[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649226":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":11,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":11,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adebrelimab Treatment","EXPERIMENTAL",null,[13],"Drug: Adebrelimab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Adebrelimab","Adebrelimab (1200 mg) is administered intravenously (IV) on Day 1 of each 21-day cycle (Q3W).\n\nNeoadjuvant Phase: Patients receive short-course radiotherapy (30 Gy in 6 fractions) concurrent with 2 cycles of Adebrelimab plus platinum-based chemotherapy (cisplatin or carboplatin).\n\nAdjuvant Phase: Following surgery, patients receive up to 3 additional cycles of Adebrelimab plus platinum. This is followed by maintenance therapy with Adebrelimab monotherapy (Q3W) for a total treatment duration of 1 year. High-risk patients (positive nodes\u002Fmargins) may receive additional radiotherapy as clinically indicated.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Qin Qin","CONTACT","+86-15950508512","shuizhuqq@njmu.edu.cn",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The Affiliated Hospital of Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","210000","China","CN",{"type":36,"coordinates":37},"Point",[38,39],118.77778,32.06167,{"lat":39,"lon":38},[42],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},{"type":44,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100649226","phase-2-neoadjuvant-short-course-hypofractionated-radiotherapy-plus-adebrelimab-and-platinum-chemotherapy-in-locally-advanced-cervical-cancer-a-single-arm-phase-ii-trial-100649226",false,"NCT07731828","Neoadjuvant Short-course Hypofractionated Radiotherapy Plus Adebrelimab and Platinum Chemotherapy in Locally Advanced Cervical Cancer: A Single-arm Phase II Trial","A Single-arm, Phase II Study of Short-course Hypofractionated Radiotherapy Combined With Adebrelimab and Single-agent Platinum Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n* Signed informed consent form prior to any study-specific procedure.\n\nFemale aged 18 to 80 years (inclusive) at the time of signing informed consent.\n\nHistopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n\nClinical staging of IB3-IIA2, or IIIA without parametrial invasion (according to FIGO 2018 staging system); no pelvic lymph node metastasis confirmed by PET\u002FCT, and no evidence of distant metastasis.\n\nNo prior surgery, radiotherapy, or systemic anti-tumor therapy for locally advanced cervical cancer (LACC).\n\nAt least one measurable lesion meeting RECIST 1.1 evaluation criteria.\n\nECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.\n\nAdequate hematological, hepatic, and renal function within 14 days prior to enrollment (details to be confirmed in the full protocol).\n\nExclusion Criteria:\n\n* Pregnant or lactating women, or women who intend to become pregnant during the study period and are unwilling to use effective contraception.\n\nKnown hypersensitivity to adebrelimab, platinum-based drugs (cisplatin or carboplatin), or any component of the concomitant regimens.\n\nHistory of other malignant tumors within 5 years prior to enrollment, except for cured non-melanoma skin cancer or cervical intraepithelial neoplasia.\n\nUncontrolled severe cardiovascular disease (e.g., NYHA Class III or IV heart failure, unstable angina pectoris, uncontrolled arrhythmias, or myocardial infarction within 6 months).\n\nActive autoimmune disease requiring systemic immunosuppressive or corticosteroid therapy.\n\nKnown active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or uncontrolled HIV infection.\n\nUncontrolled severe infection requiring systemic antibiotic\u002Fantiviral therapy at enrollment.\n\nPrior participation in other clinical trials and received investigational drug within 4 weeks before enrollment.\n\nConcomitant disease or condition that, in the judgment of the Investigator, would place the subject at undue risk or interfere with the subject's participation in the trial or interpretation of trial results.","FEMALE","18 Years","80 Years",{"count":56,"type":57},35,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","Brief Summary\n\nA Phase II Single-Arm Clinical Trial of Short-Course Radiotherapy Combined with Adebrelimab and Platinum-Based Neoadjuvant Therapy for Locally Advanced Cervical Cancer\n\nBackground \\& Objective:\n\nThis is a single-center, single-arm, Phase II clinical trial. The primary objective is to evaluate the pathological complete response (pCR) rate (defined as ypT0N0) following neoadjuvant therapy with short-course radiotherapy (SCRT) combined with Adebrelimab (an anti-PD-L1 monoclonal antibody) and single-agent platinum chemotherapy in patients with locally advanced cervical cancer (LACC).\n\nStudy Design:\n\nPatients will receive SCRT followed by three cycles of neoadjuvant chemoimmunotherapy. After completion of neoadjuvant treatment, radical hysterectomy with pelvic lymphadenectomy (with or without para-aortic lymphadenectomy) will be performed.\n\nOutcome Measures:\n\nPrimary Endpoint: Pathological Complete Response (pCR) rate assessed by a central pathologist.\n\nSecondary Endpoints:\n\nObjective Response Rate (ORR) and R0 resection rate (per RECIST 1.1).\n\nEvent-Free Survival (EFS) and 2-year EFS rate.\n\nIncidence and severity of Treatment-Related Adverse Events (TRAEs, per NCI-CTCAE v5.0) and surgical complications (per Clavien-Dindo classification).\n\nFeasibility and implementation rate of different adjuvant treatment strategies based on postoperative risk stratification.\n\nDepth of response (major pathological response, MPR).\n\nInclusion Criteria:\n\nKey eligibility criteria include:\n\nNewly diagnosed, histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.\n\nClinical stage IB3-IIA2 or IIIA (without parametrial invasion) per FIGO 2018 staging.\n\nNo evidence of extrapelvic lymph node metastasis or distant metastasis (confirmed by PET\u002FCT or enhanced CT).\n\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.",[63],"Cervical Neoplasms","2026-07-23",{"date":66,"type":67},"2026-07-28","ACTUAL",{"date":69,"type":57},"2026-08-01",{"date":71,"type":57},"2028-08-01",{"name":5,"class":6},1]