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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanfang Hospital, Southern Medical University

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

Treatment groups

88 Participants
are divided into 2 treatment groups