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This study is a prospective, randomized, parallel-controlled, multicenter clinical study. The purpose of this study is to evaluate the efficacy and safety of nanocrystalline megestrol acetate combined with the first-line standard immunochemotherapy regimen compared with the first-line standard immunochemotherapy regimen in the treatment of anorexia and cachexia in advanced gastric and esophageal cancer. Eligible patients with gastric and esophageal cancer will be randomly assigned in a 1:1 ratio to the nanocrystalline megestrol acetate combination group (referred to as the megestrol acetate group for short) or the first-line standard immunochemotherapy group (referred to as the standard control group for short).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Megestrol Acetate Group | Experimental |
| |
| First-Line Standard Immuno-Chemotherapy Regimen | Other | Control Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanocrystal Megestrol Acetate in Combination with First-Line Standard Immuno-Chemotherapy Regimen | Drug | Megestrol Acetate Nanocrystal Oral Suspension Group: Nanocrystal Megestrol Acteate Oral Suspension (QD, up to 16 weeks from the initiation of immuno-chemotherapy) + PD-1 inhibitor (Q3W, until PD) + Chemotherapy regimen (TP regimen or XELOX regimen or SOX regimen selected based on cancer type, Q3W, as per package insert) |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Quality of Life for Patients with Advanced Gastric Cancer and Esophageal Cancer | Quality of Life Questionnaire (EORTC QLQ-C30; Physicians' Global Assessment score). The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a 30-item instrument, assesses health-related quality of life in cancer patients. The scale assesses 15 domains: 5 functional scales, 3 symptom scales, 6 single-item measures, and 1 global quality of life scale. Compared to baseline, a score change of ≥10 points in functional scales or the global quality of life scale indicates clinical significance (higher scores represent better functioning or quality of life). For symptom scales/single-item measures, a score increase ≥10 points signifies deterioration (higher scores indicate more severe symptoms or problems). An improvement is defined as either a ≥10-point increase in functional scale scores or a ≥10-point decrease in symptom scale scores. | 1year |
| Changes in Body Weight Relative to Baseline in Patients with Advanced Gastric and Esophageal Cancers |
| 1year |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on Survival Benefits in Patients with Advanced Gastric and Esophageal Cancers | Progression-Free Survival | 1year |
| Impact on Survival Benefits in Patients with Advanced Gastric and Esophageal Cancers |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shen Lin | Contact | 15801503311 | doctorshenlin@sina.cn |
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|
| First-Line Standard Immuno-Chemotherapy Regimen | Drug | PD-1 inhibitor (Q3W, until PD) + Chemotherapy regimen (TP regimen or XELOX regimen or SOX regimen selected based on cancer type, Q3W, as per package insert) |
|
Overall Survival
| 1year |
| Impact on Body Composition in Patients with Advanced Gastric and Esophageal Cancers | L3-CT (Skeletal Muscle） | 1year |
| Impact on Body Composition in Patients with Advanced Gastric and Esophageal Cancers | Appetite (Functional Assessment of Anorexia/Cachexia Therapy - Anorexia/Cachexia Subscale 12, FAACT-A/CS-12) | 1year |