To Evaluate the Efficacy and Safety of QLM2010 for Prevention of Chemotherapy-induced Nausea and Vomiting After Highly Emetogenic Chemotherapy.
Not Applicable
Recruiting
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Interventions
- Drug: QLM2010 for injection；dexamethasone
- Registration Number
- NCT07081256
- Lead Sponsor
- Qilu Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 664
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group A QLM2010 for injection；dexamethasone QLM2010 + dexamethasone Treatment group B fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone fosaprepitant dimeglumine + palonosetron + dexamethasone
- Primary Outcome Measures
Name Time Method Complete response during the overall phase after the start of the first cisplatin administration [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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Zhe jiangCancer Hospital
🇨🇳Hangzhou, China
Zhe jiangCancer Hospital🇨🇳Hangzhou, ChinaXiangdong Cheng, Chief PhysicianContact13968032995chengxd516@126.com