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

NCT06963593 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-05-09

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-06-30
Completion
2027-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06963593 on ClinicalTrials.gov