Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma

Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Study ID
NCT07356037
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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.
  • Standard Antitumor Therapy — COMBINATION_PRODUCT
    Standard Antitumor Therapy

Study Details

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.

Key Dates

First listed
Jan 21, 2026
Start date
Jan 10, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy
    Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy
  • Active Comparator: Standard Antitumor Therapy
    Standard Antitumor Therapy

Primary Outcome Measure

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 ]

Central Contacts

Find similar trials

Nationwide
Liver cancer trialsOncology trialsGI oncology trialsHepatology trials

Related Studies