Not Yet RecruitingPhase 2

Megestrol Acetate Oral Suspension for Cachexia in Patients With cStage III Gastric/Gastroesophageal Junction Adenocarcinoma Receiving Neoadjuvant Therapy With Serplulimab Combined With SOX

China48 participantsStarted 2026-02-15

Plain-language summary

This study is an open-label, prospective, randomized controlled phase II clinical study. The purpose is to evaluate the efficacy and safety of megestrol acetate oral suspension for patients with cachexia and cStage III gastric/gastroesophageal junction adenocarcinoma who receive neoadjuvant therapy with serplulimab combined with SOX. This study intends to include 48 patients with locally advanced gastric adenocarcinoma who have not received any treatment, meet the diagnosis of cachexia, and are operable as research subjects. It is expected that 32 patients will be included in the experimental group and 16 patients will be included in the control group, with an inter-group ratio of approximately 2:1. After signing the informed consent, the patients will be screened and meet the inclusion and exclusion criteria. The groups will be assigned according to the random results. The patients will receive or not receive megestrol acetate oral suspension during the 3 cycles of serplulimab SOX regimen before surgery. After the second and third cycles of medication, the efficacy of neoadjuvant therapy and the possibility of radical gastric cancer D2 resection will be evaluated by imaging examinations, and radical gastric cancer surgery will be performed within 2-6 weeks after the third dose is completed. The treatment of postoperative patients will be decided by clinicians and patients based on actual clinical diagnosis and treatment. Patients must be given study drug treatment within 7 days after randomization. The dosing window for each cycle after the first dose is ±7 days. Before each dose, patients must complete the corresponding examinations specified in the protocol to assess the safety and tolerability of the treatment. Dosage regimen: * Treatment group: megestrol acetate oral suspension + serplulimab + SOX * Control group: serplulimab + SOX

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Voluntary signing of written informed consent;
✓. Age at enrollment ≥ 18 years and ≤ 80 years;
✓. Eastern Cooperative Oncology Group (ECOG, see Appendix 4) physical status score of 0-2;
✓. Expected survival ≥ 6 months;
✓. According to the 8th edition of AJCC gastric cancer staging, patients with cStage III (cT3-4aN1-3M0) assessed by abdominal CT and diagnosed with G/GEJ adenocarcinoma by gastroscopy and pathology, and only Siewert III type and Siewert II type subjects who do not require combined thoracotomy are allowed to be enrolled in gastroesophageal junction (GEJ) cancer;
✓. Meet the diagnostic criteria for cachexia (based on Fearon diagnostic criteria).
✓. Before enrollment, a gastrointestinal surgeon and an imaging physician jointly evaluated and determined that the tumor was cStage III and eligible for R0 resection with the purpose of cure. The patient agreed to undergo radical surgery and was judged by the surgeon to have no contraindications to surgery;
✓. No previous systemic treatment for the current disease, including surgical treatment, anti-tumor chemoradiotherapy/immunotherapy, etc.;

Exclusion criteria

What they're measuring

The proportion of patients whose weight did not decrease

Timeframe: From the date of the first neoadjuvant therapy until the date of radical surgery,assessed up to 6 months

Trial details

NCT IDNCT07391826

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Stage III Gastric Cancer trials