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.
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
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
Parallel
Nanocrystalline megestrol acetate
DrugThe 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.
Placebo
DrugThe first systemic treatment administration was defined as baseline, with continuous use of nanocrystalline medroxyprogesterone or placebo for 12 weeks during the antitumor therapy period.
The proportion of patients with >5% weight loss from baseline.
Weight is measured in kilograms (kg).
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.
The incidence and severity of adverse events (AEs) assessed by CTCAE5.0
Objective Response Rate
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.
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