Ovarian Cancer RecurrentNCT06102707
The Efficacy and Safety of Fluzopril Combined With Apatinib in Maintenance Treatment of Platinum Resistant Recurrent Ovarian Cancer Patients
A study testing Fluzopril Combined With Apatinib in people with Ovarian Cancer Recurrent, run by Qilu Hospital of Shandong University.
Trial summary
Ovarian cancer is the most lethal gynecological malignancy, posing a serious threat to women's health worldwide.Platinum resistant ovarian cancer is the biggest challenge faced by gynecological oncologists.Exploring more effective treatment options and how to delay the recurrence of platinum resistant recurrent… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer Recurrent
- What is being tested?
- Fluzopril Combined With Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Nov 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
- The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
- Female, age ≥ 18 years old (calculated based on the date of signing informed consent).
- High grade (or medium to low differentiation) serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer confirmed by pathology; Or moderately or poorly differentiated ovarian endometrioid adenocarcinoma. Disease progression occurred within 6 months (182 days) of the last platinum containing chemotherapy.
- Received at least 3 cycles of chemotherapy.
- After the completion of chemotherapy treatment, it is evaluated as non disease progression and must be randomly enrolled within 6 weeks after the last dose of chemotherapy is administered.
- Must be able to provide tumor tissue samples fixed with formalin and embedded in paraffin (FFPE).
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- The Eastern Cooperative Oncology Group score is 0-1.
- The function of important organs meets the following requirements (no blood components or cell growth factors are allowed to be used within the first 14 days of randomization):absolute neutrophil count ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Hemoglobin ≥ 90g/L;Serum albumin ≥ 3g/dL;Bilirubin ≤ 1.5 times ULN;ALT and AST ≤ 3 times ULN; Serum creatinine ≤ 1.5 times ULN.
- Patients with potential fertility need to use at least one medically approved contraceptive method (such as an intrauterine device or condom) during the study treatment period and within 3 months after the end of the study treatment period, and must have a negative serum HCG test within 72 hours before randomization; And it must be non lactating.
Who cannot join
- Subjects had other malignant tumors in the past (within 5 years) or at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ and breast cancer that had no recurrence for more than 3 years after the completion of radical surgery.
- Previously used both PARP inhibitors and small molecule VEGF inhibitors, including but not limited to olaparib, nilaparib, arotinib, apatinib, etc; Single drug treatment can be included in the group.
- Patients with untreated central nervous system metastasis who have previously received systemic or curative brain or meningeal metastasis treatment (radiotherapy or surgery), and have been confirmed stable by imaging for at least 1 month, and have stopped systemic hormone therapy (dosage>10mg/day of prednisone or other effective hormones) for more than 2 weeks, without clinical evidence, can be included.
- Patients who have recently experienced intestinal obstruction or gastrointestinal perforation (within 3 months).
- Patients who are unable to swallow tablets normally or have gastrointestinal dysfunction, as determined by the researchers, may affect drug absorption.
- Patients with clinical symptoms of cancerous ascites or pleural effusion who require puncture or drainage, or who have received ascites or pleural effusion drainage within the first 3 months of randomization.
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- Patients with clinically uncontrolled cardiac symptoms or diseases, such as NYHA grade 2 or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, and QTc>470ms.
- Patients with hypertension who cannot achieve good control after treatment with antihypertensive drugs (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg).
- Any bleeding event with a severity rating of 2 or above in CTCAE 5.0 within the first 4 weeks of randomization.
- Previous or current history of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, tissue pneumonia (such as bronchitis, occlusive vasculitis), drug-induced pneumonia, or screening stage CT showing active pneumonia.
- Individuals with abnormal coagulation function (INR>1.5 or prothrombin time>ULN+4 seconds), bleeding tendencies, or undergoing thrombolytic or anticoagulant treatment are allowed to receive low-dose low-molecular-weight heparin or oral aspirin for prophylactic anticoagulant treatment during the trial period.
- There have been incidents of arterial/venous thrombosis within the first 6 months of randomization, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, and pulmonary embolism.
- Patients with a history of hereditary or acquired hemorrhagic disease or coagulation disorders. Within the first 3 months of randomization, there were significant clinically significant bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, etc.
- Subject has active infection or unexplained onset of ≥ 38.5 ° C within 7 days prior to randomization.
- Subjects have congenital or acquired immune deficiency (such as HIV infected persons), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥ 500IU/ml; hepatitis C reference: HCV antibody positive and HCV copy number>upper limit of normal value).
- Patients who have received surgery, radiation therapy, chemotherapy, and endocrine therapy before randomization for less than 4 weeks after treatment completion; Adverse events caused by previous treatment (excluding hair loss) that have not recovered to ≤ 1 level (CTCAE 5.0).
- Patientss who may receive other systemic anti-tumor treatments or plan to undergo ovarian cancer reduction surgery during the study period.
- According to the judgment of the researchers, there are other factors that may lead to the forced termination of this study, such as other serious illnesses (including mental illness) requiring concurrent treatment, serious laboratory test abnormalities, accompanied by family or social factors, which may affect the safety of the subjects, or the collection of data and samples.
Trial locations and contacts
No sites are listed yet.
About this study
Ovarian cancer is the most lethal gynecological malignancy, posing a serious threat to women's health worldwide.Platinum resistant ovarian cancer is the biggest challenge faced by gynecological oncologists.Exploring more effective treatment options and how to delay the recurrence of platinum resistant recurrent ovarian cancer remains a challenging issue in clinical treatment.The main goal of this trial is to evaluate the effectiveness and safety of fluzopril combined with apatinib in maintenance treatment of platinum resistant recurrent ovarian cancer patients by evaluating progression free survival (PFS).Fifty patients with advanced ovarian cancer who underwent platinum resistant recurrent chemotherapy and assessed no disease progression were enrolled in the study, and maintenance treatment was performed with fluzopril combined with apatinib.
- Conditions
- Ovarian Cancer Recurrent
- Being tested
- Fluzopril Combined With Apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzopril Combined With ApatinibDrug
Fluzopril Capsules 100mg po bid Apatinib Mesylate Tablets 250mg po qd
| Study group | Role | What they receive |
|---|---|---|
| Fluzopril Combined With Apatinib Group | Experimental | Not described Receives: Drug: Fluzopril Combined With Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression free survival
Disease progression free survival (PFS) evaluated by researchers based on RECIST 1.1 criteria
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102707
- Sponsor's protocol ID
- KYLL-202210-045
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Fluzopril Combined With Apatinib in Maintenance Treatment of Platinum Resistant Recurrent Ovarian Cancer Patients
- ClinicalTrials.gov ID
- NCT06102707
- Acronym / sponsor ID
- KYLL-202210-045
- Conditions
- Ovarian Cancer Recurrent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 26 Oct 2023 (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.
Ovarian cancer is the most lethal gynecological malignancy, posing a serious threat to women's health worldwide.Platinum resistant ovarian cancer is the biggest challenge faced by gynecological oncologists.Exploring more effective treatment options and how to delay the recurrence of platinum resistant recurrent ovarian cancer remains a challenging issue in clinical treatment.The main goal of this trial is to evaluate the effectiveness and safety of fluzopril combined with apatinib in maintenance treatment of platinum resistant recurrent ovarian cancer patients by evaluating progression free survival (PFS).Fifty patients with advanced ovarian cancer who underwent platinum resistant recurrent chemotherapy and assessed no disease progression were enrolled in the study, and maintenance treatment was performed with fluzopril combined with apatinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluzopril Combined With Apatinib Group | Experimental | Drug: Fluzopril Combined With Apatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
- Female, age ≥ 18 years old (calculated based on the date of signing informed consent).
- High grade (or medium to low differentiation) serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer confirmed by pathology; Or moderately or poorly differentiated ovarian endometrioid adenocarcinoma. Disease progression occurred within 6 months (182 days) of the last platinum containing chemotherapy.
- Received at least 3 cycles of chemotherapy.
- After the completion of chemotherapy treatment, it is evaluated as non disease progression and must be randomly enrolled within 6 weeks after the last dose of chemotherapy is administered.
Key exclusion criteria (18 listed)
- Subjects had other malignant tumors in the past (within 5 years) or at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ and breast cancer that had no recurrence for more than 3 years after the completion of radical surgery.
- Previously used both PARP inhibitors and small molecule VEGF inhibitors, including but not limited to olaparib, nilaparib, arotinib, apatinib, etc; Single drug treatment can be included in the group.
- Patients with untreated central nervous system metastasis who have previously received systemic or curative brain or meningeal metastasis treatment (radiotherapy or surgery), and have been confirmed stable by imaging for at least 1 month, and have stopped systemic hormone therapy (dosage>10mg/day of prednisone or other effective hormones) for more than 2 weeks, without clinical evidence, can be included.
- Patients who have recently experienced intestinal obstruction or gastrointestinal perforation (within 3 months).
- Patients who are unable to swallow tablets normally or have gastrointestinal dysfunction, as determined by the researchers, may affect drug absorption.
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 |
|---|---|---|
| Fluzopril Combined With ApatinibFluzopril Capsules 100mg po bid Apatinib Mesylate Tablets 250mg po qd | Drug | Fluzopril Combined With Apatinib Group |
Primary outcome
Disease progression free survival
Time frame: 36 months
Disease progression free survival (PFS) evaluated by researchers based on RECIST 1.1 criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Fluzopril Combined With Apatinib in people with Ovarian Cancer Recurrent, run by Qilu Hospital of Shandong University.
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 9 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bu Huelei (0086-0531-82169035, buhualei@email.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease progression free survival (time frame: 36 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 26 Oct 2023.