Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542549
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Efficacy and Safety of AK104 PD-1CTLA-4 Bispecial Antibody Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of AK104 PD-1CTLA-4 Bi-specific Antibody Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer a Randomized Controlled Single-center Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized controlled single-center clinical study to evaluate AK104 in FIGO 2018 stage III-IV ovarian cancer subjects who were assessed to be at high perioperative risk andor unable to achieve R0 resection prior to initial treatment The efficacy and safety of neoadjuvant therapy with intravenous infusion combined with chemotherapy compared with chemotherapy alone
Detailed Description:
Subjects in the experimental group received AK104 combined chemotherapy for 3-4 cycles determined by the investigator before surgery and subjects in the control group received chemotherapy for 3-4 cycles determined by the investigator before surgery Treatment until unless intolerable toxicity occurs informed consent is withdrawn or other criteria for discontinuation are met
The study treatment was followed by a 3-week treatment cycle The dosing time window is 3 days Within 72 hours before each dosing cycle subjects are required to complete various examinations including vital signs physical examination laboratory examination and physical status score to evaluate the safety and tolerability of continued treatment
The study treatment was followed by a 3-week treatment cycle The dosing time window is 3 days Within 72 hours before each dosing cycle subjects are required to complete various examinations including vital signs physical examination laboratory examination and physical status score to evaluate the safety and tolerability of continued treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None