Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-26 @ 5:44 AM
Study NCT ID:
NCT05669768
Status:
UNKNOWN
Last Update Posted:
2023-01-03
First Post:
2022-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Efficacy and Toxicity of Pamiparib Combined With Tamoxifen in the Treatment of Epithelial Ovarian Cancer Patients With Biochemical Recurrence During First-line PARPi Maintenance Therapy
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Study on the Efficacy and Toxicity of Pamiparib Combined With Tamoxifen in the Treatment of Epithelial Ovarian Cancer Patients With Biochemical Recurrence During First-line PARPi Maintenance Therapy
Status:
UNKNOWN
Status Verified Date:
2022-12
Last Known Status:
NOT_YET_RECRUITING
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 phase II single arm prospective clinical study is to evaluate the efficacy and toxicity of pamiparib + tamoxifen regimen in epithelial ovarian cancer patients with biochemical recurrence during first-line PARPi maintenance therapy. The main questions it aims to answer are:
* Effect of the regimen on the reduction of CA125
* The delayed effect of treatment regimens on the patient's radiographic progression
* Effect of the regimen on the reduction of CA125
* The delayed effect of treatment regimens on the patient's radiographic progression
Detailed Description:
A high proportion of ovarian cancer patients tend to have elevated CA-125 2-6 months before imaging recurrence. The time between biochemical recurrence (i.e., only elevated CA125 without imaging to assess lesions or clinical symptoms) to imaging recurrence can be considered a "window period", and if imaging progression can be delayed after biochemical recurrence, the chemotherapy interval can be extended, converting platinum-resistant relapsed patients to platinum-sensitive patients, and ultimately improving patient outcomes.
The timing of treatment for these patients has been controversial, and international guidelines recommend some management approaches: 1) Follow-up observation; 2) Use of tamoxifen or other hormonal drugs; 3) Immediately administer chemotherapy according to the recurrent tumor; 4) Participate in clinical trials.
Pamiparib is a new PARPi that has shown good efficacy and safety in the posterior-line treatment of ovarian cancer patients, this study used tamoxifen combined with pamiparib to explore the efficacy and toxic side effects of this regimen in epithelial ovarian cancer patients with biochemical recurrence during first-line PARPi maintenance therapy.
The timing of treatment for these patients has been controversial, and international guidelines recommend some management approaches: 1) Follow-up observation; 2) Use of tamoxifen or other hormonal drugs; 3) Immediately administer chemotherapy according to the recurrent tumor; 4) Participate in clinical trials.
Pamiparib is a new PARPi that has shown good efficacy and safety in the posterior-line treatment of ovarian cancer patients, this study used tamoxifen combined with pamiparib to explore the efficacy and toxic side effects of this regimen in epithelial ovarian cancer patients with biochemical recurrence during first-line PARPi maintenance therapy.
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?: