Nanocrystalline Megestrol Acetate Versus Placebo for Anorexia in Patients With Unresectable Hepatocellular Carcinoma Receiving TACE Combined With Targeted and Immunotherapy

April 27, 2026 updated by: Nanfang Hospital, Southern Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo group
Drug: Placebo
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.
Experimental: Nanocrystalline megestrol acetate
Drug: Nanocrystalline megestrol acetate
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Percentage weight change at Week 12 compared to baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
L3-SMI
Time Frame: Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).
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.
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.
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.
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).

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.
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.
Overall survival was defined as the time from randomization to death from any cause.
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).
CRP：C-reactive protein IL-6：Interleukin-6 IL-1：Interleukin-1
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).

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.
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.
Progression-free survival was defined as the time from randomization to tumor progression or death, whichever occurred first.
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).
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.
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).
Albumin (ALB),Hemoglobin (Hb)
Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NFEC-2025-731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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