Nano-crystalline Megestrol Acetate for Chemotherapy-induced Nausea and Vomiting (NCT07246070) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Nano-crystalline Megestrol Acetate for Chemotherapy-induced Nausea and Vomiting
127 participantsStarted 2025-12
Plain-language summary
The primary objective of this clinical study is to evaluate the efficacy and safety of nanocrystalline megestrol acetate combined with a 5-HT3 receptor antagonist for the prophylaxis of nausea and vomiting caused by moderately emetogenic chemotherapy drugs.
The study population consists of gastric adenocarcinoma patients who are scheduled to receive their first course of moderately emetogenic chemotherapy (PD-1/PD-L1 immune checkpoint inhibitors combined with the CAPOX regimen). This study is divided into two phases. The first phase is a single-arm study design, with the primary objective of preliminarily assessing the efficacy and safety of nanocrystalline megestrol acetate combined with a 5-HT3 receptor antagonist for the full-course management of nausea and vomiting caused by moderately emetogenic chemotherapy drugs. The second phase will adopt a randomized, controlled, multicenter trial design. Based on the efficacy and safety data from the first phase, the investigators will optimize the trial design (primarily including the primary endpoint and sample size calculation) to evaluate the efficacy and safety of nanocrystalline megestrol acetate compared with dexamethasone, each combined with a 5-HT3 receptor antagonist, for the prevention of nausea and vomiting caused by moderately emetogenic chemotherapy drugs.
Who can participate
Age range
18 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
. Age ≥ 18 years, no gender restrictions;
. Histologically or cytologically confirmed locally advanced/recurrent or metastatic gastric adenocarcinoma that is unresectable for curative treatment;
. No prior exposure to any chemotherapy drugs (anticancer drugs not used for cancer treatment, or intravesical instillation therapy for bladder cancer is not considered chemotherapy);
. First-line treatment planned to include a moderately emetogenic chemotherapy agent, specifically a PD-1 inhibitor (Tislelizumab is recommended), in combination with the CAPOX chemotherapy regimen for anticancer therapy;
. Expected survival ≥ 6 months;
. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
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 without nausea during the entire period (Day 1-Day 21) after the start of chemotherapy drug administration in the first chemotherapy cycle.
Timeframe: the entire period (Day 1-Day 21) after the start of chemotherapy drug administration in the first chemotherapy cycle.
. Good organ function, meeting the following criteria:
. Neutrophil count ≥ 1.5 × 10⁹/L;
Exclusion criteria
. Received abdominal (including the diaphragmatic plane and below) or pelvic radiotherapy within 7 days prior to enrollment, or plans to receive such radiotherapy between days 1 and 8 of treatment;
. Plans to administer other chemotherapy drugs with moderate to high emetogenic potential between days 2 and 8 following the first day of chemotherapy;
. History of venous thromboembolic disease within the past 6 months;
. Use of medications with potential antiemetic effects within 2 days prior to enrollment: 5-HT3 receptor antagonists (e.g., ondansetron), phenothiazines (e.g., chlorpromazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, or secobarbital;
. Initiation of benzodiazepine or opioid therapy within 2 days prior to enrollment (excluding zolpidem, temazepam, or midazolam taken alone daily);
. Initiation of morphine use within 7 days prior to enrollment (excluding those on a stable dose);
. Received systemic corticosteroid therapy (including but not limited to dexamethasone, hydrocortisone, methylprednisolone, or prednisolone) or sedating antihistamines (e.g., diphenhydramine) within 7 days prior to enrollment (Note:
. Use of palonosetron within 14 days prior to enrollment;