Nanocrystalline Megestrol Acetate Versus Placebo for Anorexia in Patients With Unresectable Hepatocellular Carcinoma Receiving TACE Combined With Targeted and Immunotherapy
2026年4月27日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
88
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Guosheng Yuan
- 電話番号：86-020-13268121075
- メール：guoshengyuan1991@163.com
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510515
- Nanfang Hospital of Southern Medical University
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コンタクト：
- Guosheng Yuan
- 電話番号：86-020-13268121075
- メール：guoshengyuan1991@163.com
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター：プラセボ群
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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.
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実験的：Nanocrystalline megestrol acetate
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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The proportion of patients with >5% weight loss from baseline.
時間枠：Percentage weight change at Week 12 compared to baseline
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Weight is measured in kilograms (kg).
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Percentage weight change at Week 12 compared to baseline
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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L3-SMI
時間枠：Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).
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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.
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Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).
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The incidence and severity of adverse events (AEs) assessed by CTCAE5.0
時間枠：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.
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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.
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Objective Response Rate
時間枠：Baseline(day1), and after every two treatment cycles(up to 2 years).each cycle lasts 21-28 days.
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Baseline(day1), and after every two treatment cycles(up to 2 years).each cycle lasts 21-28 days.
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Life quality
時間枠：Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).
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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).
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Overall Survival
時間枠：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.
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Overall survival was defined as the time from randomization to death from any cause.
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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.
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Inflammatory markers
時間枠：Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).
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CRP：C-reactive protein IL-6：Interleukin-6 IL-1：Interleukin-1
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Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).
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Anxiety and depression
時間枠：Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).
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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).
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Progression-Free Survival
時間枠：Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days)with a maximum follow-up of 100 weeks.
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Progression-free survival was defined as the time from randomization to tumor progression or death, whichever occurred first.
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Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days)with a maximum follow-up of 100 weeks.
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Appetite status assessment
時間枠：Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).
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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.
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Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).
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Nutritional indicators
時間枠：Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).
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Albumin (ALB),Hemoglobin (Hb)
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Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月22日
一次修了 (推定)
2027年9月1日
研究の完了 (推定)
2027年9月1日
試験登録日
最初に提出
2026年4月13日
QC基準を満たした最初の提出物
2026年4月27日
最初の投稿 (実際)
2026年5月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月4日
QC基準を満たした最後の更新が送信されました
2026年4月27日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Placeboの臨床試験
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Shanghai Hengrui Pharmaceutical Co., Ltd.完了
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Palacky University完了