Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06188455
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-12-18
Brief Title:
Maintenance Therapy After Platinum-containing Chemotherapy in Patients With Recurrent Ovarian Cancer
Sponsor:
The First Affiliated Hospital of Xiamen University
Organization:
The First Affiliated Hospital of Xiamen University
Study Overview
Official Title:
Clinical Study of Fluzopalil Combined With Apatinib for Maintenance Therapy After Platinum-containing Chemotherapy in Patients With Recurrent Ovarian Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
Thirty-seven women aged 18-75 years with recurrent ovarian cancer were enrolled
Detailed Description:
The subjects selected surgery according to the actual situation and received chemotherapy containing platinum after surgery totaling 4 cycles of chemotherapy After the completion of the treatment course the researchers will use fluzoparil combined with apatinib to maintain the treatment until the disease progression in patients with CR PR and SD evaluated according to RECIST 11 efficacy
The medication regimen for all enrolled patients was recommended as follows and the dose could be adjusted during treatment due to adverse reactions and other circumstances
Fluzopalil capsules
Oral administration of 100 mg 2 capsulestime 50 mgcapsule twice a day in the morning and evening beforeafter meals can be taken orally it is recommended to take oral administration in the morning and late 05h continuous administration Every 4 weeks is a treatment period
Apatinib tablets
Oral administration of 250 mg each time 1 tablettime 250 mgtablet it is recommended to take orally 05 h after breakfast continuous administration Every 4 weeks is a treatment period
Treatment will continue until an event occurs that meets the criteria for treatment termination
The medication regimen for all enrolled patients was recommended as follows and the dose could be adjusted during treatment due to adverse reactions and other circumstances
Fluzopalil capsules
Oral administration of 100 mg 2 capsulestime 50 mgcapsule twice a day in the morning and evening beforeafter meals can be taken orally it is recommended to take oral administration in the morning and late 05h continuous administration Every 4 weeks is a treatment period
Apatinib tablets
Oral administration of 250 mg each time 1 tablettime 250 mgtablet it is recommended to take orally 05 h after breakfast continuous administration Every 4 weeks is a treatment period
Treatment will continue until an event occurs that meets the criteria for treatment termination
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