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To evaluate the efficacy and safety of HR20013 for injection for prevention of chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | HR20013 for injection + simulant of fosaprepitant dimeglumine for injection + simulant of palonosetron hydrochloride injection + dexamethasone |
|
| Treatment group B | Active Comparator | simulant of HR20013 for injection + fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone + simulant of dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR20013 for injection;dexamethasone | Drug | HR20013 for injection;Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response during the overall phase 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. | 0-120 hours after the start of the first cisplatin administration |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response during the acute phase, the delayed phase, >120-168 hours, and 0-168 hours after the start of the first cisplatin administration | To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) during the specified period. | the acute phase (0-24 hours), the delayed phase (>24-120 hours), >120-168 hours, and 0-168 hours after the first cisplatin administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center Yuexiu Campus | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39621965 | Derived | Zhou H, Zhao Y, Zhang M, Yao J, Leng S, Li X, Lin L, Chen J, Zhang S, Qin X, Qin Z, Yi T, Wang R, Li X, Yu Y, Wang Z, Zheng Q, Mei J, Zang A, Li N, Cao F, Cao K, Li W, Lu Y, Lin D, Zhou Y, Yang R, Fang W, Zhou N, Yang Y, Zhang Y, Chen G, Zhou T, Yang X, Wang H, Wang Y, Huang Y, Zhang L. Randomized, Phase III Trial of Mixed Formulation of Fosrolapitant and Palonosetron (HR20013) in Preventing Cisplatin-Based Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: PROFIT. J Clin Oncol. 2025 Mar 20;43(9):1123-1136. doi: 10.1200/JCO-24-01308. Epub 2024 Dec 2. |
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HR20013 for injection + dexamethasone compared with fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone
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| fosaprepitant dimeglumine for injection;palonosetron hydrochloride injection;dexamethasone | Drug | fosaprepitant dimeglumine for injection: Drug for preventing nausea and vomiting caused by chemotherapy palonosetron hydrochloride injection: Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy |
|
| Complete response during the acute phase, the delayed phase, the overall phase, >120-168 hours, and 0-168 hours after the start of the second cisplatin administration | To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) during the specified period. | the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours, and 0-168 hours after the start of the second cisplatin administration |
| No significant nausea | To compare the proportion of subjects with no significant nausea (defined as maximum nausea on a visual analogue scale <25 mm) during the specified period. | the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration |
| No nausea | To compare the proportion of subjects with no nausea (defined as maximum nausea on a visual analogue scale <5 mm) during the specified period. | the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration |
| No emetic | To compare the proportion of subjects with no emetic event during the specified period. | the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration |
| No rescue medication | To compare the proportion of subjects who received no rescue medication during the specified period. | the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration |
| Complete protection | To compare the proportion of subjects with complete protection (defined as patients who experienced no emetic event and received no rescue medication and had no significant nausea) during the specified period). | the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration |
| Total control | To compare the proportion of subjects with total control (defined as patients who experienced no emetic events and received no rescue medication and had no nausea) during the specified period. | the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration |
| Time to treatment failure | Time to the first occurrence of emetic event or the first rescue medication. | During 0-168 hours after the start of each cisplatin administration |
| The score using the functional living index-emesis (FLIE) questionnaire | To compare the change of score using FLIE questionnaire before and after treatment. | During 0-168 hours after the start of each cisplatin administration |
| Number of participants with injection site reaction and with treatment-related adverse events as assessed by CTCAE v5.0 | To compare the number of participants with injection site reaction and with treatment-related adverse events as assessed by CTCAE v5.0. | 0 to 504 hours after the start of each cisplatin administration |
| plasma concentration of HR20013 | To analyse the plasma concentration of HR20013 at the specified time points. | Evaluation time points include 1-2 hours, 5-10 hours, and 3 days after the start of the first HR20013 administration, and day 1 of the second HR20013 administration |
| ID | Term |
|---|---|
| C579707 | fosaprepitant |
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