CachexiaPhase 3NCT07356037
Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma
A Phase 3 study testing Nanocrystalline Megestrol Acetate and Standard Antitumor Therapy in people with Cachexia and Hepatocellular Carcinoma, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cachexia, Hepatocellular Carcinoma
- What is being tested?
- Nanocrystalline Megestrol Acetate and Standard Antitumor Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2026to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
Chang Liu, +86 18180464347, drliuchang@wchscu.cn
About this study
Official title: 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.
- Conditions
- Cachexia, Hepatocellular Carcinoma
- Being tested
- Nanocrystalline Megestrol Acetate, Standard Antitumor Therapy
- Medical subject headings
- Cachexia, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanocrystalline Megestrol AcetateDrug
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 TherapyCombination product
Standard Antitumor Therapy
| Study group | Role | What they receive |
|---|---|---|
| Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy | Experimental | Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy Receives: Drug: Nanocrystalline Megestrol Acetate; Combination Product: Standard Antitumor Therapy |
| Standard Antitumor Therapy | Active comparator | Standard Antitumor Therapy Receives: Combination Product: Standard Antitumor Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with improved appetite based on A/CS-12 assessment.
Measured: 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
Measured: Proportion of patients with BMI increase in 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356037
- Sponsor's protocol ID
- EpiCure-HCC 01
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dai R, Lu F, Leng W, He Q, Guo W, Hai T, Liu C. NMA plus antitumor therapy versus antitumor therapy alone in patients with BCLC stage B or C hepatocellular carcinoma and pre-cachexia or cachexia: protocol for a prospective, multicenter, randomized, open-label phase II trial. Front Gastroenterol (Lausanne). 2026 Sep 29;5:1926294. doi: 10.3389/fgstr.2026.1926294. eCollection 2026.
PubMed 42871009
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of Nanocrystalline Megestrol Acetate in Combination With Standard Therapy Versus Standard Therapy Alone for Cachectic Stage Locally Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07356037
- Acronym / sponsor ID
- EpiCure-HCC 01
- Conditions
- Cachexia, Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy | Experimental | Drug: Nanocrystalline Megestrol Acetate, Combination Product: Standard Antitumor TherapyNanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy |
| Standard Antitumor Therapy | Active comparator | Combination Product: Standard Antitumor TherapyStandard Antitumor Therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanocrystalline Megestrol AcetateNanocrystalline 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. | Drug | Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy |
| Standard Antitumor TherapyStandard Antitumor Therapy | Combination product | Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy, Standard Antitumor Therapy |
Primary outcome
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
1 secondary outcome
Proportion of patients with BMI increase
Time frame: Proportion of patients with BMI increase in 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 42871009Dai R, Lu F, Leng W, He Q, Guo W, Hai T, Liu C. NMA plus antitumor therapy versus antitumor therapy alone in patients with BCLC stage B or C hepatocellular carcinoma and pre-cachexia or cachexia: protocol for a prospective, multicenter, randomized, open-label phase II trial. Front Gastroenterol (Lausanne). 2026 Sep 29;5:1926294. doi: 10.3389/fgstr.2026.1926294. eCollection 2026.
Related trials for Cachexia
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Not yet recruiting
Gut-Liver-Muscle Axis in Cancer Cachexia
Head & Neck Cancer
Not yet recruiting
Neuromuscular Electrical Stimulation to Improve the Muscle Health of Individuals With Acute Kidney Injury
Acute Kidney Injury, Acute Kidney Injury KDIGO 2
RecruitingPhase 2
Safety and Efficacy of KER-065 in Participants With Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nanocrystalline Megestrol Acetate and Standard Antitumor Therapy in people with Cachexia and Hepatocellular Carcinoma, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chang Liu (+86 18180464347, drliuchang@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07356037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.