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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy | Experimental | Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy |
|
| Standard Antitumor Therapy | Active Comparator | Standard Antitumor Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanocrystalline Megestrol Acetate | Drug | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with BMI increase | Proportion of patients with BMI increase in 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Liu | Contact | +86 18180464347 | drliuchang@wchscu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China School of Medicine/West China Hospital of Sichuan University | Chengdu | Sichuan | 610000 | China |
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| ID | Term |
|---|---|
| D002100 | Cachexia |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| Standard Antitumor Therapy | Combination Product | Standard Antitumor Therapy |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |