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

27. April 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

88

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo-Gruppe
Arzneimittel: 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
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The proportion of patients with >5% weight loss from baseline.
Zeitfenster: Percentage weight change at Week 12 compared to baseline
Weight is measured in kilograms (kg).
Percentage weight change at Week 12 compared to baseline

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
L3-SMI
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Nanfang Hospital, Southern Medical University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

22. Juni 2026

Primärer Abschluss (Geschätzt)

1. September 2027

Studienabschluss (Geschätzt)

1. September 2027

Studienanmeldedaten

Zuerst eingereicht

13. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. April 2026

Zuerst gepostet (Tatsächlich)

4. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NFEC-2025-731

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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