[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626204":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":45,"centralContacts":49,"locations":35,"responsibleParty":54,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":35,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":35,"enrollmentInfo":70,"targetDuration":35,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":86,"whyStopped":35,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":35},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Nab-Paclitaxel + Carboplatin + Aitua Combo Ab","EXPERIMENTAL","Participants receive Nab-paclitaxel (260 mg\u002Fm\\^2), Carboplatin (AUC 4-5), and Aitua Combination Antibody (5 mg\u002Fkg) intravenously on Day 1 of each 3-week cycle for 3 cycles as neoadjuvant therapy, followed by Interval Debulking Surgery (IDS).",[13,14,15,16],"Drug: Aitua Combination Antibody","Drug: Albumin-Bound Paclitaxel \u002Fnab-Paclitaxel","Drug: Carboplatin (AUC 5)","Procedure: Interval Debulking Surgery",{"label":18,"type":19,"description":20,"interventionNames":21},"Nab-Paclitaxel + Carboplatin","ACTIVE_COMPARATOR","Participants receive Nab-paclitaxel (260 mg\u002Fm\\^2) and Carboplatin (AUC 4-5) intravenously on Day 1 of each 3-week cycle for 3 cycles as neoadjuvant therapy, followed by Interval Debulking Surgery (IDS).",[14,15,16],[23,31,36,40],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Aitua Combination Antibody","Administered via intravenous infusion at a dose of 5 mg\u002Fkg on Day 1 of each 3-week cycle.",[9],[29,30],"PD-1\u002FCTLA-4 Bispecific Antibody","QL1706",{"type":24,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Albumin-Bound Paclitaxel \u002Fnab-Paclitaxel","Administered via intravenous infusion at a dose of 260 mg\u002Fm\\^2 on Day 1 of each 3-week cycle.",[18,9],null,{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Carboplatin (AUC 5)","Administered via intravenous infusion at a dose of AUC 5 on Day 1 of each 3-week cycle.",[18,9],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":35},"PROCEDURE","Interval Debulking Surgery","Performed after 3 cycles of neoadjuvant therapy. The goal is to achieve R0 resection (no macroscopic residual disease).",[18,9],[46],{"name":47,"affiliation":5,"role":48},"Ning Li, MD","PRINCIPAL_INVESTIGATOR",[50],{"name":47,"role":51,"phone":52,"phoneExt":35,"email":53},"CONTACT","8610-87787211","liningnci@126.com",{"type":48,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"NING LI-GYN","Chief Physician",[58],{"name":59,"class":60},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY","100626204","phase-2-neoadjuvant-aitua-pd-1ctla-4-bispecific-plus-nab-paclitaxel-and-carboplatin-for-advanced-high-grade-serous-ovarian-cancer-100626204",false,"NCT07432594","Neoadjuvant Aitua (PD-1\u002FCTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian Cancer","A Prospective, Randomized, Controlled Phase II Clinical Study of Albumin-Bound Paclitaxel\u002FCarboplatin Combined With Aitua Combination Antibody (PD-1\u002FCTLA-4 Bispecific Antibody) for the Neoadjuvant Treatment of Advanced High-Grade Serous Ovarian Cancer With Unsatisfactory Debulking","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed high-grade serous ovarian cancer (HGSC), fallopian tube cancer, or primary peritoneal cancer.\n* International Federation of Gynecology and Obstetrics (FIGO) stage IIIC-IV.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Assessed by a multidisciplinary team (MDT) based on imaging (± laparoscopic exploration) as initially unable to achieve satisfactory tumor debulking (R0 resection).\n* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.\n* Major organ function is basically normal.\n* Willing to provide tumor tissue, peripheral blood, and ascites samples for translational research.\n\nExclusion Criteria:\n\n* Pathological types other than high-grade serous carcinoma (HGSC).\n* Prior receipt of any form of anti-tumor therapy.\n* History of autoimmune disease or requiring immunosuppressive therapy.\n* Known allergy to study drug components.\n* Pregnant or lactating women.","FEMALE","18 Years",{"count":71,"type":72},82,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","This is a prospective, randomized, controlled Phase II clinical study designed to evaluate the efficacy and safety of adding Aitua Combination Antibody (a PD-1\u002FCTLA-4 bispecific antibody) to standard neoadjuvant chemotherapy for patients with advanced high-grade serous ovarian cancer.\n\nThe study focuses on patients who are newly diagnosed with Stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer and are assessed as unable to achieve satisfactory tumor debulking (R0 resection) initially.\n\nParticipants will be randomized in a 1:1 ratio into two groups:\n\nExperimental Group: Receives Nab-paclitaxel and Carboplatin combined with Aitua Combination Antibody.\n\nControl Group: Receives Nab-paclitaxel and Carboplatin alone.\n\nBoth groups will receive 3 cycles of neoadjuvant treatment followed by Interval Debulking Surgery (IDS). The primary goal is to compare the R0 resection rate (complete removal of macroscopic tumor) between the two groups during surgery. Secondary goals include assessing pathological complete response (pCR), objective response rate, progression-free survival, and safety. The study also aims to explore how this combination therapy affects the tumor immune microenvironment.",[78,79,80],"High-grade Serous Ovarian Cancer (HGSOC)","Fallopian Tube Cancers","Primary Peritoneal Cancer",[82,42,29,25,83,84,85],"Neoadjuvant Chemotherapy","Nab-paclitaxel","Carboplatin","Immunotherapy","NOT_YET_RECRUITING","2026-02-21",{"date":89,"type":90},"2026-02-25","ACTUAL",{"date":92,"type":72},"2026-03-01",{"date":94,"type":72},"2027-06-30",{"name":5,"class":6}]