Clinical Study on the Treatment of Anorexia and Cachexia in Advanced Gastric and Esophageal Cancer With Nanosized Megestrol Acetate Combined With Immunochemotherapy

Phase 4

Not yet recruiting

• Conditions: Advanced Gastroesophageal Cancer
• Interventions: Drug: Nanocrystal Megestrol Acetate in Combination with First-Line Standard Immuno-Chemotherapy Regimen; Drug: First-Line Standard Immuno-Chemotherapy Regimen

• Registration Number: NCT06963593
• Lead Sponsor: Peking University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-10
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09
• Study Start: 2025-06-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Megestrol Acetate Group	Nanocrystal Megestrol Acetate in Combination with First-Line Standard Immuno-Chemotherapy Regimen	-
First-Line Standard Immuno-Chemotherapy Regimen	First-Line Standard Immuno-Chemotherapy Regimen	Control Group

Primary Outcome Measures

Name	Time	Method
Improvement in Quality of Life for Patients with Advanced Gastric Cancer and Esophageal Cancer	1year	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.
Changes in Body Weight Relative to Baseline in Patients with Advanced Gastric and Esophageal Cancers	1year	1. Body weight (kg); 2. Height (m); 3. BMI (kg/m², calculated from weight and height).

Secondary Outcome Measures

Name	Time	Method
Impact on Survival Benefits in Patients with Advanced Gastric and Esophageal Cancers	1year	Overall Survival
Impact on Body Composition in Patients with Advanced Gastric and Esophageal Cancers	1year	Appetite (Functional Assessment of Anorexia/Cachexia Therapy - Anorexia/Cachexia Subscale 12, FAACT-A/CS-12)