Proportion of patients with BMI increase in 12 weeks
Proportion of patients with BMI increase in 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 10, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 4, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EpiCure-HCC 01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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