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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 75 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Advanced Gastroesophageal Cancer

Being tested

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

  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 RegimenDrug

  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)

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Improvement in Quality of Life for Patients with Advanced Gastric Cancer and Esophageal Cancer

   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.

   Measured: 1year

2. Changes in Body Weight Relative to Baseline in Patients with Advanced Gastric and Esophageal Cancers

   1. Body weight (kg);
   2. Height (m);
   3. BMI (kg/m², calculated from weight and height).

   Measured: 1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted9 May 2025
2. Study start1 Jun 2025 (estimated)
3. Primary completion30 Jun 2027 (estimated)
4. Study completion31 Aug 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Advanced Gastroesophageal CancerStudies of the same condition, open and under way.
• More trials run by Peking UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.