Fosrolapitant and Palonosetron for the Prevention of Antibody-drug Conjugate-induced Nausea and Vomiting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fosrolapitant and Palonosetron for injection.
- Who it may be relevant to
- Registry conditions: Nausea and Vomiting Induced by Antibody-drug Conjugates (ADCs). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Study of Fosrolapitant and Palonosetron for the Prevention of Nausea and Vomiting Induced by Antibody-Drug Conjugates in Cancer Patients
Overview
This study is aimed to evaluate the efficacy and safety of Fosrolapitant and Palonosetron for Antibody-drug conjugate-induced nausea and vomiting
Interventions
- Drug Fosrolapitant 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
Primary outcome measures
- Complete response rate [Time frame: Within 14 days after ADC administration]
Eligibility criteria
Inclusion criteria
\-
Exclusion criteria
- 18 years of age or older, of either gender
- Has a diagnosed malignant tumor
- has never been treated with ADCs and is to receive the first course of ADCs
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07692451 · HR20013-II-001