NCT05509634已完成3 期
Compared With Fosaprepitant Dimeglumine for Injection and Palonosetron Hydrochloride Injection, to Evaluate the Efficacy and Safety of HR20013 for Injection for Prevention of Chemotherapy-induced Nausea and Vomiting After Highly Emetogenic Chemotherapy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 754
- 试验地点
- 1
- 主要终点
- Complete response during the overall phase after the start of the first cisplatin administration
研究概览
简要总结
To evaluate the efficacy and safety of HR20013 for injection for prevention of chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Subjects with symptomatic brain metastases or any symptoms suggestive of brain metastasis or intracranial hypertension
- •Subjects who have experienced emetic events (vomiting or dry vomiting) or nausea within 24 hours before randomization
- •Participated in clinical trials of other drugs (received experimental drugs)
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial
研究组 & 干预措施
Treatment group A
Experimental
HR20013 for injection + simulant of fosaprepitant dimeglumine for injection + simulant of palonosetron hydrochloride injection + dexamethasone
干预措施: HR20013 for injection；dexamethasone (Drug)
Treatment group B
Active Comparator
simulant of HR20013 for injection + fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone + simulant of dexamethasone
干预措施: fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone (Drug)
结局指标
主要结局
Complete response during the overall phase after the start of the first cisplatin administration
时间窗: 0-120 hours after the start of the first cisplatin administration
To compare the rate of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) after the start of the first cisplatin administration.
次要结局
- No nausea(the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration)
- Complete response during the acute phase, the delayed phase, >120-168 hours, and 0-168 hours after the start of the first cisplatin administration(the acute phase (0-24 hours), the delayed phase (>24-120 hours), >120-168 hours, and 0-168 hours after the first cisplatin administration)
- Complete response during the acute phase, the delayed phase, the overall phase, >120-168 hours, and 0-168 hours after the start of the second cisplatin administration(the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours, and 0-168 hours after the start of the second cisplatin administration)
- No significant nausea(the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration)
- plasma concentration of HR20013(Evaluation time points include 1-2 hours, 5-10 hours, and 3 days after the start of the first HR20013 administration, and day 1 of the second HR20013 administration)
- The score using the functional living index-emesis (FLIE) questionnaire(During 0-168 hours after the start of each cisplatin administration)
- No emetic(the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration)
- No rescue medication(the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration)
- Total control(the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration)
- Time to treatment failure(During 0-168 hours after the start of each cisplatin administration)
- Number of participants with injection site reaction and with treatment-related adverse events as assessed by CTCAE v5.0(0 to 504 hours after the start of each cisplatin administration)
- Complete protection(the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration)
研究者
研究点 (1)
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