Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma

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: Hepatocellular Carcinoma; Cachexia
• Intervention / Treatment: Drug: Nanocrystalline Megestrol Acetate; Combination product: Standard Antitumor Therapy

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chang Liu; Phone Number: +86 18180464347; Email: drliuchang@wchscu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • West China School of Medicine/West China Hospital of Sichuan University
      • Contact: Chang Liu; Phone Number: +86 18180464347; Email: drliuchang@wchscu.cn

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	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	Proportion of patients with BMI increase in 12 weeks

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Study record dates

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: Neoplasms by Site; Neoplasms; Body Weight; Body Weight Changes; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Weight Loss; Thinness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Carcinoma, Hepatocellular; Cachexia
• 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