Hepatocellular Carcinoma (HCC)Phase 2NCT07565415
Nanocrystalline Megestrol Acetate Versus Placebo for Anorexia in Patients With Unresectable Hepatocellular Carcinoma Receiving TACE Combined With Targeted and Immunotherapy
A Phase 2 study testing Nanocrystalline megestrol acetate in people with Hepatocellular Carcinoma (HCC) and Cachexia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Primary Objective: To evaluate the effect of nanocrystalline megestrol acetate versus placebo on body weight and appetite in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.Secondary Objectives: To evaluate the effect of nanocrystalline megestrol acetate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Cachexia, Anorexia
- What is being tested?
- Nanocrystalline megestrol acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2026to 1 Sep 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unresectable primary hepatocellular carcinoma (HCC) confirmed by imaging or histopathology
- No previous receipt of immunotherapy and/or targeted drug therapy
- Child-Pugh score ≤ 7
- At least one measurable lesion per RECIST 1.1 criteria; lesions without prior radiotherapy, cryotherapy or other local treatment
- Single intrahepatic lesion < 10 cm, or fewer than 10 intrahepatic lesions with tumor burden < 50%
- Meet precachexia criteria: non-volitional weight loss ≤ 5% in 6 months, plus systemic inflammation (CRP > 5 mg/L) or decreased appetite (FAACT-A/CS-12 score ≤ 37 points)
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- Meet cachexia criteria: accompanied by decreased appetite or systemic inflammation, with either non-volitional weight loss > 5% in 6 months or BMI < 18.5 kg/m² plus weight loss > 2%
- Voluntarily participate and sign informed consent
- Age ≥ 18 years, male or female
- Able to swallow tablets normally
- ECOG performance status 0 or 1
- Life expectancy ≥ 12 weeks
- Adequate major organ function without blood products or colony-stimulating factors within 14 days
- Hematology: ANC ≥ 1.5×10⁹/L, Hb ≥ 80 g/L, PLT ≥ 50×10⁹/L
- Liver function: TBIL ≤ 1.5×ULN, AST/ALT ≤ 5.0×ULN, ALB ≥ 28 g/L
- Coagulation function: INR, PT or aPTT ≤ 1.5×ULN
- Renal function: SCr ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min
- Urine protein ≤ 1+ or 24-hour urine protein < 1.0 g
- Cardiac function: LVEF ≥ 50%
- Females of childbearing potential with negative pregnancy test within 3 days before first dosing
- Fertile male and female patients agree to effective contraception from screening to 120 days after last study drug
- HBV/HCV infected patients receive stable antiviral therapy without drug interaction
Who cannot join
- Active or untreated CNS metastases; inadequately controlled metastatic brain or leptomeningeal disease
- Uncontrolled tumor-related pain
- Thromboembolic disease, ascites or lower limb edema within 6 months
- History of other malignancies within 5 years before randomization, except curable low-risk tumors
- Unresolved adverse toxicities from prior antitumor therapy not recovered to ≤ Grade 1 (CTCAE v5.0), excluding alopecia
- Pregnant, breastfeeding females or those planning pregnancy during the study
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- Any unstable medical, psychiatric or social condition that may interfere with study participation
- Positive HIV infection
- Major surgery within 28 days prior to randomization
- Severe cardiovascular disease, myocardial infarction, unstable arrhythmia, angina or cerebrovascular events
- Severe systemic infection within 4 weeks before dosing or active infection requiring systemic anti-infective treatment
- Impaired gastrointestinal absorption, long-term tube feeding, parenteral nutrition or eating disorders
- Concomitant use of other appetite-enhancing or weight-stimulating agents
- Cushing's syndrome, adrenal or pituitary insufficiency, poorly controlled diabetes
- Uncontrolled hypertension despite oral antihypertensive treatment
- Esophagogastric varices, severe ulcers, gastrointestinal bleeding, obstruction, perforation or fistula within 6 months
- Known hypersensitivity to any component of the investigational product
- Any other condition considered inappropriate for enrollment by the investigator.
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
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Guosheng Yuan, 86-020-13268121075, guoshengyuan1991@163.com
About this study
Official title: A Multicenter, Randomized, Controlled Phase II Clinical Trial of Nanocrystalline Megestrol Acetate Versus Placebo for Anorexia in Patients With Unresectable Hepatocellular Carcinoma Receiving TACE Combined With Targeted and Immunotherapy
Primary Objective: To evaluate the effect of nanocrystalline megestrol acetate versus placebo on body weight and appetite in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.Secondary Objectives: To evaluate the effect of nanocrystalline megestrol acetate versus placebo on quality of life, inflammatory markers, nutritional indicators, and psychological stress in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.Exploratory Objective: To explore the impact of nanocrystalline megestrol acetate versus placebo on survival benefit in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.
- Conditions
- Hepatocellular Carcinoma (HCC), Cachexia, Anorexia, Malnutrition
- Being tested
- Nanocrystalline megestrol acetate, Placebo
- Medical subject headings
- Carcinoma, Hepatocellular, Cachexia, Anorexia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanocrystalline megestrol acetateDrug
The dose of medroxyprogesterone used in this study was 625 mg/day. The first systemic treatment administration was defined as baseline, with continuous use of nanocrystalline medroxyprogesterone or placebo for 12 weeks during the antitumor therapy period.
PlaceboDrug
The first systemic treatment administration was defined as baseline, with continuous use of nanocrystalline medroxyprogesterone or placebo for 12 weeks during the antitumor therapy period.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
| Nanocrystalline megestrol acetate | Experimental | Not described Receives: Drug: Nanocrystalline megestrol acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with >5% weight loss from baseline.
Weight is measured in kilograms (kg).
Measured: Percentage weight change at Week 12 compared to baseline
Secondary outcomes (10)
L3-SMI
A single cross-sectional image of the third lumbar vertebra (L3) is obtained via CT/MRI scanning. Skeletal muscles at the L3 level, including the psoas major, erector spinae, quadratus lumborum, transversus abdominis, external oblique, and internal oblique muscles, are identified and quantified. The total skeletal muscle area of this slice is calculated using image analysis software such as Slice-O-Matic or ImageJ. The L3 skeletal muscle index (L3-SMI) is then derived by dividing the total muscle area by the square of height.
Measured: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).
The incidence and severity of adverse events (AEs) assessed by CTCAE5.0
Measured: Adverse events (AEs) of each subject will be followed up for 30 days after the last dose of nanocrystalline megestrol acetate or until the initiation of new anti-tumor therapy, whichever occurs first.
Objective Response Rate
Measured: Baseline(day1), and after every two treatment cycles(up to 2 years).each cycle lasts 21-28 days.
Life quality
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) contains 30 items to evaluate health-related quality of life in cancer patients.
The global quality of life scale is scored from 1 to 7. All other items use a 4-point scale (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much). The raw score of each domain is the average score of its corresponding items. All raw scores are linearly converted to standardized scores ranging from 0 to 100 for unified comparison.For functional scales, the standardized score is calculated as: [1 - (RS-1)/range] × 100. The range refers to the score interval of each domain, namely the difference between the maximum and minimum values.
Higher scores in functional domains and the global quality of life scale represent better function and quality of life. Higher scores on symptom scales and single-item measurements reflect more severe symptoms or health-related problems.
Measured: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).
Overall Survival
Overall survival was defined as the time from randomization to death from any cause.
Measured: Baseline(day 1); prior to dosing in each systemic treatment cycle(up to 2 years,each cycle is 21-28 days), assessed up to 100 weeks.
Inflammatory markers
CRP：C-reactive protein IL-6：Interleukin-6 IL-1：Interleukin-1
Measured: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).
Anxiety and depression
Anxiety and depression were assessed using the following two scales respectively.
Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9). Developed based on DSM-IV depression criteria, this 9-item scale evaluates depressive symptoms over the past two weeks. Each item is scored 0-3 points, with a total score ranging from 0 to 27. Higher total scores indicate more severe depressive symptoms. A score of ≥1 on Item 9 suggests suicidal risk. The PHQ-9 is used only for screening, not formal depression diagnosis.
Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). This 7-item international scale evaluates anxiety conditions in the previous two weeks. Each item adopts a 4-point scoring method, with a total score of 0-21. Higher scores correspond to increased anxiety severity.
Measured: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).
Progression-Free Survival
Progression-free survival was defined as the time from randomization to tumor progression or death, whichever occurred first.
Measured: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days)with a maximum follow-up of 100 weeks.
Appetite status assessment
The A/CS-12 is a subscale of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT). It enables quantitative and qualitative assessment of anorexia. Each item is scored from 0 to 4 points, with a total score ranging from 0 to 48. Lower scores indicate poorer appetite status.
Measured: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).
Nutritional indicators
Albumin (ALB),Hemoglobin (Hb)
Measured: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start22 Jun 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565415
- Sponsor's protocol ID
- NFEC-2025-731
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Phase II Clinical Trial of Nanocrystalline Megestrol Acetate Versus Placebo for Anorexia in Patients With Unresectable Hepatocellular Carcinoma Receiving TACE Combined With Targeted and Immunotherapy
- ClinicalTrials.gov ID
- NCT07565415
- Acronym / sponsor ID
- NFEC-2025-731
- Conditions
- Hepatocellular Carcinoma (HCC), Cachexia, Anorexia, Malnutrition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 4 May 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.
Primary Objective: To evaluate the effect of nanocrystalline megestrol acetate versus placebo on body weight and appetite in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.Secondary Objectives: To evaluate the effect of nanocrystalline megestrol acetate versus placebo on quality of life, inflammatory markers, nutritional indicators, and psychological stress in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.Exploratory Objective: To explore the impact of nanocrystalline megestrol acetate versus placebo on survival benefit in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Placebo |
| Nanocrystalline megestrol acetate | Experimental | Drug: Nanocrystalline megestrol acetate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients with unresectable primary hepatocellular carcinoma (HCC) confirmed by imaging or histopathology
- No previous receipt of immunotherapy and/or targeted drug therapy
- Child-Pugh score ≤ 7
- At least one measurable lesion per RECIST 1.1 criteria; lesions without prior radiotherapy, cryotherapy or other local treatment
- Single intrahepatic lesion < 10 cm, or fewer than 10 intrahepatic lesions with tumor burden < 50%
Key exclusion criteria (18 listed)
- Active or untreated CNS metastases; inadequately controlled metastatic brain or leptomeningeal disease
- Uncontrolled tumor-related pain
- Thromboembolic disease, ascites or lower limb edema within 6 months
- History of other malignancies within 5 years before randomization, except curable low-risk tumors
- Unresolved adverse toxicities from prior antitumor therapy not recovered to ≤ Grade 1 (CTCAE v5.0), excluding alopecia
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 acetateThe dose of medroxyprogesterone used in this study was 625 mg/day. The first systemic treatment administration was defined as baseline, with continuous use of nanocrystalline medroxyprogesterone or placebo for 12 weeks during the antitumor therapy period. | Drug | Nanocrystalline megestrol acetate |
| PlaceboThe first systemic treatment administration was defined as baseline, with continuous use of nanocrystalline medroxyprogesterone or placebo for 12 weeks during the antitumor therapy period. | Drug | Placebo group |
Primary outcome
The proportion of patients with >5% weight loss from baseline.
Time frame: Percentage weight change at Week 12 compared to baseline
Weight is measured in kilograms (kg).
10 secondary outcomes
L3-SMI
Time frame: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).
The incidence and severity of adverse events (AEs) assessed by CTCAE5.0
Time frame: Adverse events (AEs) of each subject will be followed up for 30 days after the last dose of nanocrystalline megestrol acetate or until the initiation of new anti-tumor therapy, whichever occurs first.
Objective Response Rate
Time frame: Baseline(day1), and after every two treatment cycles(up to 2 years).each cycle lasts 21-28 days.
Life quality
Time frame: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).
Overall Survival
Time frame: Baseline(day 1); prior to dosing in each systemic treatment cycle(up to 2 years,each cycle is 21-28 days), assessed up to 100 weeks.
Inflammatory markers
Time frame: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).
Anxiety and depression
Time frame: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).
Progression-Free Survival
Time frame: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days)with a maximum follow-up of 100 weeks.
Appetite status assessment
Time frame: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).
Nutritional indicators
Time frame: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).
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 4 May 2026.
- Individual participant dataSharing planned: Yes
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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 2 study testing Nanocrystalline megestrol acetate in people with Hepatocellular Carcinoma (HCC) and Cachexia, run by Nanfang Hospital, Southern Medical University 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 22 inclusion and 18 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 4 May 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Guosheng Yuan (86-020-13268121075, guoshengyuan1991@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with >5% weight loss from baseline. (time frame: Percentage weight change at Week 12 compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.