protocolSection identificationModule nctId: NCT06333821, orgStudyIdInfo id: BPL-Nim-CC-3003, briefTitle: A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2030-04-01, completionDateStruct date: 2030-04-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Biotech Pharmaceutical Co., Ltd., class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy versus placebo combined with concurrent chemoradiotherapy in patients with locally advanced cervical squamous cell carcinoma.The primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival., conditionsModule conditions: Cervical Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a multicenter prospective, randomized, double-blind, placebo-controlled phase III trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: This study is double-blind and will blind both the investigator and the subjects. All participants in the study (including data managers and biostatisticians) will be unaware of treatment assignment (except blind statisticians)., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 460, type: ESTIMATED, armsInterventionsModule interventions name: Nimotuzumab, interventions name: Cisplatin, interventions name: External Beam Radiotherapy (EBRT), interventions name: Brachytherapy, interventions name: placebo for Nimotuzumab, outcomesModule primaryOutcomes measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed Blinded Independent Central Review (BICR), secondaryOutcomes measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by by the Investigator, secondaryOutcomes measure: 3-,5-Year Overall Survival (OS), secondaryOutcomes measure: 3-,5-Year Disease Free Survival(DFS), secondaryOutcomes measure: 3-,5-Year Locoregional Recurrence-Free Survival(LRRFS), secondaryOutcomes measure: 3-,5-Year Distant Metastasis-free Survival (DMFS), secondaryOutcomes measure: Tumor Regression Rate(TRR), secondaryOutcomes measure: Complete Response Rate, secondaryOutcomes measure: Complete Response Rate, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False