[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624270":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":34,"centralContacts":50,"locations":56,"responsibleParty":71,"collaborators":34,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":34,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":34,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":99,"whyStopped":34,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Jiangsu Cancer Institute & Hospital","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1：QL1706+paclitaxel +carboplatin \u002Fcisplatin","EXPERIMENTAL","Cohort 1: ECOG PS 0 or 1, all-comers population, regardless of BRCA or HRD test results. Treatment: iparomlimab and tuvonralimab (5 mg\u002Fkg, Q3W, D1) + paclitaxel (175 mg\u002Fm², Q3W, D1) + carboplatin (AUC 5-6, Q3W, D1)\u002Fcisplatin (75 mg\u002Fm², Q3W, D1). Planned enrollment: 30 patients.",[13,14,15,16],"Drug: Iparomlimab and Tuvonralimab (QL1706)Injection","Drug: paclitaxel","Drug: carboplatin","Drug: Cisplatin",{"label":18,"type":10,"description":19,"interventionNames":20},"Cohort 2：QL1706+olaparib+intraperitoneal perfusion","Cohort 2: ECOG PS 2, BRCA1\u002F2 mutation or HRD positive. Treatment: iparomlimab and tuvonralimab (5 mg\u002Fkg, Q3W, D1) + olaparib (300 mg, for 2-3 cycles, bid) + intraperitoneal perfusion (cisplatin, 75 mg\u002Fm², Q3W, D1). Planned enrollment: 20 patients.",[13,21,16],"Drug: Olaparib",[23,30,35,39,43,47],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Iparomlimab and Tuvonralimab (QL1706)Injection","5 mg\u002Fkg, Q3W, D1",[9,18],[29],"QL1706",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"paclitaxel","175 mg\u002Fm², Q3W, D1",[9],null,{"type":24,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"carboplatin","AUC 5-6, Q3W, D1",[9],{"type":24,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"Cisplatin","75 mg\u002Fm², Q3W, D1",[9],{"type":24,"name":44,"description":45,"armGroupLabels":46,"otherNames":34},"Olaparib","300 mg, for 2-3 cycles, bid",[18],{"type":24,"name":40,"description":48,"armGroupLabels":49,"otherNames":34},"intraperitoneal perfusion, 75 mg\u002Fm², Q3W, D1",[18],[51],{"name":52,"role":53,"phone":54,"phoneExt":34,"email":55},"Xiao Xiang Chen","CONTACT","+86-13851647229","cxxxxcyd@gmail.com",[57],{"facility":58,"status":34,"city":59,"state":60,"zip":34,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Jiangsu Cancer Hospital","Nanjing","Jiangsu","China","CN",{"type":64,"coordinates":65},"Point",[66,67],118.77778,32.06167,{"lat":67,"lon":66},[70],{"name":52,"role":53,"phone":54,"phoneExt":34,"email":55},{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Xiaoxiang Chen","Department Director","100624270","phase-2-iparomlimab-and-tuvonralimab-ql1706-combined-with-standard-chemotherapy-or-combined-with-intraperitoneal-perfusion-chemotherapy-and-olaparib-as-neoadjuvant-therapy-for-advanced-ovarian-cancer-100624270",false,"NCT07407452","Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Chemotherapy and Olaparib as Neoadjuvant Therapy for Advanced Ovarian Cancer","A Prospective, Open-label, Multicenter Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Chemotherapy and Olaparib as Neoadjuvant Therapy for Advanced Ovarian Cancer","Inclusion Criteria:\n\n* Participants voluntarily join this study, sign the informed consent form, and strictly comply with the protocol requirements;\n* Female patients aged between 18 and 75 years;\n* Patients who have undergone open surgery, laparoscopic surgery, or core needle aspiration biopsy, and have been histopathologically confirmed as having epithelial ovarian cancer (high-grade serous adenocarcinoma, endometrioid adenocarcinoma), peritoneal cancer, or fallopian tube cancer, FIGO 2018 Stage III-IV;\n* Meet the indications for neoadjuvant chemotherapy in ovarian cancer: ① Preoperative assessment by gynecologic oncologists (with multidisciplinary consultation when necessary) indicates low likelihood of achieving R0 resection with primary debulking surgery; ② Physical condition unable to tolerate PDS, unsuitable for immediate surgery (e.g., high perioperative risk, advanced age, medical comorbidities, etc.); ③ No prior systemic anti-tumor treatment for ovarian cancer (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy, and immunotherapy); Note: Lymph node dissection or biopsy performed for clinical staging purposes after obtaining histopathology via needle biopsy, laparoscopic exploration, or other methods is permitted;\n* Accept BRCA1\u002F2 genetic mutation or HRD testing;\n* Presence of at least one measurable lesion according to RECIST 1.1 criteria;\n* Expected survival time ≥12 weeks;\n* ECOG score 0-1 (for Cohort 1), ECOG score 2 (for Cohort 2);\n* Adequate organ function, including:\n\nBone marrow function: Absolute neutrophil count ≥1,500\u002FμL; Platelets ≥100,000\u002FμL; Hemoglobin ≥10 g\u002FdL Hepatic function: Total bilirubin ≤1.5× upper limit of normal (ULN) or direct bilirubin ≤1.0× ULN; AST and ALT ≤2.5× ULN; Must be ≤5× ULN when liver metastases are present Renal function: Serum creatinine ≤1.5× ULN, or creatinine clearance ≥60 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n\n* Participants of childbearing potential must use appropriate contraceptive methods during the study period and for 120 days after study completion, have a negative serum pregnancy test within 7 days before study enrollment, and must be non-lactating participants.\n\nExclusion Criteria:\n\n* Non-epithelial origin ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (e.g., germ cell tumors); ovarian tumors of low malignant potential (e.g., borderline tumors);\n* Concurrent use of other cancer neoadjuvant therapies during this study, including but not limited to chemotherapy, radiotherapy, immunotherapy, microbial therapy, traditional Chinese medicine, and other experimental therapies;\n* Hypersensitivity to the active or inactive ingredients of the investigational drug or drugs with similar structure to the investigational drug;\n* Inability to swallow oral medications and any gastrointestinal disorders that may interfere with the absorption and metabolism of study drugs (for Cohort 2);\n* Prior treatment with known or suspected poly (ADP-ribose) polymerase (PARP) inhibitors (for Cohort 2);\n* Presence of symptomatic or uncontrolled brain metastases requiring concurrent treatment;\n* Active or potentially recurrent autoimmune disease; exceptions include: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism caused by autoimmune thyroiditis requiring only stable dose hormone replacement therapy; Type 1 diabetes requiring only stable dose insulin replacement therapy;\n* Major surgery within 3 weeks before study initiation, or incomplete recovery from surgery;\n* History of organ transplantation, autologous\u002Fallogeneic stem cell transplantation;\n* Known or self-reported human immunodeficiency virus (HIV) infection;\n* HBV-DNA positive, HCV-DNA positive (copy number \\>10³);\n* Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40, etc.), immune cell therapy, or any other treatments targeting tumor immune mechanisms;\n* Live vaccine administered within 4 weeks before first dose, or planned live vaccine administration during the study period;\n* History of other malignancies within the past 3 years, except for cutaneous squamous cell carcinoma, basal cell carcinoma, ductal carcinoma in situ of the breast, or cervical carcinoma in situ;\n* Prior or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);\n* Patients who received platelet or red blood cell transfusions within 4 weeks before initiation of study drug treatment;\n* Pregnant, lactating, or patients planning to become pregnant during study treatment;\n* Patients deemed unsuitable for participation in this study by the investigator.","FEMALE","18 Years","75 Years",{"count":86,"type":87},50,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","This study is a prospective, open-label, multicenter Phase II clinical trial, planning to enroll 50 patients with advanced ovarian cancer. Enrolled participants will be assigned to 2 cohorts based on ECOG performance status and genetic mutation status:\n\nCohort 1: ECOG PS 0 or 1, all-comers population, regardless of BRCA or HRD test results. Treatment: iparomlimab and tuvonralimab (5 mg\u002Fkg, Q3W, D1) + paclitaxel (175 mg\u002Fm², Q3W, D1) + carboplatin (AUC 5-6, Q3W, D1)\u002Fcisplatin (75 mg\u002Fm², Q3W, D1). Planned enrollment: 30 patients.\n\nCohort 2: ECOG PS 2, BRCA1\u002F2 mutation or HRD positive. Treatment: iparomlimab and tuvonralimab (5 mg\u002Fkg, Q3W, D1) + olaparib (300 mg, for 2-3 cycles, bid) + intraperitoneal perfusion (cisplatin, 75 mg\u002Fm², Q3W, D1). Planned enrollment: 20 patients.\n\nNeoadjuvant therapy will be administered for 3 cycles, followed by patient status assessment. Patients with CR\u002FPR\u002FSD will be allowed to undergo surgery, while PD patients will have subsequent treatment strategies determined by the investigator.",[93],"Ovarian Cancers",[95,96,97,29,98],"ovarian cancer","ICIs","Neoadjuvant therapy","olaparib","NOT_YET_RECRUITING","2026-02-10",{"date":102,"type":103},"2026-02-12","ACTUAL",{"date":105,"type":87},"2026-02-01",{"date":107,"type":87},"2028-12-31",{"name":5,"class":6},1]