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

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

Detailed Description
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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.

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

Conditions
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Gynecological Tumor

Intervention / Treatment
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* Drug: Aprepitant Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-75 years old; ECOG PS：0～2; She was diagnosed as gynecological malignant tumor and was to receive TC chemotherapy; Carboplatin AUC 5～6mg/ml/min； Basically normal organ function (normal bilirubin level circumference, normal range of creatinine, ALT&lt; 2 times the upper limit of normal, AST&lt; 2 times the upper normal value) Exclusion Criteria: Patients with previous history of chemotherapy, radiotherapy or targeted therapy; Malignant tumors with brain metastases; History of gastrointestinal malignancy; History of brain tumor; Previous gastrointestinal surgery history, such as segmental resection, (partial) gastrectomy, except intestinal polyp resection and appendectomy; (incomplete) intestinal obstruction; Vestibular dysfunction; Massive abdominal accumulation liquid (except for those who have undergone puncture drainage); Opioid concomitant drug users; Diabetic.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Two antiemetic groups<br>Placebo 130mg iv d1 30min d1 before chemotherapy (IV time &gt; 2min);Ondansetron 8mg iv once d1 30min before chemotherapy; Dexamethasone 12mg iv once d1 before chemotherapy 30min, dexamethasone 8mg po qd d2   4. | Drug: Aprepitant Injection<br>* Two antiemetic groups use placebo,Dexamethasone and Ondansetron, Three antiemetic groups use Aprepitant,Dexamethasone and Ondansetron.<br>* Other names: Oribe;|
| Experimental: Three antiemetic group<br>Aprepitant injection 130mg iv d1 30min d1 before chemotherapy (push-back time &gt; 2min);Ondansetron 8mg iv once d1 30min before chemotherapy;Dexamethasone 12mg iv once d1 30min before chemotherapy, 8mg po qd d2-4. | Drug: Aprepitant Injection<br>* Two antiemetic groups use placebo,Dexamethasone and Ondansetron, Three antiemetic groups use Aprepitant,Dexamethasone and Ondansetron.<br>* Other names: Oribe;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response (CR) rate in the delayed period | CR is defined as a patient who does not need rescue antiemesis treatment, no vomiting or retching. | 24 hours to 7days |