A Study of Apatinib Combined With Letrozole With or Without Fluzoparib in Estrogen Receptor-Posit… (NCT07000344) | Clinical Trial Compass
TerminatedNot Applicable
A Study of Apatinib Combined With Letrozole With or Without Fluzoparib in Estrogen Receptor-Positive, Platinum-Sensitive Recurrent Ovarian Cancer Previously Treated With First-Line PARP Inhibitor
Stopped: Results failed to achieve the anticipated effect.
China5 participantsStarted 2025-07-01
Plain-language summary
This multicenter, open-label, prospective cohort clinical study enrolled 70 patients with late-stage ER（+）platinum-sensitive recurrent ovarian cancer who had achieved CR/PR after first-line PARP inhibitor maintenance therapy. The study was divided into two cohorts, with 35 participants in each. Cohort 1 (triple-drug group) received the following treatments: Apatinib: 250 mg orally once daily, with a 28-day treatment cycle. Fluzoparib: 100 mg orally twice daily, with a 4-week continuous treatment cycle. Letrozole: 2.5 mg orally once daily, with a 4-week continuous treatment cycle.
Cohort 2 (dual-drug group) received: Apatinib: 250 mg orally once daily, with a 28-day treatment cycle. Letrozole: 2.5 mg orally once daily, with a 4-week continuous treatment cycle. reatment continued until disease progression, intolerable toxicity, or other protocol-specified reasons occurred.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years;
* ECOG Performance Status score of 0 or 1;
* Epithelial ovarian cancer with platinum-sensitive recurrence (no restriction on histological type);
* Patients who have received first-line maintenance treatment with olaparib or niraparib (including but not limited to) and achieved complete response (CR) or partial response (PR) to second-line platinum-based chemotherapy;
* Availability of genetic testing results (BRCA1/2) and estrogen receptor (ER) testing results (ER positivity is defined as ≥ 1% of tumor cells staining positive for ER);
* Estimated survival of ≥ 6 months;
* Good function of major organs in the subject, with relevant test results meeting the following requirements within 7 days prior to enrollment:
Hematological tests (no blood transfusion or use of hematopoietic growth factors within 7 days prior to screening):
Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; Platelet count (PLT) ≥ 100×10⁹/L; White blood cell count (WBC) ≥ 3.0×10⁹/L and ≤ 15×10⁹/L;
Biochemical tests (no blood transfusion or albumin within 7 days prior to screening):
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN); Alkaline phosphatase (ALP) ≤ 2.5 ULN; Total bilirubin (TBIL) ≤ 1.5 ULN; Serum creatinine (Cr) ≤ 1.5 ULN, with creatinine clearance (CrCL) ≥ 60 mL/min (Cockcroft-Gault formula); Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 ULN,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.