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 range18 Years
SexALL
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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;
✓. 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;
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.
✕. 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;