This study is aimed to evaluate the efficacy and safety of HR20013 versus palonosetron for nausea and vomiting associated with moderate emetic risk anticancer agents
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
706
HR20013 + dexamethasone + palonosetron placebo
Palonosetron + dexamethasone + HR20013 placebo
Sun Yat-sen University Cancer Center Yuexiu Campus
Guangzhou, Guangdong, China
Complete response rate in the delayed phase
To compare the rate of subjects achieving complete response (defined as no emetic episode and no need for rescue medication) in the delayed phase after initiation of moderate emetic risk anticancer agents.
Time frame: 24-120 hours after initiation of moderate emetic risk anticancer agents
Complete response rate in the overall phase.
To compare the rate of subjects achieving complete response (defined as no emetic episode and no need for rescue medication) in the overall phase after initiation of moderate emetic risk anticancer agents.
Time frame: 0 - 120 hours after initiation of moderate emetic risk anticancer agents
Complete response rate in the acute phase.
To compare the rate of subjects achieving complete response (defined as no emetic episode and no need for rescue medication) in the acute phase after initiation of moderate emetic risk anticancer agents.
Time frame: 0-24 hours after initiation of moderate emetic risk anticancer agents
Proportion of subjects with no significant nausea (maximum nausea on a visual analogue scale<25 mm)
To compare the proportion of subjects achieving no significant nausea (defined as maximum nausea on a visual analogue scale\<25 mm) in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Time frame: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with no nausea (maximum nausea on a visual analogue scale<5 mm)
To compare the proportion of subjects achieving no nausea (defined as maximum nausea on a visual analogue scale\<5 mm) in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
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Time frame: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with no emetic
To compare the proportion of subjects with no emetic event in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Time frame: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with no rescue medication
To compare the proportion of subjects with no rescue medication in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Time frame: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with complete protection
To compare the proportion of subjects achieving complete protection (defined as no emetic episode, no significant nausea and no need for rescue medication) in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Time frame: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with total control
To compare the proportion of subjects achieving total control (defined as no emetic episode, no nausea and no need for rescue medication) in the acute phase (0-24 hours), the delayed phase (24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Time frame: the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Time to treatment failure
Time to the first occurrence of emetic event or the first rescue medication
Time frame: 0-120 hours after initiation of moderate emetic risk anticancer agents
The score using the functional living index-emesis (FLIE) questionnaire
Changes in the score of FLIE before and after treatment
Time frame: 0-120 hours after initiation of moderate emetic risk anticancer agents
Adverse events
To analyse the rates of adverse events as assessed by CTCAE v5.0
Time frame: Approximately 4 weeks