The Efficacy and Safety of Fluzopril Combined With Apatinib in Maintenance Treatment of Platinum Resistant Recurrent Ovarian Cancer Patients

NCT06102707 | Not Yet Recruiting

• 1 other identifier: KYLL-202210-045
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Disease progression free survival

  Disease progression free survival (PFS) evaluated by researchers based on RECIST 1.1 criteria

  36 months

Study Arms (1)

Fluzopril Combined With Apatinib Group

EXPERIMENTAL

Drug: Fluzopril Combined With Apatinib

Interventions

Fluzopril Combined With Apatinib DRUG

Fluzopril Capsules 100mg po bid Apatinib Mesylate Tablets 250mg po qd

Fluzopril Combined With Apatinib Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Interventions

apatinib

Central Study Contacts

Bu Huelei

CONTACT

0086-0531-82169035; buhualei@email.sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 26, 2023

Record last verified: 2023-10