Nausea and Vomiting Induced by Antibody-drug Conjugates (ADCs)
Conditions
Brief summary
This study is aimed to evaluate the efficacy and safety of Fosrolapitant and Palonosetron for Antibody-drug conjugate-induced nausea and vomiting
Interventions
DRUGFosrolapitant and Palonosetron for injection
• Experimental: Drug：Fosrolapitant and Palonosetron for injection Drug：Dexamethasone Drug: placebo • Active Comparator: Drug：HR20013 placebo Drug: fosaprepitant dimeglumine for injection Drug：Palonosetron injection Drug: Dexamethasone
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Drug: Fosrolapitant and Palonosetron；dexamethasone Drug: fosaprepitant dimeglumine for injection；palonosetron
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\-
Exclusion criteria
1. 18 years of age or older, of either gender 2. Has a diagnosed malignant tumor 3. has never been treated with ADCs and is to receive the first course of ADCs 4. Predicted life expectancy of ≥ 3 months 5. Has a performance status (ECOG scale) of 0 to 1 6. Adequate bone marrow, kidney, and liver function 7. Women of childbearing potential must have negative pregnancy test (serum test) results within 72 hours prior to enrollment 8. Able and willing to provide a written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate | Within 14 days after ADC administration |
Contacts
CONTACTli huiping chief physician
Outcome results
None listed