NCT07081256已完成3 期
A Multicenter, Randomized, Double-blind, Double-dummy, Positive-controlled Phase III Trial, to Evaluate the Efficacy and Safety of QLM2010 for Prevention of Chemotherapy-induced Nausea and Vomiting After Highly Emetogenic Chemotherapy
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 665
- 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
Compared With Fosaprepitant dimeglumine for Injection and Palonosetron Hydrochloride Injection, to Evaluate the Efficacy and Safety of QLM2010 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
- •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
排除标准
- •.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
- •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
研究组 & 干预措施
Treatment group A
Experimental
QLM2010 + dexamethasone
干预措施: QLM2010 for injection；dexamethasone (Drug)
Treatment group B
Active Comparator
fosaprepitant dimeglumine + palonosetron + 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: [Time Frame: 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
未报告次要终点
研究者
研究点 (1)
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