Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420973
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-11
Brief Title:
RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression
Sponsor:
Peking University Cancer Hospital Institute
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
A Single-arm Multicenter Phase II Study of RC48 Plus Platinum With or Without Bevacizumab in the Treatment of HER-2 Expression Platinum-Sensitive Recurrent Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy safety and quality of life scores of patients with HER2-expressing platinum-sensitive recurrent epithelial ovarian cancer treated with the combination therapy regimen of RC48 plus platinum with or without bevacizumab
Detailed Description:
This study set up a safety introduction period during which the first 6 subjects who were initially enrolled in the study will slowly undergo safety monitoring Each patient received RC48 25 mgkg Q3Wcarboplatin AUC5 d1 q3w bevacizumab75-15mgkg d1 q3w treatment The monitoring time window is within 28 days after receiving the study drug treatment for the first time If 2 dose limited toxicity DLT cases were observed in the first 6 subjects and after evaluation by the research team it was found that the toxicity was related to treatment with RC48 the initial dose of RC48 treatment for subsequent enrolled patients was adjusted to 20mgkg Q3W
Treatment period RC48carboplatin bevacizumab repeated every three weeks for a total of 6 cycles Maintenance period RC48 bevacizumab if combined with bevacizumab during the treatment period maintain treatment with RC48 in combination with bevacizumab if not used during the treatment period maintain treatment with RC48 monotherapy Maintenance duration Until disease progression or intolerable toxicity occurs the longest duration of RC48 is 6 months 8 cycles
Treatment period RC48carboplatin bevacizumab repeated every three weeks for a total of 6 cycles Maintenance period RC48 bevacizumab if combined with bevacizumab during the treatment period maintain treatment with RC48 in combination with bevacizumab if not used during the treatment period maintain treatment with RC48 monotherapy Maintenance duration Until disease progression or intolerable toxicity occurs the longest duration of RC48 is 6 months 8 cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None