CompletedPhase 3

Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors

China754 participantsStarted 2022-09-21

Plain-language summary

To evaluate the efficacy and safety of HR20013 for injection for prevention of chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 18 years of age or older, of either gender
✓. Has a diagnosed malignant tumor
✓. has never been treated with chemotherapy and is to receive the first course of cisplatin-based chemotherapy
✓. Predicted life expectancy of ≥ 3 months
✓. Has a performance status (ECOG scale) of 0 to 1
✓. Adequate bone marrow, kidney, and liver function
✓. Women of childbearing potential must have negative pregnancy test (serum test) results within 72 hours prior to enrollment
✓. Able and willing to provide a written informed consent

Exclusion criteria

✕. Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -7 through Day 8
✕. Scheduled to receive any other chemotherapeutic agent with an high emetogenicity level from Day 2 through Day 8
✕. Has taken the following agents within the last 48 hours 5-HT3 antagonists, Phenothiazines, Benzamides, Domperidone, Cannabinoids, Benzodiazepines
✕. Subjects receiving palonosetron hydrochloride within 14 days before randomization
✕. Subjects who previously received NK-1 receptor antagonists within 28 days prior to randomization
✕. Subjects with a history of myocardial infarction or unstable angina pectoris
✕. Subjects with atrioventricular block or cardiac insufficiency
✕. Subjects with poor blood pressure control after medication

What they're measuring

Complete response during the overall phase after the start of the first cisplatin administration

Timeframe: 0-120 hours after the start of the first cisplatin administration

Trial details

NCT IDNCT05509634

SponsorFujian Shengdi Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-19

View on ClinicalTrials.gov More Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy trials