NCT07356037

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-10
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: China