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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
220
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)
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)
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.
Time frame: 1year
Changes in Body Weight Relative to Baseline in Patients with Advanced Gastric and Esophageal Cancers
1. Body weight (kg); 2. Height (m); 3. BMI (kg/m², calculated from weight and height).
Time frame: 1year
Impact on Survival Benefits in Patients with Advanced Gastric and Esophageal Cancers
Progression-Free Survival
Time frame: 1year
Impact on Survival Benefits in Patients with Advanced Gastric and Esophageal Cancers
Overall Survival
Time frame: 1year
Impact on Body Composition in Patients with Advanced Gastric and Esophageal Cancers
L3-CT (Skeletal Muscle）
Time frame: 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)
Time frame: 1year
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