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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Pamiparib 40mg PO BID, Tamoxifen 20mg PO BID
Sun Yat-sen University Cancer Centre
Guangzhou, Guangdong, China
Response rate by CA-125
Best overall response in patients without initial measurable disease and who are evaluable by CA 125 is according to the Gynecological Cancer Intergroup (GCIG)
Time frame: Up to approximately 24 months
PFS (progression-free survival)
PFS of parmiparib in combination with tamoxifen in epithelial ovarian cancer patients with biochemical recurrence during first-line PARPi maintenance therapy was assessed by investigators according to RECIST v1.1
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
TFST (Time to first subsequent therapy)
TFST of parmiparib in combination with tamoxifen in epithelial ovarian cancer patients with biochemical recurrence during first-line PARPi maintenance therapy was assessed by investigators according to the time when the patients started subsequent treatment
Time frame: TFST was defined as the time from the onset of patient enrollment to the time of first subsequent treatment or death, whichever occurs first, up to 24 months.
The percentage of subjects discontinued study treatment due to adverse events assessed according to NCI-CTCAE v5.0.
Safety and tolerability
Time frame: Up to approximately 24 months
EORTC-QLQ-C30(EORTC Core Quality of Life questionnaire)
The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire assesses important functioning domains (e.g. physical, emotional, role) and common cancer symptoms (e.g. fatigue, pain, nausea/vomiting, appetite loss). The EORTC QLQ-C30 was scored according to the scoring manual. This produced scores on 15 subscales (range for each, 0-100), with higher scores indicating better outcomes on global quality of life/health and functioning subscales and worse outcomes on symptom scales and for financial problems.
Time frame: Up to approximately 24 months
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