[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642400":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":36,"locations":47,"responsibleParty":68,"collaborators":23,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":23,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":50,"whyStopped":23,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"QL1706 + TP\u002FTC Neoadjuvant Chemoimmunotherapy","EXPERIMENTAL","Participants receive up to 4 cycles of neoadjuvant therapy (once every 3 weeks) with iparomlimab and tuvonralimab (QL1706 250 mg, IV) plus paclitaxel (150-175 mg\u002Fm², IV) and either cisplatin (70-75 mg\u002Fm², IV, split over 2 days) or carboplatin (AUC=5, IV). Treatment response is assessed after 2 cycles. For patients achieving tumor shrinkage, neoadjuvant therapy continues for 2 additional cycles followed by imaging. Patients achieving complete response (CR) undergo cervical conization plus sentinel lymph node biopsy (SLNB) or pelvic lymph node dissection (PLND). Those achieving partial response (PR) or non-optimal pathological response after surgery undergo radical hysterectomy\u002Ftrachelectomy plus SLNB\u002FPLND. Participants who achieve optimal pathological response (pCR or residual tumor depth ≤3 mm) after surgery receive QL1706 maintenance therapy for up to 8 cycles (once every 3 weeks). Patients who cannot tolerate surgery or have contraindications undergo radical radiotherapy.",[13,14,15,16],"Drug: Iparomlimab and Tuvonralimab (QL1706)","Drug: Paclitaxel","Drug: Cisplatin","Drug: Carboplatin",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Iparomlimab and Tuvonralimab (QL1706)","250 mg administered intravenously over at least 30 minutes on Day 1 of each 21-day cycle for up to 4 cycles as neoadjuvant therapy, and up to 8 cycles as maintenance therapy (for patients achieving optimal pathological response).",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Paclitaxel","150-175 mg\u002Fm² administered intravenously over at least 3 hours on Day 1 of each 21-day cycle for up to 4 cycles, with standard premedication to prevent hypersensitivity.",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Cisplatin","70-75 mg\u002Fm² administered intravenously over at least 1 hour, split over two consecutive days (Day 1 and Day 2) of each 21-day cycle for up to 4 cycles.\n\nCisplatin or Carboplatin according to investigator's choice",[9],{"type":19,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"Carboplatin","AUC=5 administered intravenously over at least 1 hour on Day 1 of each 21-day cycle for up to 4 cycles.\n\nCisplatin or Carboplatin according to investigator's choice",[9],[37,42],{"name":38,"role":39,"phone":40,"phoneExt":23,"email":41},"Jihong Liu, Ph.D.","CONTACT","+86 20 87341779","liujih@sysucc.org.cn",{"name":43,"role":39,"phone":44,"phoneExt":45,"email":46},"Yun Zhou, M.D.","+86 20 87343105","+8618520122069","zhouyun@sysucc.or.cn",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":57,"coordinates":58},"Point",[59,60],113.25,23.11667,{"lat":60,"lon":59},[63,66],{"name":64,"role":39,"phone":40,"phoneExt":23,"email":65},"Chun-Yan Chen","chenchuny@sysucc.org.cn",{"name":38,"role":67,"phone":23,"phoneExt":23,"email":23},"PRINCIPAL_INVESTIGATOR",{"type":67,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Jihong Liu","Professor","100642400","phase-2-iparomlimab-and-tuvonralimab-plus-paclitaxel-and-platinum-as-neoadjuvant-therapy-for-locally-advanced-cervical-cancer-100642400",false,"NCT07646301","Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer","Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer: A Prospective Single-Arm Phase II Trial","QUARTZ-CC","Inclusion Criteria:\n\n1. Age 18 to 70 years.\n2. Histologically or cytologically confirmed cervical cancer, FIGO stage IB3 or IIA2.\n3. Imaging findings showing pelvic lymph node short-axis diameter \\\u003C 1.5 cm and para-aortic lymph node short-axis diameter \\\u003C 1.5 cm.\n4. Pathological diagnosis of cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n5. No prior anti-tumor therapy.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n\nExclusion Criteria:\n\n1. Presence of other concurrent malignancies.\n2. Pregnant or peripartum women.\n3. History of myocardial infarction or stroke, unstable angina, decompensated heart failure, or deep vein thrombosis.\n4. Presence of NCI-CTCAE version 5.0 grade ≥2 arrhythmia, any grade of atrial fibrillation, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.\n5. Active unresolved hepatitis, defined as progressive decrease in appetite, general weakness, nausea, acid reflux, aversion to oily foods, abdominal distension, or abnormal liver function with jaundice (e.g., scleral or urinary jaundice); for hepatitis B, HBV DNA \\> 1000 IU\u002FmL.\n6. Hepatic insufficiency (aspartate aminotransferase\u002Falanine aminotransferase \\> 2.5 × upper limit of normal).\n7. Renal insufficiency (serum creatinine \\> 2 × upper limit of normal).\n8. History of chronic pulmonary disease with restrictive respiratory dysfunction.\n9. History of major organ transplantation or autoimmune disease.\n10. History of severe mental illness or cerebral dysfunction.\n11. History of substance abuse or drug addiction.\n12. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (dose \\> 10 mg prednisone or equivalent) within 2 weeks prior to enrollment, with ongoing use.\n13. Coagulation abnormality (INR \\> 2.0, PT \\> 16 seconds), bleeding tendency, or ongoing thrombolytic or anticoagulant therapy (prophylactic low-dose aspirin and low-molecular-weight heparin are permitted).\n14. Congenital or acquired immunodeficiency (e.g., HIV infection).\n15. Receipt of inactivated vaccine within 30 days prior to the first dose of study treatment.\n16. Inability or unwillingness to provide written informed consent or comply with study requirements.","FEMALE","18 Years","70 Years",{"count":83,"type":84},103,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","Purpose:\n\nTo evaluate the efficacy and safety of neoadjuvant treatment with iparomlimab and tuvonralimab (QL1706), a dual PD1and CTLA4 bispecific antibody, in combination with paclitaxel and either cisplatin or carboplatin (TP\u002FTC regimen) for patients with locally advanced cervical cancer.\n\nEligibility Criteria:\n\nWomen aged 18 to 70 years with newly diagnosed, histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma), FIGO stage IB3 or IIA2, with no evidence of significant lymph node involvement (pelvic and paraaortic lymph nodes \\\u003C1.5 cm in short diameter), and who have not received any prior anticancer therapy.\n\nStudy Procedures:\n\nParticipants will receive up to 4 cycles of QL1706 plus TP\u002FTC chemotherapy (once every 3 weeks) prior to surgery. After 2 cycles, clinical assessment will be performed to evaluate tumor response. If tumor shrinkage is observed, treatment may continue for 2 additional cycles, followed by imaging evaluation. Depending on the response, participants with complete or partial response may undergo less extensive surgery (cervical conization plus sentinel lymph node biopsy) rather than standard radical hysterectomy. After surgery, participants who achieve a major pathological response will receive QL1706 maintenance therapy as a single agent for up to 8 additional cycles (once every 3 weeks). For participants with insufficient tumor response, standard radical hysterectomy will be performed. Postoperative adjuvant therapy (radiation or chemotherapy) will follow standard clinical guidelines.\n\nPrimary and Secondary Objectives:\n\nThe primary endpoint is the pathological complete response (pCR) rate in the resected tissue following neoadjuvant treatment. Secondary endpoints include safety (treatment related adverse events), objective response rate (ORR), 3 years overall survival, 3 years disease free survival, and quality of life.\n\nStudy Duration:\n\nTotal participation time depends on treatment response and surgical scheduling, with an expected duration of approximately 9 to 12 months (including neoadjuvant treatment, surgery, and potential maintenance therapy).",[90,91],"Uterine Cervical Neoplasms","Locally Advanced",[93,94,95,96,97,77],"Locally advanced cervical cancer","QL1706","Neoadjuvant chemoimmunotherapy","Pathological complete response","Phase II Single-arm Prospective study","2026-06-09",{"date":100,"type":101},"2026-06-12","ACTUAL",{"date":103,"type":84},"2026-07-01",{"date":105,"type":84},"2029-07-01",{"name":5,"class":6},1]