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Gynecological TumorPhase 3NCT06007586

Prevention and Treatment of CINV Caused by TC Regimen in Gynecological Malignant Tumor Patients

A Phase 3 study testing Aprepitant Injection in people with Gynecological Tumor and Ovarian Cancer, run by Sichuan Cancer Hospital and Research Institute at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine the best method to prevent CINV caused by TC regimen in patients with gynecological malignant tumor. Paclitaxel-carboplatin (TC) is the most widely used regimen for gynecologic malignancies, yet chemotherapy-induced nausea and vomiting (CINV) remain common and distressing. Read more about this study

Who is it for?
Ages 20 to 75 years, women only
What is being tested?
Aprepitant Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
2 sitesChina
Study dates
31 May 2024to 4 Jul 2025
Phase
Phase 3
Are there results?
None posted in the registry

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 20 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Eligibility criteria: histologically confirmed gynecologic malignancies (including newly diagnosed cases and recurrent cases without chemo- or radiotherapy within the past six months); age 20-75 years; ECOG performance status 0-2; scheduled to receive at least two cycles of paclitaxel (175 mg/m²) plus carboplatin (AUC 5-6) every 3 weeks; and adequate organ function (bilirubin and creatinine within normal range, ALT and AST < 2× upper limit of normal).

Exclusion criteria: included prior chemotherapy, radiotherapy, or targeted therapy for the current recurrence; known brain metastases or history of brain tumors; history of gastrointestinal malignancy or major gastrointestinal surgery (except polypectomy or appendectomy); incomplete bowel obstruction; vestibular dysfunction; massive ascites (unless drained); concomitant opioid use; or diabetes mellitus.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Dengfeng Wang

    Chengdu, Sichua, 610041

  • Sichuan Cancer Hospital

    Chengdu

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Clinical Study on Prevention and Treatment of CINV Induced by TC Regimen in Gynecological Malignant Tumors

To determine the best method to prevent CINV caused by TC regimen in patients with gynecological malignant tumor.

Paclitaxel-carboplatin (TC) is the most widely used regimen for gynecologic malignancies, yet chemotherapy-induced nausea and vomiting (CINV) remain common and distressing. Optimal prophylaxis is uncertain. This trial evaluated whether adding the NK1 receptor antagonist aprepitant to standard two-drug prophylaxis (5-HT3 receptor antagonist plus dexamethasone) improves CINV control.

Read the detailed description

The risk of vomiting caused by high-dose carboplatin is controversial, and there is currently no prevention of TC in patients with gynecological malignant tumors High-level evidence-based medical evidence for programme-induced CINV. Therefore, different guidelines recommend the best antiemetic regimen as well It's different. This study is intended to conduct a prospective, multicenter, randomized, double-blind, placebo-controlled, crossover study The designed Phase III clinical study provides important data and basis for clinical practice and guideline formulation.

In this prospective, multicenter, double-blind, placebo-controlled, crossover phase III trial, patients with gynecologic malignancies scheduled for at least two cycles of TC were randomly assigned to receive aprepitant or placebo with ondansetron and dexamethasone during cycle 1, crossing over to the alternate regimen in cycle 2. The primary endpoint was complete response (CR: no emesis, no significant nausea and no rescue therapy) in the delayed phase (24-168 hours). Secondary endpoints included CR in acute and overall phases, nausea severity, rescue medication use, adverse events, and patient satisfaction.

Being tested
Aprepitant Injection
Keywords
Gynecologic Cancer, chemotherapy-induced nausea and vomiting, Paclitaxel-carboplatin
Medical subject headings
Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms, Vomiting

What participants receive

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

  • Aprepitant InjectionDrug

    Also called dexamethasone, ondansetron

    Two antiemetic groups use placebo, dexamethasone and ondansetron. Three antiemetic groups use aprepitant, dexamethasone and ondansetron.

Study groups in NCT06007586
Study groupRoleWhat they receive
Group AExperimentalpatients in group A received the two-drug antiemetic regimen (placebo cycle) during the first cycle followed by the three-drug regimen (aprepitant cycle) during the second cycle. The two-drug regimen (placebo cycle) consisted of intravenous placebo 130 mg, intravenous ondansetron 8 mg, and intravenous dexamethasone 12 mg, all administered 30 minutes before chemotherapy on day 1, followed by oral dexamethasone 8 mg once daily on days 2-4. The three-drug regimen (aprepitant cycle) replaced placebo with intravenous aprepitant 130 mg on day 1, with all other medications administered as in the two-drug regime
Receives: Drug: Aprepitant Injection
Group BExperimentalpatients in group B received the regimens in the reverse order. The three-drug regimen (aprepitant cycle) replaced placebo with intravenous aprepitant 130 mg on day 1, with all other medications administered as in the two-drug regime. The two-drug regimen (placebo cycle) consisted of intravenous placebo 130 mg, intravenous ondansetron 8 mg, and intravenous dexamethasone 12 mg, all administered 30 minutes before chemotherapy on day 1, followed by oral dexamethasone 8 mg once daily on days 2-4.
Receives: Drug: Aprepitant Injection

What is being measured

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

  1. Complete response (CR) rate in the delayed period

    CR is defined as no emesis, no significant nausea (VAS ≤4, where 0 = none, 10= = most severe), and no use of rescue antiemetics.

    Measured: 24 hours to 7days after chemotherapy (each cycle is 21 days)

Secondary outcomes (5)

  1. CR rates in the acute phase (0-24 hours) and overall phase (0-7 days).

    CR rates in the acute phase (0-24 hours) and overall phase (0-7 days).

    Measured: acute phase: within 24 hours after chemotherapy (each cycle is 21 days); overall phase: within 7 days after chemotherapy (each cycle is 21 days).

  2. the use of rescue antiemetic

    the use of rescue antiemetic (0-7 days)

    Measured: within 7 days after chemotherapy (each cycle is 21 days).

  3. patient satisfaction

    patient satisfaction assessed with a 7-point Likert-type scale (1=Very dissatisfied; 2=dissatisfied; 3=Relatively dissatisfied; 4=quite satisfied; 5=somewhat satisfied; 6=Satisfied; 7=Very satisfied)

    Measured: On day 7 and 14 of each cycle (each cycle is 21 days).

  4. AEs

    incidence of adverse events

    Measured: within 7 days after chemotherapy (each cycle is 21 days).

  5. severity of nausea

    severity of nausea (VAS: 0 = none, 10 = most severe)

    Measured: within 7 days after chemotherapy (each cycle is 21 days).

Timeline

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

  1. First posted23 Aug 2023
  2. Study start31 May 2024
  3. Primary completion20 Jun 2025
  4. Study completion4 Jul 2025

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06007586
Sponsor's protocol ID
CINV202306
Status last verified
Nov 2025
First submitted
11 Aug 2023
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aprepitant Injection in people with Gynecological Tumor and Ovarian Cancer, run by Sichuan Cancer Hospital and Research Institute at 2 sites in China.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Complete response (CR) rate in the delayed period (time frame: 24 hours to 7days after chemotherapy (each cycle is 21 days)). 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 NCT06007586.

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 4 Dec 2025.

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