NCT06963593

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

Efficacy and Safety of Nanosized Megestrol Acetate Combined With Immunochemotherapy in the Treatment of Anorexia and Cachexia in Advanced Gastric and Esophageal Cancer: A Randomized, Controlled, Multicenter Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Advanced Gastroesophageal Cancer

Interventions

Type	Name	Description
DRUG	Nanocrystal Megestrol Acetate in Combination with First-Line Standard Immuno-Chemotherapy Regimen	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)
DRUG	First-Line Standard Immuno-Chemotherapy Regimen	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)

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-06-30
• Completion: 2027-08-31
• First posted: 2025-05-09
• Last updated: 2025-05-09