[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572004":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":67,"collaborators":25,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":25,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":51,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8,15],{"label":9,"type":10,"description":9,"interventionNames":11},"Serplulimab plus chemoradiotherapy group","EXPERIMENTAL",[12,13,14],"Drug: Serplulimab","Drug: Chemotherapy","Radiation: radiotherapy",{"label":16,"type":17,"description":16,"interventionNames":18},"chemoradiotherapy group","PLACEBO_COMPARATOR",[13,14],[20,26,30],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Serplulimab","intravenous infusion of 300 mg, administered every 3 weeks as one cycle, on the first day of each cycle, with a maximum treatment duration of 2 years (up to 35 treatment cycles)",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Chemotherapy","Cisplatin: Administered by intravenous infusion during concurrent chemoradiotherapy at a dose of 30-40 mg\u002Fm² once weekly for only 5-6 treatment cycles; during sequential chemoradiotherapy, administered at 60-75 mg\u002Fm² on the first and second days of each cycle, once every 3 weeks (21 days) for only 4 treatment cycles.\n\nPaclitaxel: Nab-paclitaxel administered by intravenous infusion at a dose of 135-175 mg\u002Fm² on the first day of each cycle, once every 3 weeks (21 days) for only 4 treatment cycles.",[9,16],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":25},"RADIATION","radiotherapy","Pelvic external beam radiation therapy at a dose of 1.8 Gy per fraction or 2 Gy per day, 5 times per week, with a total dose of 45-50 Gy.",[9,16],[36],{"name":37,"affiliation":5,"role":38},"Maobin Meng, Dr.","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":25,"email":43},"CONTACT","+86 15202231270","mmeng@tmu.edu.cn",{"name":45,"role":41,"phone":46,"phoneExt":25,"email":47},"Ying Chen, Dr.","+86 13132032398","lychenying2004@126.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Tianjin Medical University Cancer Institute & Hospital","RECRUITING","Tianjin","Tianjin Municipality","300060","China","CN",{"type":58,"coordinates":59},"Point",[60,61],117.17667,39.14222,{"lat":61,"lon":60},[64,65],{"name":37,"role":41,"phone":42,"phoneExt":25,"email":43},{"name":66,"role":41,"phone":46,"phoneExt":25,"email":47},"Ying Chen",{"type":68,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100572004","phase-2-serplulimab-with-chemoradiotherapy-for-postoperative-cervical-cancer-with-risk-factors-100572004",false,"NCT06727617","Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors","Serplulimab Plus Chemoradiotherapy vs Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer Patients With Multiple Risk Factors: A Randomized, Open-Label, Phase II Clinical Trial","Inclusion Criteria:\n\n* Voluntarily participate in the clinical study: Fully understand and be informed about the study, and sign the informed consent form (ICF); willing to comply with and capable of completing all trial procedures.\n* Female aged ≥18 years and ≤65 years at the time of signing the ICF.\n* ECOG PS score of 0 or 1.\n* Positive PD-L1 status (CPS ≥1).\n* Diagnosed with cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n* FIGO (International Federation of Gynecology and Obstetrics) stage of IB1, IB2, IIA1, or IIA2, and patients judged by the investigator to benefit from radical surgery and\u002For adjuvant therapy.\n* Have undergone radical hysterectomy (Piver classification) and pelvic lymphadenectomy of type II or III.\n* Postoperative pathological examination confirms at least two adverse factors, which may include: Lymph node metastasis; Positive parametrial or positive resection margins; Lymphovascular space invasion; Deep stromal invasion;\n* Patients must meet the following hematological, renal, and liver function criteria: Absolute neutrophil count of at least 1.5 × 10⁹\u002FL; Platelet count of at least 100 × 10⁹\u002FL; Total bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels not exceeding 1.5 times the upper limit of normal; Creatinine levels not exceeding the upper limit of normal.\n* Female participants must have a negative serum pregnancy test within 14 days prior to treatment and agree to use effective contraception during the treatment period and for 6 months afterward; breastfeeding is prohibited during treatment.\n* Willing and able to comply with the trial and follow-up procedures.\n\nExclusion Criteria:\n\n* Patients with unresectable residual tumors.\n* Histologically confirmed diagnosis of cervical small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma.\n* Patients who have previously received pelvic radiotherapy.\n* History of other untreated malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ.\n* Presence of any active or known autoimmune disease.\n* History of inflammatory\u002Fautoimmune diseases requiring steroid treatment, or currently suffering from inflammatory\u002Fautoimmune diseases that require steroid treatment.\n* Diseases requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization.\n* History of thromboembolic events (venous or arterial) occurring within 6 months prior to enrollment.\n* Poorly controlled clinical symptoms or conditions related to heart disease.","ALL","18 Years","65 Years",{"count":80,"type":81},134,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk Factors",[87],"Cervical Cancers",[89,90,91,32],"cervical cancer","high risk","immunotherapy","2026-01-04",{"date":94,"type":95},"2026-01-06","ACTUAL",{"date":97,"type":95},"2024-11-19",{"date":99,"type":81},"2026-12-31",{"name":5,"class":6},1]