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

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