NCT Number: NCT06963593
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).
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 4
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
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)
Time frame: 1year
Quality of Life Questionnaire (EORTC QLQ-C30; Physicians' Global Assessment score). The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a 30-item instrument, assesses health-related quality of life in cancer patients. The scale assesses 15 domains: 5 functional scales, 3 symptom scales, 6 single-item measures, and 1 global quality of life scale. Compared to baseline, a score change of ≥10 points in functional scales or the global quality of life scale indicates clinical significance (higher scores represent better functioning or quality of life). For symptom scales/single-item measures, a score increase ≥10 points signifies deterioration (higher scores indicate more severe symptoms or problems). An improvement is defined as either a ≥10-point increase in functional scale scores or a ≥10-point decrease in symptom scale scores.
Time frame: 1year
Time frame: 1year
Progression-Free Survival
Time frame: 1year
Overall Survival
Time frame: 1year
L3-CT (Skeletal Muscle）
Time frame: 1year
Appetite (Functional Assessment of Anorexia/Cachexia Therapy - Anorexia/Cachexia Subscale 12, FAACT-A/CS-12)
Contact information is provided by the study sponsor or research team.
Peking University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
