Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437353
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-26
Brief Title:
Surufatinib Combined With CarboplatinPaclitaxel and Surufatinib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer
Sponsor:
Anhui Provincial Cancer Hospital
Organization:
Anhui Provincial Cancer Hospital
Study Overview
Official Title:
Sorafenib Combined With CarboplatinPaclitaxel and Sorafenib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer a Single-arm Multicenter Exploratory Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-08
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 goal of this type of clinical trial study is to evaluate the safety and efficacy of Surufatinib combined with CarboplatinPaclitaxel and Surufatinib combined with Olaparib as first-line and maintenance therapy for newly diagnosed high-risk ovarian cancer
Detailed Description:
Patients will have tests and exams to see if they are eligible for the clinical trial
First-line chemotherapy regimen
PaclitaxelCarboplatinrepeat every 3 weeks total of 6 cycles
Paclitaxel 175 mgm² intravenous infusion on day 1
Carboplatin AUC 5 intravenous infusion on day 1
For patients aged 70 years or those with comorbidities the paclitaxel dose can be adjusted to 135 mgm²
Surufatinibrepeat every 3 weeks total of 5 cycles
Surufatinib is not used during the first postoperative cycle
Starting from the second postoperative cycle surufatinib is administered at a dose of 250 mg once daily taken continuously
Maintenance Therapy Regimen
HRD-positive Patients
Surufatinib 250 mg once daily taken continuously
Olaparib 300 mg twice daily with doses taken 12 hours apart Olaparib can be used for a maximum of 2 years
HRD-negative or HRD Status Unknown Patients
Surufatinib 250 mg once daily taken continuously
Treatment continues until the patient experiences disease progression or meets other criteria for discontinuation of the study treatment as specified in the protocol
First-line chemotherapy regimen
PaclitaxelCarboplatinrepeat every 3 weeks total of 6 cycles
Paclitaxel 175 mgm² intravenous infusion on day 1
Carboplatin AUC 5 intravenous infusion on day 1
For patients aged 70 years or those with comorbidities the paclitaxel dose can be adjusted to 135 mgm²
Surufatinibrepeat every 3 weeks total of 5 cycles
Surufatinib is not used during the first postoperative cycle
Starting from the second postoperative cycle surufatinib is administered at a dose of 250 mg once daily taken continuously
Maintenance Therapy Regimen
HRD-positive Patients
Surufatinib 250 mg once daily taken continuously
Olaparib 300 mg twice daily with doses taken 12 hours apart Olaparib can be used for a maximum of 2 years
HRD-negative or HRD Status Unknown Patients
Surufatinib 250 mg once daily taken continuously
Treatment continues until the patient experiences disease progression or meets other criteria for discontinuation of the study treatment as specified in the protocol
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