Clinical Study on the Treatment of Anorexia and Cachexia in Advanced Gastric and Esophageal Cancer With Nanosized Megestrol Acetate Combined With Immunochemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nanocrystal Megestrol Acetate in Combination with First-Line Standard Immuno-Chemotherapy Regimen, First-Line Standard Immuno-Chemotherapy Regimen.
- Who it may be relevant to
- Registry conditions: Advanced Gastroesophageal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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).
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)
Primary outcome measures
- Improvement in Quality of Life for Patients with Advanced Gastric Cancer and Esophageal Cancer [Time frame: 1year]
- Changes in Body Weight Relative to Baseline in Patients with Advanced Gastric and Esophageal Cancers [Time frame: 1year]
Secondary outcome measures (4)
- Impact on Survival Benefits in Patients with Advanced Gastric and Esophageal Cancers [Time frame: 1year]
- Impact on Survival Benefits in Patients with Advanced Gastric and Esophageal Cancers [Time frame: 1year]
- Impact on Body Composition in Patients with Advanced Gastric and Esophageal Cancers [Time frame: 1year]
- Impact on Body Composition in Patients with Advanced Gastric and Esophageal Cancers [Time frame: 1year]
Eligibility criteria
- Aged between 18 and 75 years old, regardless of gender；
- The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2；
- The expected survival time is more than 3 months；
- Good organ function
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06963593 · 2025YJZ29