AzTrials
AzTrials

Chemotherapy-Induced Nausea and Vomiting (CINV)Phase 2NCT07246070

Nano-crystalline Megestrol Acetate for Chemotherapy-induced Nausea and Vomiting

A Phase 2 study testing nanocrystalline megestrol acetate combined with ondansetron and dexamethasone combined with ondansetron in people with Chemotherapy-Induced Nausea and Vomiting (CINV), run by AIPING ZHOU.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
nanocrystalline megestrol acetate combined with ondansetron and dexamethasone combined with ondansetron
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
No sites listed yet
Study dates
Dec 2025to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 17Show fewer
  • Good organ function, meeting the following criteria:
  • Neutrophil count ≥ 1.5 × 10⁹/L;
  • Hemoglobin ≥ 90 g/L;
  • Platelet count ≥ 100 × 10⁹/L;
  • Total bilirubin ≤ 1.5 × ULN;
  • In patients without known liver metastases, aspartate aminotransferase ≤ 2.5 × ULN and/or alanine aminotransferase ≤ 2.5 × ULN (for patients with liver metastases, this may be relaxed to ≤ 5 × ULN);
  • Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min;
  • Electrocardiogram: QTc ≤ 450 ms (male), QTc ≤ 470 ms (female);
  • Echocardiogram: LVEF (left ventricular ejection fraction) ≥ 50%;
  • Female participants of childbearing potential, as well as male participants whose partners are of childbearing potential, must use an effective method of contraception from the time of signing the informed consent form until 6 months after the last dose; female participants of childbearing potential must have a negative blood pregnancy test within 72 hours prior to randomization; and must not be breastfeeding;
  • Clearly understand and voluntarily participate in this study, and sign the informed consent form personally.

Who cannot join

  • 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);
Show all 21Show fewer
  • 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:
  • Single-dose corticosteroids for contrast medium allergy prevention, as well as local administration or inhalation, are permitted);
  • Use of palonosetron within 14 days prior to enrollment;
  • Use of NK-1 receptor antagonists within 28 days prior to enrollment;
  • Use of specific CYP3A4 substrates (terfenadine, cisapride, astemizole) or CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, ketoconazole, or itraconazole, diltiazem, etc.), use of strong CYP3A4 inducers (e.g., phenobarbital, rifampin, phenytoin, and carbamazepine) within 28 days prior to enrollment, or use of specific CYP2D6 substrates (e.g., thioridazine, pimozide) within 28 days prior to enrollment;
  • Vomiting and/or nausea within 24 hours prior to enrollment;
  • Symptomatic brain metastases or any symptoms suggestive of brain metastases or intracranial hypertension;
  • Uncontrolled serous effusion, including pleural effusion, ascites, or pericardial effusion (patients who have achieved control through treatment and have been stable for ≥2 weeks may be included);
  • Severe cardiovascular disease within 3 months prior to enrollment, including but not limited to acute myocardial infarction, unstable angina, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic chronic heart failure (New York Heart Association [NYHA] Class II to IV), or history of severe cardiac conduction abnormalities (e.g., torsades de pointes);
  • Uncontrolled hypertension prior to enrollment (two consecutive resting systolic blood pressure readings ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
  • Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), active hepatitis C (HCV-Ab positive and HCV-RNA ≥ upper limit of normal), acquired immunodeficiency syndrome (AIDS) or HIV-positive, or syphilis-positive;
  • Concurrent conditions that preclude the use of dexamethasone, such as active infections (e.g., pneumonia) or any uncontrolled conditions (e.g., diabetic ketoacidosis, gastrointestinal obstruction, etc.);
  • Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, or dexamethasone;
  • Participation in other clinical trials within 30 days prior to enrollment (as determined by the use of study drugs);
  • Subjects deemed by the investigator to have other conditions that make them unsuitable for participation in this study.

About this study

Official title: The Efficacy and Safety of Nano-crystalline Megestrol Acetate for the Prevention of Nausea and Vomiting Caused by Emetogenic Chemotherapy: a Randomized, Controlled, Multicenter Clinical Study

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.

Being tested
nanocrystalline megestrol acetate combined with ondansetron, dexamethasone combined with ondansetron
Medical subject headings
Vomiting

What participants receive

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

  • nanocrystalline megestrol acetate combined with ondansetronDrug

    nanocrystalline megestrol acetate (5 ml PO, qd, Day 1-Day 14), ondansetron (8 mg IV, qd, Day 1).

  • dexamethasone combined with ondansetronDrug

    dexamethasone (8 mg IV, qd, Day 1), ondansetron (8 mg IV, qd, Day 1)

Study groups in NCT07246070
Study groupRoleWhat they receive
Single-arm study groupExperimentalNot described
Receives: Drug: nanocrystalline megestrol acetate combined with ondansetron
nanocrystalline megestrol acetate groupExperimentalNot described
Receives: Drug: nanocrystalline megestrol acetate combined with ondansetron
dexamethasone groupActive comparatorNot described
Receives: Drug: dexamethasone combined with ondansetron

What is being measured

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

  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.

    Measured: the entire period (Day 1-Day 21) after the start of chemotherapy drug administration in the first chemotherapy cycle.

Timeline

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

  1. First posted24 Nov 2025
  2. Study startDec 2025 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
127 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07246070
Sponsor's protocol ID
NCC5420
Status last verified
Nov 2025
First submitted
16 Sep 2025
Last updated
24 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nanocrystalline megestrol acetate combined with ondansetron and dexamethasone combined with ondansetron in people with Chemotherapy-Induced Nausea and Vomiting (CINV), run by AIPING ZHOU.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: the entire period (Day 1-Day 21) after the start of chemotherapy drug administration in the first chemotherapy cycle.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07246070.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in