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

Peking University

Status and phase: Not yet enrolling; Phase 4

Conditions: Advanced Gastroesophageal Cancer

Treatments: Drug: Nanocrystal Megestrol Acetate in Combination with First-Line Standard Immuno-Chemotherapy Regimen; Drug: First-Line Standard Immuno-Chemotherapy Regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT06963593

2025YJZ29

Details and patient eligibility

About

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).

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Aged between 18 and 75 years old, regardless of gender；
2. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2；
3. The expected survival time is more than 3 months；
4. Good organ function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups

Megestrol Acetate Group

Experimental group

Treatment:

Drug: Nanocrystal Megestrol Acetate in Combination with First-Line Standard Immuno-Chemotherapy Regimen

First-Line Standard Immuno-Chemotherapy Regimen

Other group

Description:

Control Group

Treatment:

Drug: First-Line Standard Immuno-Chemotherapy Regimen