Megestrol Acetate Oral Suspension for Cachexia in Patients With cStage III Gastric/Gastroesophage… (NCT07391826) | Clinical Trial Compass
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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
. 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
. The patient has had other malignant tumors in the past (within 5 years) or concurrently. Patients with cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, stage I lung cancer, stage I colorectal cancer, etc. can be included in the group;
. Patients who are preparing for or have received organ or bone marrow transplantation in the past;
. Patients who have received blood transfusion within 2 weeks before the first medication, or have a history of bleeding, and have any severe bleeding events of grade 3 or above in CTCAE5.0 within 4 weeks before screening;
. Patients with abnormal coagulation function and bleeding tendency (INR is in the normal value \> 1.5 without the use of anticoagulants); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogs; On the premise that the international normalized ratio (INR) of prothrombin time is ≤1.5, low-dose warfarin (1 mg orally, once a day) or low-dose aspirin (daily dose not exceeding 100 mg) is allowed for preventive purposes;
. Arterial/venous thrombotic events within 6 months before screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except for venous thrombosis caused by intravenous catheterization during previous chemotherapy, which is judged by the researcher to have been cured) and pulmonary embolism;
. Myocardial infarction and poorly controlled arrhythmia (including QTc interval ≥450 ms for men and ≥470 ms for women) within 6 months before the first medication (QTc interval is calculated by Fridericia formula);
. NYHA standard III-IV heart failure or cardiac ultrasound examination: LVEF (left ventricular ejection fraction) \<50%;
. Urinalysis indicates urine protein ≥++ and confirms that the 24-hour urine protein quantification is \>1.0 g;