Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma

GeneScience Pharmaceuticals (GenSci)

Status and phase: Not yet enrolling; Phase 3

Conditions: Hepatocellular Carcinoma; Cachexia

Treatments: Combination Product: Standard Antitumor Therapy; Drug: Nanocrystalline Megestrol Acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT07356037

EpiCure-HCC 01

Details and patient eligibility

About

This study is a prospective, randomized, parallel-controlled clinical trial. The primary objective is to evaluate the superiority and safety of nanocrystalline megestrol acetate in combination with standard therapy compared with standard therapy alone in improving appetite and body mass index (BMI) during treatment in patients with early-stage or locally advanced hepatocellular carcinoma at the cachexia stage.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with hepatocellular carcinoma who have not previously received systemic therapy and are confirmed by histological or cytological assessment, as evaluated by the investigator, to be unsuitable or ineligible for curative surgical resection; Barcelona Clinic Liver Cancer (BCLC) stage B-C.
2. Child-Pugh class A or B7.
3. Planned to receive interventional therapy in combination with systemic antitumor therapy.
4. At least one measurable tumor lesion according to mRECIST v1.1.
5. Meet the diagnostic criteria for pre-cachexia or cachexia (based on the Fearon criteria).

Exclusion criteria

1. Presence of any condition affecting gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrolled vomiting; patients receiving tube feeding or parenteral nutrition.
2. Presence of anorexia due to anorexia nervosa, psychiatric disorders, or pain that makes eating difficult.
3. Patients with acquired immunodeficiency syndrome (AIDS).
4. Currently receiving or planning to receive other medications that increase appetite or body weight, such as corticosteroids (except short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.
5. Patients with Cushing's syndrome, adrenal or pituitary insufficiency, or poorly controlled diabetes mellitus.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy

Experimental group

Description:

Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy

Treatment:

Drug: Nanocrystalline Megestrol Acetate

Combination Product: Standard Antitumor Therapy

Standard Antitumor Therapy

Active Comparator group

Description:

Standard Antitumor Therapy

Treatment:

Combination Product: Standard Antitumor Therapy