Ovarian CancerNCT07000344
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
A study testing Cohort 1 (triple-drug group) and Cohort 2 (dual-drug group) in people with Ovarian Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Cohort 1 (triple-drug group) and Cohort 2 (dual-drug group)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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, with international normalized ratio (INR) ≤ 1.5 ULN (not receiving anticoagulant therapy); Urinalysis: Urine protein < 2+; if urine protein ≥ 2+, then 24-hour urine protein quantification must show protein ≤ 1 g; 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) for females < 470 ms;
- The subject voluntarily agrees to participate in this study, signs the informed consent form, and is willing to comply with the follow-up requirements.
Who cannot join
- Patients allergic to the trial drug or its excipients;
- Patients with active brain metastases;
- Patients who have received systemic treatment with traditional Chinese medicine or immunomodulatory agents (including thymosin, interferon, interleukin, excluding local use for pleural effusion control) within 2 weeks prior to the first dose;
- Patients with severe cardiovascular diseases: myocardial ischemia or myocardial infarction of grade II or above, uncontrolled arrhythmias (including QTc interval ≥ 470 ms); heart function of grade III-IV (according to the New York Heart Association [NYHA] classification), or echocardiogram showing left ventricular ejection fraction (LVEF) < 50%;
- Patients with severe infections within 4 weeks prior to the first dose (e.g., requiring intravenous antibiotics, antifungals, or antivirals), or unexplained fever > 38.5℃ during the screening period or prior to the first dose; or patients who have undergone major surgical procedures within 3 weeks prior to the first dose;
- Patients with type I diabetes mellitus whose blood glucose is controlled with insulin therapy may be eligible for this study;
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- Patients undergoing systemic treatment with bronchodilators and having unsatisfactory asthma control are not eligible (patients with childhood asthma that has completely resolved and requires no intervention in adulthood may be included);
- Patients with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis B, hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the assay), or co-infection with hepatitis B and C;
- Patients who have undergone or are planned to undergo solid organ or hematopoietic stem cell transplantation during the study period (excluding corneal transplantation);
- Patients currently participating in an interventional clinical study or who have received other investigational drugs or study devices within 4 weeks prior to the first dose; patients who have not fully recovered from toxicities and/or complications caused by any prior interventions (i.e., ≤ grade 1 or returned to baseline, excluding fatigue or alopecia);
- Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg despite optimal medical therapy);
- Coagulation abnormalities (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), tendency to bleed, or receiving thrombolytic or anticoagulant therapy;
- Urinalysis showing proteinuria ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g;
- Patients with a history of allergy that may potentially cause hypersensitivity or intolerance to the trial drug or similar biologics;
- Patients with a history of substance abuse or psychiatric disorders that cannot be discontinued;
- Patients with a history of hereditary or acquired bleeding disorders or coagulopathies (eligibility to be determined by the investigator);
- Patients currently receiving strong CYP3A4 inhibitors (e.g., itraconazole, telithromycin, clarithromycin), moderate CYP3A4 inhibitors (e.g., ciprofloxacin, clarithromycin, fluconazole), strong CYP3A4 inducers (e.g., phenobarbital, enzalutamide, phenytoin, rifampin), or moderate CYP3A4 inducers (e.g., bosentan, modafinil). A washout period of 5 weeks is required for enzalutamide or phenobarbital, and 3 weeks for other drugs prior to the start of study treatment;
- Patients who have received small-molecule tyrosine kinase inhibitors (TKIs) for antiangiogenesis after achieving CR/PR with second-line platinum-based chemotherapy and using bevacizumab as maintenance therapy (patients previously treated with bevacizumab are allowed, but those treated with pazopanib, sorafenib, regorafenib, sunitinib, lenvatinib, anlotinib, etc., are not allowed);
- Patients with a history of cerebrovascular accident or transient ischemic attack within 6 months;
- Patients with other severe physical or psychiatric diseases or laboratory abnormalities that may increase the risk of participating in the study, interfere with study treatment or study results, or any other conditions deemed by the investigator as unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: A Multicenter, Open-Label, Prospective Cohort Study of Apatinib Plus Letrozole With or Without Fluzoparib as Second-Line Maintenance Therapy in ER-Positive, Platinum-Sensitive Recurrent Ovarian Cancer Following First-Line PARP Inhibitor Maintenance
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.
- Conditions
- Ovarian Cancer
- Being tested
- Cohort 1 (triple-drug group), Cohort 2 (dual-drug group)
- Keywords
- ovarian cancer, Platinum-Sensitive Recurrent, Maintenance Therapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1 (triple-drug group)Drug
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. Treatment continued until disease progression, intolerable toxicity, or other protocol-specified reasons occurred.
Cohort 2 (dual-drug group)Drug
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. Treatment continued until disease progression, intolerable toxicity, or other protocol-specified reasons occurred.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (triple-drug group) | Experimental | Patients with advanced, estrogen receptor-positive, platinum-sensitive recurrent ovarian cancer who had previously received first-line poly (ADP-ribose) polymerase (PARP) inhibitor maintenance therapy. Receives: Drug: Cohort 1 (triple-drug group) |
| Cohort 2 (dual-drug group) | Experimental | Patients with advanced, estrogen receptor-positive, platinum-sensitive recurrent ovarian cancer who had previously received first-line poly (ADP-ribose) polymerase (PARP) inhibitor maintenance therapy. Receives: Drug: Cohort 2 (dual-drug group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month progression-free survival rate
The proportion of patients who survive without disease progression (defined as any increase in tumor size or death from any cause) within 6 months from the start of the formal treatment.
Measured: 6 months
Secondary outcomes (3)
Progression-Free Survival (PFS)
Defined as the time from the start of formal treatment to the occurrence of disease progression (in any aspect) or death from any cause.
Measured: 12 months
Overall Survival (OS)
Defined as the time from the start of formal treatment to death from any cause, calculated in the intention-to-treat (ITT) population.
Measured: 24 moths
Time to First Subsequent Anti-Cancer Treatment (TFST)
The time from the start of formal treatment in the study to the initiation of the first subsequent anti-cancer treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start1 Jul 2025
- Primary completion29 Mar 2026
- Study completion30 Mar 2026
Why it stopped: Results failed to achieve the anticipated effect.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengzhi Feng, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000344
- Sponsor's protocol ID
- K7506
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Prospective Cohort Study of Apatinib Plus Letrozole With or Without Fluzoparib as Second-Line Maintenance Therapy in ER-Positive, Platinum-Sensitive Recurrent Ovarian Cancer Following First-Line PARP Inhibitor Maintenance
- ClinicalTrials.gov ID
- NCT07000344
- Acronym / sponsor ID
- K7506
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, Platinum-Sensitive Recurrent, Maintenance Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results failed to achieve the anticipated effect.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 29 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 2 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (triple-drug group) | Experimental | Drug: Cohort 1 (triple-drug group)Patients with advanced, estrogen receptor-positive, platinum-sensitive recurrent ovarian cancer who had previously received first-line poly (ADP-ribose) polymerase (PARP) inhibitor maintenance therapy. |
| Cohort 2 (dual-drug group) | Experimental | Drug: Cohort 2 (dual-drug group)Patients with advanced, estrogen receptor-positive, platinum-sensitive recurrent ovarian cancer who had previously received first-line poly (ADP-ribose) polymerase (PARP) inhibitor maintenance therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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);
Key exclusion criteria (20 listed)
- Patients allergic to the trial drug or its excipients;
- Patients with active brain metastases;
- Patients who have received systemic treatment with traditional Chinese medicine or immunomodulatory agents (including thymosin, interferon, interleukin, excluding local use for pleural effusion control) within 2 weeks prior to the first dose;
- Patients with severe cardiovascular diseases: myocardial ischemia or myocardial infarction of grade II or above, uncontrolled arrhythmias (including QTc interval ≥ 470 ms); heart function of grade III-IV (according to the New York Heart Association [NYHA] classification), or echocardiogram showing left ventricular ejection fraction (LVEF) < 50%;
- Patients with severe infections within 4 weeks prior to the first dose (e.g., requiring intravenous antibiotics, antifungals, or antivirals), or unexplained fever > 38.5℃ during the screening period or prior to the first dose; or patients who have undergone major surgical procedures within 3 weeks prior to the first dose;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1 (triple-drug group)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. Treatment continued until disease progression, intolerable toxicity, or other protocol-specified reasons occurred. | Drug | Cohort 1 (triple-drug group) |
| Cohort 2 (dual-drug group)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. Treatment continued until disease progression, intolerable toxicity, or other protocol-specified reasons occurred. | Drug | Cohort 2 (dual-drug group) |
Primary outcome
6-month progression-free survival rate
Time frame: 6 months
The proportion of patients who survive without disease progression (defined as any increase in tumor size or death from any cause) within 6 months from the start of the formal treatment.
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 12 months
Overall Survival (OS)
Time frame: 24 moths
Time to First Subsequent Anti-Cancer Treatment (TFST)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Results failed to achieve the anticipated effect.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cohort 1 (triple-drug group) and Cohort 2 (dual-drug group) in people with Ovarian Cancer, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Results failed to achieve the anticipated effect.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month progression-free survival rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.