ClinicalTrials.gg
Not yet recruitingNCT07356037Updated Jan 21, 2026

Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma

A Phase 3 interventional study of Nanocrystalline Megestrol Acetate and Standard Antitumor Therapy in Cachexia and Hepatocellular Carcinoma, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cachexia
  • Hepatocellular Carcinoma
03

In context

Cachexia

331 studies on the registry are indexed under Cachexia; 75 are open to participants now.

This study's planned enrollment of 68 is close to the median of 74 across 226 interventional studies indexed under Cachexia.

Browse Cachexia studies →

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 111 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. 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 v1.1.
  5. Meet the diagnostic criteria for pre-cachexia or cachexia (based on the Fearon criteria).

Exclusion 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 (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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

iRECIST and mRECIST

Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy

    Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy

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

  • Active comparator
    Standard Antitumor Therapy

    Standard Antitumor Therapy

    Combination Product: Standard Antitumor Therapy

Interventions

  • 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 productStandard Antitumor Therapy

    Standard Antitumor Therapy

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Proportion of patients with BMI increase

    Time frame: Proportion of patients with BMI increase in 12 weeks

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07356037
Responsible party
Sponsor
First posted
Jan 21, 2026
Start date
Jan 10, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jan 21, 2026

Study contacts

Chang Liu
Contact
drliuchang@wchscu.cn
+86 18180464347

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Megestrol Acetate

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