[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562353":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":35,"locations":44,"responsibleParty":75,"collaborators":77,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":23,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":23,"studyType":96,"phases":97,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":110,"whyStopped":23,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Shanghai Gynecologic Oncology Group","OTHER_GOV",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"criteria-fulfilled arm","EXPERIMENTAL","Patients who meet the inclusion and exclusion criteria will receive secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy with Iparomlimab\u002Ftuvonralimab maintenance therapy.",[13,14],"Procedure: surgery\u002Fchemotherapy","Drug: Iparomlimab\u002FTuvonralimab",{"label":16,"type":10,"description":17,"interventionNames":18},"compassionate use arm","Patients who are enrolled under expanded eligibility criteria will receive secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy with Iparomlimab\u002Ftuvonralimab maintenance therapy.",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"real world arm","NO_INTERVENTION","Patients who meet the inclusion and exclusion criteria but refuse to participate in the CF and CU arms will receive the physician's therapy of choice.",null,[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"PROCEDURE","surgery\u002Fchemotherapy","secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy",[16,9],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":23},"DRUG","Iparomlimab\u002FTuvonralimab","Iparomlimab\u002Ftuvonralimab will be administered at a dose of 5 mg per kilogram IV every 21 days. Treatment will continue until disease progression confirmed by RECIST criteria v1.1, intolerable toxicity or withdrawal of consent.",[16,9],[36,41],{"name":37,"role":38,"phone":39,"phoneExt":23,"email":40},"Tingyan Shi, MD, PHD","CONTACT","86-21-64041990","shi.tingyan@zs-hospital.sh.cn",{"name":42,"role":38,"phone":39,"phoneExt":23,"email":43},"Yulian Chen, MD","emma_serendipity@163.com",[45,61],{"facility":46,"status":23,"city":47,"state":23,"zip":23,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Zhongshan Hospital Fudan University","Shanghai","China","CN",{"type":51,"coordinates":52},"Point",[53,54],121.45806,31.22222,{"lat":54,"lon":53},[57,58],{"name":37,"role":38,"phone":23,"phoneExt":23,"email":40},{"name":59,"role":60,"phone":23,"phoneExt":23,"email":23},"Rongyu Zang, MD, PHD","PRINCIPAL_INVESTIGATOR",{"facility":62,"status":23,"city":63,"state":23,"zip":23,"country":48,"countryCode":49,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology","Wuhan",{"type":51,"coordinates":65},[66,67],114.26667,30.58333,{"lat":67,"lon":66},[70,73],{"name":71,"role":38,"phone":23,"phoneExt":23,"email":72},"Qinglei Gao, MD, PHD","gingleigao@hotmiail.com",{"name":74,"role":60,"phone":23,"phoneExt":23,"email":23},"Qinglei Gao, MD,PHD",{"type":76,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[78,81],{"name":79,"class":80},"Shanghai Zhongshan Hospital","OTHER",{"name":82,"class":80},"Tongji Hospital","100562353","phase-1-surgery-for-relapsed-ovarian-cancer-in-precision-100562353",false,"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.","FEMALE","18 Years","80 Years",{"count":94,"type":95},33,"ESTIMATED","INTERVENTIONAL",[98,99],"PHASE1","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).",[102,103,104],"Epithelial Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Carcinoma",[106,107,108,109],"Ovarian cancer","Immune checkpoint inhibitor","Secondary cytoreduction","Biomarker-driven","NOT_YET_RECRUITING","2025-06-24",{"date":113,"type":114},"2025-06-27","ACTUAL",{"date":116,"type":95},"2025-07",{"date":118,"type":95},"2030-06",{"name":5,"class":6},2]