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

NCT07565415 | Not Yet Recruiting Phase 2

• 1 other identifier: NFEC-2025-731
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC); Cachexia; Anorexia; Malnutrition

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with >5% weight loss from baseline.

  Weight is measured in kilograms (kg).

  Percentage weight change at Week 12 compared to baseline

Secondary Outcomes (10)

• L3-SMI

  Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).

• The incidence and severity of adverse events (AEs) assessed by CTCAE5.0

  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.

• Objective Response Rate

  Baseline(day1), and after every two treatment cycles(up to 2 years).each cycle lasts 21-28 days.

• Life quality

  Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).

• Overall Survival

  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.

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Nanocrystalline megestrol acetate

EXPERIMENTAL

Drug: Nanocrystalline megestrol acetate

Interventions

Nanocrystalline megestrol acetate DRUG

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.

Nanocrystalline megestrol acetate

Placebo DRUG

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 group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cachexia; Anorexia; Malnutrition

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Signs and Symptoms, Digestive; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Guosheng Yuan

CONTACT

86-020-13268121075; guoshengyuan1991@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)