[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506310":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Suzhou Municipal Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","Eligible subjects were assigned to high-risk or medium-risk groups based on Peter's criteria and Sedlis criteria. Patients with a high-risk classification or MRDc0 (+) status received a treatment consisting of conventional pelvic concurrent chemoradiotherapy, adjuvant chemotherapy, four courses of immunotherapy, continued immunotherapy with MRDIn(+), and follow-up monitoring with MRDIn(-)",[13],"Drug: Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B","Patients deemed intermediate risk and with MRDc0 (-) status received concurrent chemoradiotherapy in the small pelvic target volume, four courses of immunotherapy, continued immunotherapy with MRDIn(+), and follow-up monitoring with MRDIn(-)",[18],"Drug: Chemoradiotherapy (small pelvic) + Zimberelimab",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab","* Radiation therapy:\n\n  1\\. Irradiation mode and dose: 6MV-X-ray (6Megavoltage-X-ray), IMRT or RapidArc-IMRT were used for external radiotherapy. External radiotherapy dose: PTV (Planning Target Volume) 45-50Gy\u002F25 times.\n* Chemotherapy:\n\n  1. Concurrent chemotherapy: Cisplatin monotherapy: DDP 75 mg\u002Fm2 for 3 days, q3w. Carboplatin or nedaplatin may be used in patients that cannot tolerate cisplatin.\n  2. Adjuvant chemotherapy: After the concurrent chemoradiotherapy, 4 cycles of consolidation chemotherapy plus immunotherapy are recommended for patients with high risk or MRDc0 (+). Recommended chemotherapy regimen: liposome paclitaxel 135mg\u002Fm2 d1 +DDP 25 mg\u002Fm2 D1-3, Q21.\n* Zimberelimab injection:\n\n  240 mg, IV, q3w. Start the drug one day before the start of postoperative radiotherapy.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Chemoradiotherapy (small pelvic) + Zimberelimab","Radiation therapy:\n\n1\\. Target volume of radiotherapy for small pelvis: CTVp includes tumor bed area, paracentral area and part of vagina; CTVn includes bilateral internal iliac, external iliac and obturator lymphatic drainage areas. Upper boundary to sacroiliac joint level, lower boundary to 2cm below vaginal stump.\n\nChemotherapy:\n\nConcurrent chemotherapy: Cisplatin monotherapy: DDP 75 mg\u002Fm2 for 3 days, q3w. Carboplatin or nedaplatin may be used in patients that cannot tolerate cisplatin.\n\nAdjuvant chemotherapy: After the concurrent chemoradiotherapy, 4 cycles of adjuvant immunotherapy are recommended for patients in good general condition (ECOG: 0-1) with medium risk and MRDc0 (-).\n\nZimberelimab injection: 240 mg, IV, q3w. Start the drug one day before the start of posterior radiotherapy.",[15],[31],{"name":32,"affiliation":33,"role":34},"jing xue","The Affiliated Suzhou Hospital of Nanjing Medical University","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","(+86)13771734347","jxue@njmu.edu.cn",[41],{"facility":33,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Suzhou","Jiangsu","215001","China","CN",{"type":49,"coordinates":50},"Point",[51,52],120.59538,31.30408,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":25,"email":39},"Jing Xue","13771734347",{"type":34,"investigatorFullName":32,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Associate chief physician","100506310","phase-2-optimization-of-postoperative-adjuvant-therapy-for-cervical-cancer-based-on-mrdminimal-residual-disease-100506310",false,"NCT05872724","Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD(Minimal Residual Disease)","Clinical Study on Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD","Inclusion Criteria:\n\n1. Patients with histopathological and clinical (FIGO 2018) stage ⅠB2 \\~II A2 cervical cancer.\n2. Above the age of 18.\n3. General status: ECOG score 0-2.\n4. Be able to understand the research scheme, voluntarily participate in the study, and sign the informed consent.\n5. Good compliance, able to cooperate with the collection of specimens at each node and provide corresponding clinical information.\n\nExclusion Criteria:\n\n1. Suffering from other malignant tumors.\n2. Do not receive the specified treatment or change the treatment regimen before the disease progresses.\n3. The study cannot be followed up according to the defined clinical follow-up period.\n4. Unable to accept or provide CT or other designated therapeutic evaluation means.\n5. Have an autoimmune disease.","FEMALE","18 Years",{"count":70,"type":71},32,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","This study is a prospective cohort clinical trial that aims to investigate the safety and efficacy of a combined chemoradiotherapy and immunotherapy treatment for early postoperative cervical cancer. Specifically, this study seeks to evaluate the ability of MRD-based screening to detect and monitor changes in MRD status at different stages of treatment, its potential for use in monitoring patient recurrence rates and in prognosis evaluation. In addition, this study will investigate the safety and effectiveness of chemoradiotherapy combined with immunotherapy as a postoperative adjuvant therapy for patients identified to be at risk of early cervical cancer based on MRD screening.",[77],"Cervical Cancer","2023-05-14",{"date":80,"type":81},"2023-05-24","ACTUAL",{"date":83,"type":81},"2023-01-16",{"date":85,"type":71},"2028-12-30",{"name":5,"class":6},1]