Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT07081256
Eligibility Criteria:
Inclusion Criteria:
* Able and willing to provide a written informed consent
* 18 years of age or older, of either gender
* Has a diagnosed malignant solid tumor through histological or cytological examination
* Has never been treated with chemotherapy (Antitumor drugs are not used for cancer treatment, or intravesical instillation therapy for bladder cancer is not regarded as chemotherapy)
* Receive the first course of cisplatin-based chemotherapy
* Has a performance status (ECOG scale) of 0 to 2
* Predicted life expectancy of ≥ 3 months
Exclusion Criteria:
* .Subjects with poor blood pressure control after medication
* Subjects with symptomatic brain metastases or any symptoms suggestive of brain metastasis or intracranial hypertension
* Subjects with a history of severe cardiovascular diseases within 3 months prior to the administration of cisplatin, such as acute myocardial infarction, NYHA class II-IV heart failure, etc.
* Subjects with a history of severe torsional ventricular tachycardia, QTcF\>480 ms
* Subjects with mental disabilities or severe emotional or mental disorders, The investigators determined that inappropriate for participation in this clinical trial
* Inadequate bone marrow, kidney, and liver function 10. Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -7 through Day 6
* Scheduled to receive moderately or highly emetogenic chemotherapy from Day 2 through Day 6
* Subjects who have experienced emetic events (vomiting or dry vomiting) or nausea within 24 hours before cisplatin-based chemotherapy
* Participated in clinical trials of other drugs within 30 days prior to the administration of cisplatin (received experimental drugs)
* Subjects receiving palonosetron hydrochloride within 21 days before cisplatin-based chemotherapy. Subjects who previously received NK-1 receptor antagonists within 28 days prior to cisplatin-based chemotherapy. Subjects receiving glucocorticoid within 7 days before cisplatin-based chemotherapy.
* Has taken the following agents within the last 48 hours 5-HT3 antagonists, Phenothiazines, Benzamides, Domperidone, Cannabinoids, Benzodiazepines, etc.
* The investigators determined that other conditions were inappropriate for participation in this clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07081256
Study Brief:
Protocol Section:
NCT07081256