Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma

NCT07356037 | Not Yet Recruiting Phase 3

• 1 other identifier: EpiCure-HCC 01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cachexia; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of patients with BMI increase

  Proportion of patients with BMI increase in 12 weeks

Study Arms (2)

Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy

EXPERIMENTAL

Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy

Drug: Nanocrystalline Megestrol Acetate; Combination Product: Standard Antitumor Therapy

Standard Antitumor Therapy

ACTIVE COMPARATOR

Standard Antitumor Therapy

Combination Product: Standard Antitumor Therapy

Interventions

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.

Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy

Standard Antitumor Therapy COMBINATION_PRODUCT

Standard Antitumor Therapy

Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy; Standard Antitumor Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

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

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Cachexia; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Chang Liu

CONTACT

+86 18180464347; drliuchang@wchscu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 21, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (1)