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

NCT ID: NCT06963593

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-08-31

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).

Conditions

Advanced Gastroesophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Megestrol Acetate Group

Group Type: EXPERIMENTAL

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

Intervention Type: 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)

First-Line Standard Immuno-Chemotherapy Regimen

Control Group

Group Type: OTHER

First-Line Standard Immuno-Chemotherapy Regimen

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Shen Lin

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Shen Lin

Role: CONTACT

doctorshenlin@sina.cn

15801503311

Other Identifiers

2025YJZ29

Identifier Type: -

Identifier Source: org_study_id