About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nanocrystalline megestrol acetate
- Placebo