[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-ovarian-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-ovarian-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,71,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100445447","phase-2-adaptive-chemotherapy-for-ovarian-cancer-in-patients-with-replased-platinum-sensitive-high-grade-serous-or-high-grade-endometrioid-ovarian-cancer-100445447",false,"NCT05080556","Adaptive ChemoTherapy for Ovarian Cancer in Patients With Replased Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer","A Multicentre Phase II Randomised Controlled Trial to Evaluate the Efficacy of Adaptive Therapy (AT) With Carboplatin, Based on Changes in CA125, in Patients With Relapsed Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer","ACTOv","Inclusion Criteria:\n\n1. Female patients aged ≥18 years\n2. ECOG performance status 0-2\n3. Histologically proven diagnosis of high grade serous or high grade endometrioid carcinoma of the ovary, fallopian tube or peritoneum\n4. Most recent regimen must have included platinum (cisplatin or carboplatin)\n5. Must have previously received a PARP inhibitor\n6. 6\\. Must have responded to most recent platinum treatment by CT or MRI or by GCIG CA125 response criteria\n7. Pre-trial CT or MRI-confirmed disease relapse ≥ 6 months after day 1 of the last cycle of platinum-containing chemotherapy (cisplatin or carboplatin) and requiring treatment with further platinum-based chemotherapy\n8. Measurable disease by RECIST v1.1 on a CT scan conducted within 28 days prior to randomisation (Patient with non-measurable disease could be eligible if they meet GCIG CA125 progression criteria)\n9. CA125 ≥ 100iU\u002Fl at screening\n10. Agree to provide additional research blood samples at the same time as blood draws prior to each carboplatin treatment, 6-weekly during surveillance and at 12- weekly follow-up visit\n11. Expected to be able to commence treatment within 28 days post randomisation\n12. Adequate bone marrow function\n13. Adequate liver function\n14. Adequate renal function\n15. Postmenopausal or women of child-bearing potential (WOCBP) must agree to have an urine or serum pregnancy test at screening for evidence of non-childbearing status and prior to trial treatment and use adequate contraception for duration of trial\n16. Willing and able to give consent and able to comply with treatment and follow up schedule\n\nExclusion Criteria:\n\n1. Non-epithelial ovarian cancer, carcinosarcoma, low-grade serous and endometrioid carcinomas, mucinous \\& clear-cell carcinomas\n2. Patients requiring treatment with combination chemotherapy regimens\n3. Patients with a known hypersensitivity to carboplatin\n4. Persisting ≥ grade 2 CTCAE v5 adverse events\u002F toxicity (except alopecia and neuropathy) from previous anti-cancer treatment.\n5. Treatment with any other investigational agent, or participation in another interventional clinical trial within 28 days prior to randomisation.\n6. Major surgery within 14 days before anticipated start of treatment and patients must have recovered from any effects of major surgery.\n7. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicated the use of an investigation drug or puts the patients at high risk for treatment-related complications.\n8. Other psychological, psychiatric, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.\n9. Malignancy treated within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, Stage 1, grade 1 endometrial carcinoma.\n10. Patients with symptomatic uncontrolled brain or meningeal metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.\n11. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days prior to randomisation.\n12. Pregnant or breast-feeding women are excluded. Women of childbearing potential will be excluded unless effective methods of contraception are used from signing of the informed consent, throughout the period of taking study treatment and for at least 6 months after last dose of trial drug(s).\n13. Inability to attend or comply with treatment or follow-up scheduling.","FEMALE","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","ACTOv will compare standard 3-weekly carboplatin (AUC5), to carboplatin delivered according to an AT regimen. The AT regimen will modify carboplatin dose according to changes in the clinical-standard serum biomarker CA125 as a proxy measure of total tumour burden and an individual patient's response to the most recent chemotherapy treatment. AT could prolong sensitivity to carboplatin and extend tumour control, while simultaneously reducing chemotherapy dose and drug-induced toxicity. Carboplatin is a low cost and low toxicity drug that has an enduring and central role in ovarian cancer treatment.",[27,28,29,30,31,32,33],"Ovarian Cancer","Relapsed Ovarian Cancer","Fallopian Tube Cancer","Peritoneal Cancer","Endometrioid Carcinoma","High Grade Serous Carcinoma","Ovary Cancer","RECRUITING","2024-04-11",{"date":37,"type":38},"2024-04-12","ACTUAL",{"date":40,"type":38},"2023-05-24",{"date":42,"type":21},"2027-11-01",{"name":44,"class":45},"University College, London","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100522359","phase-2-fluzoparib-combined-with-apatinib-in-relapsed-ovarian-carcinoma-maintenance-treatment-100522359","NCT06081595","Fluzoparib Combined With Apatinib in Relapsed Ovarian Carcinoma Maintenance Treatment","Fluzoparib Combined With Apatinib for Maintenance Treatment in Platinum-Sensitive Relapsed Ovarian Carcinoma: A Phase II Single-arm, Open Label, Multicenter Trial","Inclusion Criteria:\n\n* The patient voluntarily joined the study and signed the informed consent.\n* Age 18-75 years old.\n* Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; Or moderately or poorly differentiated ovarian endometrioid adenocarcinoma.\n* Previously, after undergoing 2-3 lines of platinum containing chemotherapy, CR or PR was achieved, and the time from the penultimate platinum containing chemotherapy to PD was ≥ 6 months.\n* Patients who have received previous treatment with bevacizumab are acceptable.\n* Allow previous treatment with PARP inhibitors other than Fluzoparib.\n* ECOG score: 0-1.\n* Participant has adequate organ function as defined in the following contents (Any blood component or cell growth factor within 14 days prior to randomization is not permitted) Absolute neutrophil count (ANC) ≥1.5×109\u002FL Platelets ≥100×109\u002FL Hemoglobin ≥10g\u002FdL Serum albumin ≥3g\u002FdL Total bilirubin ≤1.5 ×ULN AST (SGOT) and ALT (SGPT) ≤3 × ULN Serum creatinine ≤1.5 × ULN\n* Patients with potential fertility need to use a medically approved contraceptive (such as an intrauterine device, birth control pill or condom) during he study treatment period and within 2 months after the last administration of apatinib or 6 months after the last administration of fluzopril, whichever is longer; Serum HCG or urine HCG must be negative within 72 hours prior to study enrollment; must be a non-lactation period.\n\nExclusion Criteria:\n\n* Previous (within 5 years) or concurrent with other uncured malignant tumors, except for cured skin basal cell carcinoma, thyroid cancer, cervical carcinoma in situ and breast cancer with no recurrence \\>3 years after radical surgery.\n* The subject has untreated central nervous system metastasis.\n* Inability to swallow pills normally, or gastrointestinal dysfunction, which may affect drug absorption according to the researchers.\n* Recent (within 3 months) occurrence of intestinal obstruction.\n* Patients with clinical symptoms of cancerous ascites and pleural effusion, who need puncture or drainage, or who have received ascites and pleural effusion drainage within 2 months before the first trial medication.\n* Patients with poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc\\>470ms.\n* Those with abnormal coagulation function (INR \\> 1.5 or prothrombin time (PT) \\> ULN+4 seconds), who have a bleeding tendency or are receiving thrombolytic or anticoagulant therapy, are allowed to receive low-dose low-molecular weight heparin or oral aspirin prophylactic anticoagulant therapy during the trial.\n* The subject has an active infection or unexplained fever \\>38.5 degrees during the screening period and before the first dose;\n* Subjects with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥500 IU\u002Fml; Hepatitis C reference: HCV antibody positive and HCV copy number \\> upper limit of normal).\n* Those who had previously received radiotherapy, chemotherapy, endocrine therapy, or molecular targeted therapy and were enrolled less than 4 weeks after the completion of treatment (last dose); Adverse events (except alopecia) caused by previous treatment did not recover to ≤1 degree (CTCAE 5.0).\n* Patients who have used other drugs in clinical trial studies within the previous 4 weeks.\n* Subjects may receive other systemic anti-tumor therapies during the study period.\n* known allergy to Fluzoparib, apatinib and its excipients.\n* In the investigator's judgment, the subjects have other factors that may lead to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring combined treatment, serious laboratory abnormalities, family or social factors that may affect the safety of the subjects, or the collection of data and samples.","ALL","75 Years",{"count":57,"type":21},54,[24],"This study is a Phase II single-arm, open label, multicenter study to access the effects and tolerability of fluzoparib combined with apatinib for maintenance treatment in platinum-sensitive relapsed ovarian carcinoma .",[28],"NOT_YET_RECRUITING","2023-10-07",{"date":64,"type":38},"2023-10-13",{"date":66,"type":21},"2023-10-30",{"date":68,"type":21},"2026-12-30",{"name":70,"class":45},"Jin Li",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":46},"100485919","secondary-cytoreduction-followed-by-chemotherapy-versus-chemotherapy-alone-in-relapsed-ovarian-cancer-after-parpi-maintenance-treatment-a-multicentre-open-label-randomised-phase-3-trial-100485919","NCT05607329","Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicentre, Open-label, Randomised, Phase 3 Trial","Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicenter, Open-label, Randomized, Phase 3 Trial","Inclusion Criteria:\n\n1. Patients with diagnosis of first-line or second-line recurrent epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma, who has previously received at least 4 cycles of platinum-based chemotherapy in initial treatment;\n2. Relapse occurred after 6 month since platinum-based chemotherapy;\n3. PARPi maintenance therapy for more than 6 months before relapse;\n4. R0 ideal debulking in initial surgery;\n5. PET-CT indicate the recurrence lesion is isolated and not exceed 5 sites, and the ascites is less than 500ml;\n6. ECOG\u002FWHO Performance score of 0 to 1;\n7. No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit\n8. No Renal insufficiency (serum creatinine \\\u003C 1,5 time the normal limit, creatinine clearance \\> 80 mL\u002Fmin). calculated with MDRD method\n9. Hematology function: PNN ≥ 1,5x10⁹\u002FL, platelets ≥ 100x10⁹\u002FL\n10. No contraindication to general anaesthesia for heavy surgery\n11. Patients having read, signed and dated Informed consent before any study procedure\n\nExclusion Criteria:\n\n1. Platinum-refractory\u002Funcontrolled epithelial ovarian cancer;\n2. Non-epithelial ovarian tumor, mucinous, serous-mucinous (mainly mucinous), malignant Brenner tumor, low-grade serous carcinoma, borderline tumor;\n3. Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;\n4. Received radiotherapy within 2 weeks before the start of the study intervention;\n5. General conditions cannot tolerate secondary cytoreduction;\n6. Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and\u002For any of its excipients.","70 Years",{"count":80,"type":21},400,[82],"NA","This study aims to carry out a multi-center, randomized controlled study on patients with recurrent ovarian cancer after PARPi maintenance, to explore the clinicopathological and molecular characteristics of patients with recurrent ovarian cancer after PARPi maintenance, and to clarify whether patients with recurrent ovarian cancer after PARPi maintenance for more than 6 months are sensitive to platinum drugs, and the value of secondary tumor cell reduction in such treatment, In order to provide evidence-based medicine basis for the standardized treatment mode of recurrent ovarian cancer after PARPi maintenance treatment.",[28],"2022-11-04",{"date":87,"type":38},"2022-11-07",{"date":89,"type":38},"2021-05-01",{"date":91,"type":21},"2028-05-01",{"name":93,"class":45},"Women's Hospital School Of Medicine Zhejiang University",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100476096","phase-2-fluzoparib-and-apatinib-versus-fluzoparib-in-relapsed-ovarian-carcinoma-maintenance-treatment-100476096","NCT05479487","Fluzoparib and Apatinib Versus Fluzoparib in Relapsed Ovarian Carcinoma Maintenance Treatment","Fluzoparib Combined With Apatinib Versus Fluzoparib for Maintenance Treatment in Platinum-Sensitive Relapsed Ovarian Carcinoma: A Randomized, Open Label, Controlled, Multicenter Trial","Inclusion Criteria:\n\n1. The patient voluntarily joined the study and signed the informed consent\n2. Patients ≥18 years of age.\n3. Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; ≥grade II ovarian endometrioid adenocarcinoma.\n\n   * Mixed mullerian: contain high-grade serous component or endometrioid components over 50%.\n4. Participant has received 2 or 3 previous lines of platinum-containing therapy and the last chemotherapy course contains platinum regimen.\n\n   * Preoperative neoadjuvant chemotherapy and postoperative chemotherapy were considered as 1 line chemotherapy treatment.\n5. Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months (184 days) after completion of their last dose of platinum chemotherapy\n6. Participant has responded to last the platinum regimen (complete or partial response), remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen.\n\n   * The last chemotherapy must be a platinum-based chemotherapy regimen.\n   * Patient must have received at least 4 cycles of treatment for the last platinum-based chemotherapy.\n   * A detectable lesion or CA-125 ≥2 ×ULN is required before the last platinum treatment\n   * The imaging results showed CR or PR during the last platinum-containing regimen. CA125 decreased to within the ULN or ≥90% from pre-treatment level during treatment and CA125 remained \\\u003C1xULN or did not increase by \\>10% in 7 days before the first treatment.\n   * If no lesion is assessed prior to chemotherapy, CA125 should be alleviated to the ULN during treatment and maintained at \\\u003C1xULN for 7 days prior to the first treatment.\n7. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to enrollment.\n8. Participant had prior treatment with PARP inhibitor in a maintenance setting:\n\n   * For the BRCA1\u002F2 cohort, the duration of first PARPi exposure must have been ≥18 months following a first line of chemotherapy or ≥12 months following a second line of chemotherapy.\n   * For the non BRCA1\u002F2 cohort, the duration of first PARPi exposure must have been ≥12 months following a first line of chemotherapy or ≥6 months following a second line of chemotherapy.\n9. Participant has adequate organ function as defined in the following contents (Any blood component or cell growth factor within 14 days prior to randomization is not permitted) Absolute neutrophil count (ANC) ≥1.5×109\u002FL Platelets ≥100×109\u002FL Hemoglobin ≥10g\u002FdL Serum albumin ≥3g\u002FdL Total bilirubin ≤1.5 ×ULN AST (SGOT) and ALT (SGPT) ≤3 × ULN Serum creatinine ≤1.5 × ULN\n10. Patients with potential fertility need to use a medically approved contraceptive (such as an intrauterine device, birth control pill or condom) during and for 3 months after the study period; Serum HCG or urine HCG must be negative within 72 hours prior to study enrollment; must be a non-lactation period.\n\nExclusion Criteria:\n\n1. Prior malignancy unless curatively treated and disease-free for \\> 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix or breast cancer without recurrence over 3 years allowed.\n2. Untreated and\u002For uncontrolled brain metastases.\n3. Not able to swallow pills normally, or have abnormal gastrointestinal function affecting drug absorption as judged by the researcher.\n4. Intestinal obstruction within 3 months.\n5. The urine protein ≥ ++ and 24-hour urine protein level \\> 1.0g.\n6. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 3 months prior to the first administration;\n7. Uncontrolled heart clinical symptoms or diseases, such as :(1) NYHA 2 or more heart failure, (2) Unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Ventricular arrhythmias requiring intervention, (5) QTc\\>470ms.\n8. Abnormal coagulation function (INR \\> 1.5 or prothrombin time (PT) \\> ULN+4 seconds), bleeding tendency or receiving thrombolytic therapy are allowed to receive low-dose low-molecular weight heparin or oral aspirin preventive anticoagulant therapy during the study.\n9. Significant bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc., within the first 3 months of the randomization. If fecal occultation blood is positive at baseline, gastroscopy should be performed if still positive after reexamination.\n10. Active ulcers, unhealed wounds or fractures.\n11. Uncontrolled hypertension by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg).\n12. Any bleeding event with grade 2 or higher in CTCAE 5.0 within 4 weeks prior randomization.\n13. Active infection or unexplained fever \\>38.5 degrees during screening or before first treatment.\n14. Known to be human immunodeficiency virus positive; Known active hepatitis C virus, or known active hepatitis B virus.\n15. Received radiotherapy, chemotherapy, hormone therapy, or molecular targeted therapy, less than 4 weeks after the completion of the last dose or less than 5 drug half-lives before the study for oral molecular targeted drug; Adverse events caused by previous treatment (except hair loss) and not recover to ≤1 degree (CTCAE 5.0).\n16. Arteriovenous thrombosis events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. occurred within 6 months.\n17. History of hereditary or acquired bleeding or coagulation disorders (e.g., hemophilia, coagulopathy, thrombocytopenia, etc.).\n18. Need receive other systemic anti-tumor therapy during the study period.\n19. Other factors that may cause the study to be terminated.",{"count":102,"type":21},132,[24],"This study is a Phase II randomized, open label, controlled, multicenter study to access the effects and tolerability of fluzoparib combined with apatinib versus fluzoparib monotherapy for maintenance treatment in platinum-sensitive relapsed ovarian carcinoma (including patients previous treated with a PARP inhibitor).",[28],"2022-07-27",{"date":108,"type":38},"2022-07-29",{"date":110,"type":21},"2022-08-01",{"date":112,"type":21},"2026-09-01",{"name":114,"class":45},"Xiaohua Wu MD"]