Cachexia, Hepatocellular Carcinoma
Conditions
Brief summary
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.
Interventions
Nanocrystalline Megestrol Acetate oral suspension, with a specification of 125 mg/mL, administered orally at a dose of 5 mL per day (625 mg/day), and the primary endpoint efficacy collection will be conducted in the 4th week.
COMBINATION_PRODUCTStandard Antitumor Therapy
Standard Antitumor Therapy
Sponsors
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with improved appetite based on A/CS-12 assessment. | The proportion of subjects with improved appetite based on A/CS-12 assessment in 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with BMI increase | Proportion of patients with BMI increase in 12 weeks |
Countries
China
Contacts
CONTACTChang Liu
Outcome results
None listed