[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Gynecologic Oncology Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":221},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,48,77,103,125,146,172,199],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644807","phase-1-immu-132-in-trop-2-overexpressed-advanced-and-relapsed-ovarian-cancer-100644807",false,"NCT07674615","IMMU-132 in TROP-2 Overexpressed Advanced and Relapsed Ovarian Cancer","IMMU-132 in TROP-2 Overexpressed Advanced and Relapsed Ovarian Cancer: A Phases Ib, Single Arm Study","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 80 years;\n* Histologically confirmed advanced or recurrent high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer;\n* Recurrent patients meeting one of the following two conditions:\n\nDisease recurrence or progression after at least one prior platinum-based chemotherapy regimen, with disease progression occurring less than 6 months from the last dose of platinum-based chemotherapy;\n\n* Disease recurrence or progression after at least three prior platinum-based chemotherapy regimens, with disease progression occurring ≥ 6 months from the last dose of platinum-based chemotherapy, and who are unable to receive standard platinum-based chemotherapy;\n* Patients with advanced epithelial ovarian cancer presenting with hematogenous metastasis, who are unable to receive standard treatment, with an estimated life expectancy of more than 3 months but approximately not exceeding 12 months with current therapy;\n* Have measurable disease per RECIST 1.1 criteria (Appendix A) or diagnosis of recurrence\u002Fdisease progression per GCIG criteria;\n* Known BRCA (Breast Cancer Gene) and HRD (Homologous Recombination Deficiency) status;\n* Have available paraffin-embedded or fresh tumor tissue for TROP-2 testing;\n* Tumor tissue TROP-2 H-score \\> 200;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;\n* Adequate bone marrow hematopoietic function and organ function, allowing the patient to receive treatment;\n* Patients must have had at least a 2-week interval from prior therapy (chemotherapy, investigational agents including small molecule inhibitors, endocrine therapy, immunotherapy, and\u002For radiotherapy) or major surgery;\n* Patients must have had at least a 2-week interval from high-dose systemic corticosteroids (however, low-dose corticosteroids \\\u003C 20 mg prednisone or its equivalent are permitted);\n* Patients must have recovered from acute toxicity due to prior therapy to Grade 1 or below;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients who have previously received topoisomerase I inhibitor therapy;\n* Patients with known hypersensitivity to the study drug, its metabolites, or formulation excipients;\n* Patients requiring ongoing treatment or prior use of any prohibited medications (e.g., UGT1A1 inhibitors);\n* Patients with Gilbert's syndrome;\n* Patients with other uncontrolled malignancies concurrently or within 5 years, whose treatment would interfere with the current therapy for recurrent ovarian cancer or affect the prognosis of this treatment. Carcinoma in situ and breast cancer (without active disease or signs of recurrence) are excluded;\n* Patients with a history of clinically significant hemorrhage, bowel obstruction, or gastrointestinal perforation within 6 months prior to the start of study treatment, with an estimated life expectancy of less than 3 months;\n* Patients with a history of significant cardiac disease within 6 months, such as uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure (NYHA Class III-IV), or clinically significant arrhythmias requiring antiarrhythmic therapy (except stable atrial fibrillation);\n* Patients with known clinically significant active chronic obstructive pulmonary disease (COPD) or other moderate-to-severe chronic respiratory disease within 6 months;\n* Patients with known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose, have all neurological symptoms returned to baseline, have no evidence of new or enlarging brain metastases, and are on a daily dose of ≤ 20 mg prednisone or its equivalent. All patients with carcinomatous meningitis are excluded regardless of clinical stability;\n* Patients with uncontrolled seizure history or active neurologic disorders; Patients with known HIV-1 or HIV-2 (or HIV-1\u002F2 antibody positive) with detectable viral load, or those taking medications that may interfere with SN-38 metabolism;\n* Patients with active HBV or HCV. For patients with a history of HBV or HCV, those with detectable viral load will be excluded;\n* Patients with known bleeding diathesis or active bleeding disorders;\n* Patients with active ≥ Grade 2 anorexia, nausea, or vomiting, and\u002For signs of bowel obstruction;\n* Patients with other concurrent medical or psychiatric conditions that, in the investigator's opinion, may confound study interpretation or prevent completion of study procedures and follow-up examinations;\n* Patients with any unstable medical problems (including the cardiac issues mentioned above, active treatment for symptomatic pulmonary embolism, stroke, renal or hepatic insufficiency, active infection\u002Fsepsis requiring intravenous antibiotics);\n* Any medical condition that, in the investigator's opinion, poses an undue risk to the patient's participation in the study.","FEMALE","18 Years","80 Years",{"count":20,"type":21},19,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","To observe the efficacy and safety of IMMU-132 in patients with advanced or recurrent ovarian cancer with high TROP-2 expression in tumor tissue, who have failed standard therapy or are unable to receive standard treatment.",[27,28,29,30],"Epithelial Ovarian Cancer","Fallopian Tube Cancers","Primary","Primary Peritoneal Carcinoma",[32,33,34],"Ovarian cancer","TROP2","Antibody-drug conjugates","NOT_YET_RECRUITING","2026-06-28",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":21},"2026-07-01",{"date":43,"type":21},"2027-06-30",{"name":45,"class":46},"Shanghai Gynecologic Oncology Group","OTHER_GOV",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":47},"100457445","survival-effect-of-hepato-celiac-lymphadenectomy-in-primary-or-relapsed-ovarian-cancer-100457445","NCT05236686","Survival Effect of Hepato-celiac Lymphadenectomy In Primary or Relapsed Ovarian Cancer","A Prospective, Multi-center, Single-Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Hepato-celiac Lymphadenectomy in the Treatment of Advanced and Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Age ≥18 years to ≤ 75 years.\n* Pathologic confirmed stage III or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (EOC, PPC, FTC) or platinum sensitive, relapsed EOC, PPC or FTC (no more than 4 lines of therapy)\n* Hepato-celiac lymph nodes metastases diagnosed by imaging before surgery and enlarged palpable lymph nodes by surgical findings\n* Assessed by the experienced surgeons, complete resection is feasible according to preoperative evaluation\n* 1 to 3 episodes of neoadjuvant chemotherapy is allowed in primary settings\n* Platinum sensitive relapse is defined as those with platinum-free interval of 6 months or more.\n* ASA score of 1 to 2\n* ECOG performance status of 0 to 2\n* Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:\n* White blood cells \\>3,000\u002FµL, absolute neutrophil count ≥1,500\u002FµL, platelets ≥100,000\u002FµL, hemoglobin ≥9 g\u002FdL,\n* Serum creatinine \\\u003C1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL\u002Fmin according to Cockcroft-Gault formula or to local lab measurement\n* Serum bilirubin \\\u003C1.25 x UNL, AST(SGOT) and ALT(SGPT) \\\u003C2.5 x UNL\n* Comply with the study protocol and follow-up.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Patients with non-epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma.\n* Low-grade carcinoma.\n* Mucinous ovarian cancer.\n* Infeasible complete resection according to preoperative evaluation\n* Unresectable pulmonary and hepatic parenchymal metastases, multiple thoracic lymph nodes metastases, brain or bone metastases according to preoperative evaluation.\n* Carcinomatosis on small bowel mesentery or intestinal wall by surgical findings and infeasible optimal surgery by bowel resection or peritonectomy.\n* Progression after neoadjuvant chemotherapy in primary settings.\n* Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast cancer (without any signs of relapse or activity).\n* Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.\n* Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.","75 Years",{"count":57,"type":21},94,[59],"NA","The purpose of this study is to evaluate the safety and the effectiveness of hepato-celiac lymphadenectomy in the treatment of primarily diagnosed advanced epithelial ovarian cancer and platinum-sensitive recurrent ovarian cancer.",[27,62,30],"Fallopian Tube Cancer",[64,65,66,67],"Ovarian Cancer","Surgery","Lymph Node Metastasis","Hepato-celiac Lymphadenectomy","RECRUITING","2025-11-16",{"date":71,"type":39},"2025-11-19",{"date":73,"type":39},"2022-02-15",{"date":75,"type":21},"2025-12",{"name":45,"class":46},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100562353","phase-1-surgery-for-relapsed-ovarian-cancer-in-precision-100562353","NCT06602063","Surgery for Relapsed Ovarian Cancer in Precision","Surgery With ICBs in BRCAwt, CD8+ TILs, 1st Relapsed Ovarian Cancer: A Pilot Study","Inclusion Criteria:\n\n* Arm 1 (criteria-fulfilled, CF)\n\n  1. Age at recurrence ≥ 18 years, \\\u003C80 years.\n  2. Patients with platinum-sensitive, first relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC, PPC, FTC), which is defined as those with treatment -free interval of 6 months or more.\n  3. If the patient had previous PARPi maintenance therapy, disease progression should occurring at lease 3 months after the prior PARPi withdrawal.\n  4. BRCA1\u002F2 wild type (both germline and somatic)\n  5. Homologous Recombination Deficiency (HRD) is available\n  6. Patients must provide archived or fresh tumor tissue samples for biomarker detection.\n  7. PD-L1 positive (if either at least 1% of assessed tumour cells expressed membranous PD-L1, at least 5% of immune cells within the tumour area expressed PD-L1, or both) and number of intraepithelial CD8+ tumor-infiltrating lymphocytes (TILs) per high-powered field ≥ 6.\n  8. Assessed by the experienced surgeons, complete resection of all recurrent disease is possible (predicted by iMODEL score or by PET\u002FCT).\n  9. ECOG performance status of 0 to 2\n  10. Adequate bone marrow, liver, and renal function to receive combined immunotherapy\n  11. Written informed consent\n* Arm 2 (compassionate use, CU), Similar to cohort 1, except for:\n\n  1. If the patient had previous PARPi maintenance therapy, disease progression should occurring within 3 months after the prior PARPi withdrawal or during the PARPi maintenance therapy.\n  2. PD-L1 positive or number of intraepithelial CD8+ TILs per high-powered field ≥ 6.\n* Arm 3 (real word) Patients who meet the inclusion criteria but refuse to participate in the phase II CF and CU cohorts.\n\nExclusion Criteria:\n\n1. Patients with borderline, low-grade tumors, clear cell carcinoma, as well as non-epithelial tumors.\n2. Patients with platinum-resistant or refractory diseases.\n3. Lack of tumor samples (archived and\u002For recently obtained) for biomarker detection.\n4. Previous administration of immunotherapy\n5. Patients have been vaccinated with the live vaccine or received anti-tumor treatment within 4 weeks before the first administration.\n6. Synchronous or metachronous (within 5 years) malignancy, symptomatic or uncontrolled visceral metastases that require simultaneous treatment, other than carcinoma in situ or breast cancer (without any signs of relapse or activity).\n7. Patients with parenchymal metastases and life-threatening complications in short term.\n8. Any other concurrent medical conditions contraindicating surgery, chemotherapy, or immunotherapy that could compromise the adherence to the protocol.\n9. Patients are known to be allergic to the active ingredients or excipients of Sintilimab.\n10. HRD status is not available.\n11. Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents or bevacizumab.\n12. Patients for interval-debulking, or for second-look surgery, or palliative surgery planned.\n13. Impossible to assess the resectability of recurrent disease or evaluate the score. Radiological signs suggesting complete resection is impossible.",{"count":85,"type":21},33,[24,87],"PHASE2","This multicenter, biomarker-driven, patient-centric study aimed to evaluate the efficacy of secondary cytoreduction followed by platinum-based chemotherapy in combination with anti-PD1\u002FCTLA-4 bispecifics therapy in patients with platinum-sensitive relapsed ovarian cancer (PSROC).",[27,62,30],[32,91,92,93],"Immune checkpoint inhibitor","Secondary cytoreduction","Biomarker-driven","2025-06-24",{"date":96,"type":39},"2025-06-27",{"date":98,"type":21},"2025-07",{"date":100,"type":21},"2030-06",{"name":45,"class":46},2,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":47},"100581139","phase-1-sct-001-car-t-cells-therapy-for-relapsed-and-refractory-ovarian-cancer-100581139","NCT06846424","SCT-001 CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer","A Clinical Study to Evaluate the Safety and Tolerability of SCT-001 CAR-T Cells in Patients with Recurrent and Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Peritoneal Cancer.","Inclusion Criteria:\n\n* Subjects must meet all of the following criteria for admission to this study:\n\nAge≥ 18 years old;\n\n* ECOG performance status score: 0\\~2 points or KPS score≥70 points;\n* Relapsed or refractory epithelial ovarian, fallopian tube and peritoneal cancer confirmed by histology or cytology and have failed, are intolerant or have no standard treatment after standard therapy;\n* Tumor tissue specimens or tumor samples can be obtained by tumor biopsy and other methods;\n* Immunohistochemistry (IHC) staining confirmed that the tumor cells had positive TAG-72 expression (positive definition: \\>). IHC staining intensity of 1% tumor cells ≥2+);\n* Estimated survival time of more than 3 months;\n* At least one evaluable tumor lesion according to RECIST 1.1;\n* Prior to treatment, major organ function met the following criteria (no blood transfusion, long-acting EPO, long-acting G-CSF therapy within 14 days prior to study drug administration, in the case of short-acting EPO, short-acting G-CSF, this criterion can be shortened to 7 days):\n* complete blood count: Absolute neutrophil count (ANC) ≥1.5×109\u002FL,, Absolute lymphocyte count (ALC) ≥ 0.5×109\u002FL; hemoglobin (HGB) ≥ 80 g\u002FL; Platelets (PLT) ≥ 75×109\u002FL;\n* Renal: serum creatinine ≤1.5× upper limit of normal range (ULN);\n* Liver: total bilirubin ≤ 1.5× ULN (including patients with liver metastases or liver cancer), AST and ALT ≤ 2.5× ULN (liver metastases ≤5×ULN);\n* Coagulation: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5× ULN, partially activated thromboplastin time (APTT) ≤ 1.5× ULN;\n* Must be using adequate contraception during the study and for 6 months after the end of the study, have a negative serum pregnancy test within 7 days prior to proposed enrollment in the study, and must be a non-lactating subject.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria will not be admitted to this study:\n* Those who are allergic to any component of SCT-001 CAR-T cell injection;\n* Received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc., or participated in other clinical trials and received 5 half-lives of therapeutic drugs within 4 weeks prior to the first use of the study drug (4 weeks or 5 half-lives, whichever is shorter);\n* Received treatment with traditional Chinese medicine or modern Chinese medicine preparations with anti-tumor indications in the label within 14 days before the first dose;\n* The adverse reactions of previous anti-tumor therapy have not recovered to NCI CTCAE v5.0 grade evaluation ≤ grade 1 (except for toxicity that the investigator judges has no safety risk such as alopecia);\n* Surgical procedure within 4 weeks prior to treatment or has not fully recovered from any previous invasive procedure;\n* Central nervous system metastases or meningeal metastases with clinical symptoms, or other evidence that the subject's central nervous system metastases or meningeal metastases have not been controlled, and are judged by the investigator to be unsuitable for enrollment;\n* Those with active infection (NCI CTCAE v5.0≥ grade 2) or any other person with suspected risk of infection as assessed by the investigator;\n* Has a history of autoimmune disease, immunodeficiency, including a positive HIV test, or has other acquired, congenital immunodeficiency diseases, or has a history of organ transplantation;\n* Subjects with active hepatitis B or active hepatitis C;\n* Those who have used immune cell therapy in the past;\n* History of severe cardiovascular disease, such as severe cardiac rhythm or conduction abnormalities (ventricular arrhythmia requiring clinical intervention, II.\\~III. degree atrioventricular block, etc.), myocardial infarction, history of coronary artery bypass surgery, heart failure, New York College of Cardiology (NYHA) grade II or above, left ventricular ejection fraction (LVEF) ≤50% and thrombosis found, male QTcF \\>450msec or female QTcF \\>470msec, etc.;\n* Subjects with a history of severe cerebrovascular diseases such as stroke;\n* Need to combine with other anti-tumor therapies (including various radiotherapy, chemotherapy, immunotherapy, targeted therapy, traditional Chinese medicine therapy, etc.);\n* Previous clear history of neurological or psychiatric disorders, including epilepsy or dementia;\n* In the opinion of the investigator, the subject has other reasons that make it unsuitable to participate in this clinical study.",{"count":111,"type":21},24,[24],"This study is an open-label, dose-escalation, investigator-initiated phase I interventional clinical study. To evaluate the safety, tolerability and preliminary efficacy of SCT-001 CAR-T cell injection in subjects with relapsed and refractory epithelial ovarian, fallopian tube and peritoneal cancer, and to explore the pharmacokinetic characteristics, biomarker changes and immunogenicity of SCT-001 CAR-T cell injection in subjects with relapsed and refractory epithelial ovarian, fallopian tube and peritoneal cancer.\n\nIn this study, two trial cohorts were set up, cohort 1 was the intraperitoneal route of administration, and the subjects enrolled in cohort 1 needed to meet the conditions for intraperitoneal administration ((1) the subject had a large amount of ascites, (2) the subject was suitable for peritoneal catheterization, (3) the subject had no severe abdominal adhesions, and (4) the subject agreed to undergo intraperitoneal surgical catheterization for intraperitoneal administration); Cohort 2 is the intravenous route.",[64,115,116],"Fallopian Tube Carcinoma","Peritoneal Carcinoma","2025-02-20",{"date":119,"type":39},"2025-02-26",{"date":121,"type":21},"2025-06-01",{"date":123,"type":21},"2030-06-01",{"name":45,"class":46},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":4},"100580525","parpi-and-ovarian-cancer-survival-100580525","NCT06838429","PARPi and Ovarian Cancer Survival","Effect of PARP Inhibitors Maintenance Therapy on the Survival Rate of Advanced or Relapsed Epitherlial Ovarian Cancer: an Observational Cohort Study","Inclusion Criteria:\n\nGroup 1:\n\n* Patients newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer between December 2013 and December 2024.\n* Complete data on first-line treatment and maintenance therapy.\n* Availability of follow-up data.\n\nGroup 2:\n\n* Patients with platinum-sensitive first recurrence of any stage of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, diagnosed between December 2013 and December 2024.\n* Disease progression occurring at least 6 months after the completion of the last platinum-based chemotherapy regimen.\n* Complete data on second-line treatment and maintenance therapy.\n* Availability of follow-up data.\n\nExclusion Criteria:\n\nGroup 1:\n\n* Non-epithelial tumors, borderline tumors, clear cell carcinoma, mucinous carcinoma.\n* Missing first-line or follow-up data.\n\nGroup 2:\n\n* Non-epithelial tumors, borderline tumors, clear cell carcinoma, mucinous carcinoma.\n* Patients with second relapse.\n* Platinum-resistant patients, such as those who had disease progression during chemotherapy or within 6 months after platinum-based chemotherapy.\n* Missing second-line or follow-up data.",{"count":133,"type":21},6000,"OBSERVATIONAL","With the widespread use of PARP inhibitors (PARPi) as maintenance therapy in ovarian cancer, there is still a lack of real-world data from large samples regarding their impact on survival outcomes in advanced and recurrent ovarian cancer. This study aims to conduct a pragmatic cohort study to evaluate the impact of first-line and second-line maintenance treatment with PARPi on survival rates in patients with advanced and recurrent ovarian cancer. The genetic status, different PARPi drugs, and the use of anti-angiogenic inhibitor maintenance therapy or not is used as confounding factors.",[137,138],"Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum","PARP Inhibitor","2025-02-17",{"date":117,"type":39},{"date":142,"type":21},"2025-03",{"date":144,"type":21},"2026-03",{"name":45,"class":46},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":158,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100454647","phase-2-surgery-combined-with-maintenance-targeted-therapy-in-the-treatment-of-advanced-ovarian-cancer-100454647","NCT05200260","Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer","A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer","Inclusion Criteria:\n\n* Females aged ≥ 18 years.\n* Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma\n* Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET\u002FCT examination\n* Complete cytoreduction can be achieved based on CT or PET\u002FCT examination\n* Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing\n* Performance status (ECOG 0-2)\n* Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:\n\n  1. white blood cells \\>3,000\u002FµL, absolute neutrophil count ≥1,500\u002FµL, platelets ≥100,000\u002FµL, hemoglobin ≥9 g\u002FdL,\n  2. serum creatinine \\\u003C1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL\u002Fmin according to Cockroft-Gault formula or to local lab measurement,\n  3. serum bilirubin \\\u003C1.25 x UNL, AST(SGOT) and ALT(SGPT) \\\u003C2.5 x UNL.\n* Comply with the study protocol and follow-up.\n* Patients who have given their written informed consent.\n\nExclusion Criteria:\n\n* Non-epithelial ovarian malignancies and borderline tumors\n* Low grade ovarian cancer\n* Mucinous ovarian cancer\n* Complete cytoreduction cannot be achieved according to preoperative evaluation, including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases\n* Patient has a known hypersensitivity to the components of olaparib\u002Fbevacizumab or its excipients\n* Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, thyroid carcinoma, or breast carcinoma (without any signs of relapse or activity, early-stage).\n* Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise adherence to the protocol.\n* Other conditions, such as religious, psychological, and other factors, that could interfere with the provision of informed consent, compliance to study procedures, or follow-up.",{"count":154,"type":21},220,[87],"Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer",[64,62,30],[64,159,160,161,162],"Primary Debulking Surgery","Neoadjuvant chemotherapy","Poly-adenosine Ribose Phosphate Inhbitors (PARPi)","Bevacizumab","2025-02-06",{"date":165,"type":39},"2025-02-10",{"date":167,"type":39},"2022-07-13",{"date":169,"type":21},"2027-06",{"name":45,"class":46},9,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},"100361213","phase-2-surgery-and-niraparib-in-secondary-recurrent-ovarian-cancer-soc-3-trial-100361213","NCT03983226","Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)","A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Age ≥18 years to ≤ 75 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Patients with platinum-sensitive, secondary relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer.\n* Front-line or second-line treatment may have included maintenance therapy (i.e. bevacizumab, PARP inhibitor)\n\n  * Cohort 1 and Cohort 3: No prior use of PARP inhibitor.\n  * Cohort 2: Prior use of PARP inhibitor.\n  * Cohort 3: No prior use of PARP inhibitor.\n* Secondary cytoreductive surgery (SCR) when first recurrence\n\n  * Cohort 1 and Cohort 2: Never received SCR\n  * Cohort 2: Never received SCR\n  * Cohort 3: Received SCR\n* Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. Single or localized lesions identified by CT, or MRI, or positron emission tomography\u002Fcomputed tomography (PET\u002FCT). PI and Co-PI reach consensus if extensive lesions or carcinomatosis.\n* It can be included if single lesion outside the peritoneal cavity can be resected.\n* No more than 3 disease lesions by central-reviewed PET\u002FCT imaging if the participated center has never participated in any surgical trials on ovarian cancer before.\n* Patients who have given their signed and written informed consent and their consent.\n\nExclusion Criteria:\n\n* Patients with borderline tumors as well as non-epithelial tumors.\n* Patients for interval-debulking, or for second- or third-look surgery, or palliative surgery planned.\n* Impossible to assess the resectability. Radiological signs suggesting complete resection is impossible.\n* Patients who have received more than two previous regimen of chemotherapy (maintenance is not considered a third regimen).\n* Third relapse or more.\n* Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.\n* Progression during chemotherapy or recurrence within 6 months after second-line platinum-based therapy\n* Any contradiction not allowing surgery and\u002For chemotherapy and\u002For or Niraparib\n* Accompanied by hypoxia serious chronic obstructive pulmonary disease\n* Uncontrolled hypertension, cerebrovascular accident\u002F Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine.\n* Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency\n* Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment\u002Fprevent ulcers therapy.\n* Uncontrolled diabetes\n* Uncontrolled epilepsy need long-term antiepileptic treatment.\n* Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents.\n* ≥3 grade anemia, neutropenia or thrombocytopenia due to chemotherapy, and lasted for more than 4 weeks\n* Patients with a known hypersensitivity to Niraparib or any of the excipients of the product.",{"count":180,"type":21},167,[87],"This is a Phase II, open-label, multicenter, randomized umbrella study to evaluate the efficacy of cytoreductive surgery and Niraparib maintenance in participants with platinum-sensitive secondary recurrent ovarian cancer. Cohort 1 will focus on participants without prior use of PARP inhibitor, and without prior secondary cytoreduction (SCR) when first recurrence. Cohort 2 will focus on participants with prior use of PARP inhibitor, but without prior SCR when first recurrence. Cohort 3 will focus on participants with SCR when first recurrence, but without prior use of PARP inhibitor.",[184,62,30],"Ovarian Cancer Recurrent",[186,187,188,189],"reurrent Ovarian Cancer","Secondary Cytoreductive Surgery","Chemotherapy","Niraparib maintenance","2022-03-04",{"date":192,"type":39},"2022-03-18",{"date":194,"type":39},"2019-10-18",{"date":196,"type":21},"2026-12",{"name":45,"class":46},5,{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},"100402080","phase-3-stratified-evaluation-of-pds-and-nact-ids-in-ovarian-cancer-focus-100402080","NCT04515602","Stratified Evaluation of PDS and NACT-IDS in Ovarian Cancer (FOCUS)","Stratified Evaluation and Prediction of Survival Benefit for PDS or NACT-IDS in Advanced Ovarian Cancer, A Randomized, Phase 3 Trial After the SUNNY Study","For Part 1:\n\nInclusion Criteria:\n\n1. Females aged ≥ 18 years.\n2. Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (diagnosis by biopsy or core needle biopsy\\*, laparoscopic biopsy is not recommended). \\* If core needle biopsy could not be performed, patients should satisfy the following conditions:\n\n   1. the patient has a pelvic mass, and\n   2. omental cake or other metastasis larger than 2 cm in the upper abdomen, or pathologic confirmed extra-abdominal metastasis (FIGO IV), and\n   3. preoperative CA125\u002FCEA ratio \\> 25. If CA125\u002FCEA ratio ≤ 25, imaging or endoscopy is obligatory to exclude a primary gastric, colon, or breast carcinoma.\n3. cPCI score ≤ 8.\n4. Performance status (ECOG 0-2).\n5. Good ASA score (1\u002F2).\n6. Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:\n\n   1. white blood cells \\>3,000\u002FµL, absolute neutrophil count ≥1,500\u002FµL, platelets ≥100,000\u002FµL, hemoglobin ≥9 g\u002FdL,\n   2. serum creatinine \\\u003C1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL\u002Fmin according to Cockroft-Gault formula or to local lab measurement,\n   3. serum bilirubin \\\u003C1.25 x UNL, AST(SGOT) and ALT(SGPT) \\\u003C2.5 x UNL.\n7. Comply with the study protocol and follow-up.\n8. Patients who have given their written informed consent.\n\nExclusion Criteria:\n\n1. Non-epithelial ovarian malignancies and borderline tumors.\n2. Low grade ovarian cancer.\n3. Mucinous ovarian cancer.\n4. cPCI score \\> 8.\n5. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity).\n6. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.\n7. Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.\n\nFor Part 2:\n\nInclusion Criteria:\n\n1. Females aged ≥ 18 years, and \\\u003C 70 years.\n2. Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma.\n3. cPCI score ≥ 10.\n4. For FIGO IVB patients, abdominal lesions should be confined to one lobe of liver parenchyma metastasis or splenic metastasis. All extra-abdominal metastases should be resectable, such as inguinal lymph nodes, solitary supraclavicular, retrocrural or paracardial nodes.\n5. Good performance status (ECOG 0-1).\n6. Good ASA score (1\u002F2).\n7. Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery.\n8. Comply with the study protocol and follow-up.\n9. Patients who have given their written informed consent.\n\nExclusion Criteria:\n\n1. Non-epithelial ovarian malignancies and borderline tumors.\n2. Low grade ovarian cancer.\n3. Mucinous ovarian cancer.\n4. Clear cell carcinoma.\n5. cPCI score \\\u003C 8.\n6. Lung metastasis, diffused pleural metastasis, bone metastasis, metastasis of mediastinal lymph node, internal mammary node, or multiple extra-peritoneal lymph nodes.\n7. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity).\n8. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.\n9. Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.",{"count":207,"type":21},410,[209],"PHASE3","The purpose of this study is to answer the fundamental question 'The Optimal Timing of Surgery' in advanced ovarian cancer patients with different tumor burden, and to perform translational study.",[27,62,30],"2020-08-25",{"date":214,"type":39},"2020-08-27",{"date":216,"type":21},"2021-01",{"date":218,"type":21},"2028-01",{"name":45,"class":46},4,""]