[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654471":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":16,"studyPopulation":16,"armGroups":37,"interventions":43,"overallOfficials":16,"centralContacts":49,"locations":55,"responsibleParty":71,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":16,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":16,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":100,"whyStopped":16,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Hebei Medical University Fourth Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Pathological Complete Response (pCR) rate","Pathological Complete Response (pCR) rate: Proportion of patients with no residual invasive tumor in primary tumor bed and sampled lymph nodes (ypT0\u002FTis ypN0) after neoadjuvant therapy","Assessed via surgical pathology (4-6 weeks post-neoadjuvant therapy)",[14,18,20,23,26,28],{"measure":15,"description":16,"timeFrame":17},"Major Pathological Response (MPR) rate",null,"Perioperative",{"measure":19,"description":16,"timeFrame":17},"R0 resection rate",{"measure":21,"description":16,"timeFrame":22},"Objective Response Rate (ORR) per RECIST v1.1","Assessed at baseline and pre-surgery",{"measure":24,"description":16,"timeFrame":25},"Event-Free Survival (EFS)","Follow-up every 3 months for 2 years, then every 6 months up to 5 years",{"measure":27,"description":16,"timeFrame":25},"Overall Survival (OS)",{"measure":29,"description":16,"timeFrame":30},"Safety: Incidence of adverse events (AEs), serious AEs (SAEs), and immune-related AEs (irAEs)","From initiation of treatment to 30 days post-last dose (or 90 days for SAEs)",{"allocation":32,"interventionModel":33,"interventionModelDescription":16,"primaryPurpose":34,"observationalModel":16,"timePerspective":16,"maskingInfo":35},"NA","SINGLE_GROUP","TREATMENT",{"masking":36,"maskingDescription":16,"whoMasked":16},"NONE",[38],{"label":39,"type":40,"description":16,"interventionNames":41},"Paclitaxel polymer micelles and cisplatin combined with sintilimab","EXPERIMENTAL",[42],"Drug: Paclitaxel polymer micelles for injection and cisplatin combined with sintilimab",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":16},"DRUG","Paclitaxel polymer micelles for injection and cisplatin combined with sintilimab","1. Sindilimab : 200 mg, Q3W, intravenous infusion, D1 ;\n2. Paclitaxel polymeric micelles : 300 mg\u002Fm2 ; q3W, intravenous infusion, D1 ;\n3. Cisplatin : 75 mg\u002Fm2 ; q3W ; intravenous infusion, D1 ;",[39],[50],{"name":51,"role":52,"phone":53,"phoneExt":16,"email":54},"Ziqiang Tian","CONTACT","+8618538881000","tizq12@vip.163.com",[56],{"facility":57,"status":16,"city":58,"state":59,"zip":16,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"The Fourth Hospital of Hebei Medical University","Hebei","Shijiazhuang","China","CN",{"type":63,"coordinates":64},"Point",[65,66],116.17968,25.93504,{"lat":66,"lon":65},[69],{"name":51,"role":52,"phone":70,"phoneExt":16,"email":54},"+8618531118000",{"type":72,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR",[74],{"name":75,"class":76},"Shanghai Yizhong Pharmaceutical Co., Ltd.","INDUSTRY","100654471","phase-2-paclitaxel-polymeric-micelles-and-cisplatin-plus-sintilimab-as-neoadjuvant-therapy-for-resectable-locally-advanced-esophageal-squamous-cell-carcinoma-100654471",false,"NCT07799077","Paclitaxel Polymeric Micelles and Cisplatin Plus Sintilimab as Neoadjuvant Therapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma","Paclitaxel Polymeric Micelles and Cisplatin Plus Sintilimab as Neoadjuvant Therapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-arm, Multicenter, Prospective Phase II Clinical Trial","Inclusion Criteria:\n\n1. Written informed consent was signed before the implementation of any test-related procedures ;\n2. Age 18-75 years ;\n3. Esophageal squamous cell carcinoma confirmed by histopathology ;\n4. Resectable thoracic cT1b-2N1-3M0 or cT2-3N0M0 ;\n5. No anti-tumor treatment has been received ;\n6. ECOG PS 0-1 ;\n7. Expected survival ≥ 3 months ;\n8. At least one measurable lesion per RECIST v1.1;\n9. Adequate organ function (hematology, liver, kidney, coagulation, thyroid, myocardial enzymes) ;\n10. For women of childbearing age, a negative urine or serum pregnancy test should be performed within three days prior to the first study drug administration ( day 1 of the first cycle ). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is required. Women of non-fertility age were defined as at least 1 year after menopause, or had undergone surgical sterilization or hysterectomy ;\n11. If there is a risk of conception, all subjects ( male or female ) are required to use contraception with an annual failure rate of less than 1 % throughout the treatment period up to 120 days after the last study drug administration ( or 180 days after the last study drug administration ).\n\nExclusion Criteria:\n\n1. High risk of tracheoesophageal fistula or aortoesophageal fistula\n2. Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy\n3. Participation in another interventional clinical trial within 4 weeks before the first dose\n4. History of other active malignancies (except cured low-risk tumors, adequately treated non-melanoma skin cancer, or carcinoma in situ)\n5. Active uncontrolled hepatitis B\u002FC infection\n6. Uncontrolled systemic diseases (e.g., heart failure NYHA ≥II, interstitial lung disease, active autoimmune diseases requiring systemic immunosuppression)\n7. Allergy to study drugs or excipients\n8. Uncontrolled third-space effusion (e.g., pleural\u002Fpericardial effusion)\n9. Pregnant or lactating women","ALL","18 Years","75 Years",{"count":88,"type":89},32,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","Locally advanced Esophageal Squamous Cell Carcinoma (ESCC) has poor prognosis with standard therapies. Neoadjuvant immunochemotherapy improves pathological response rates, but optimal regimens remain undefined. Paclitaxel polymeric micelles offer enhanced tumor targeting (EPR effect) and reduced toxicity vs. conventional paclitaxel formulations, with no need for premedication. This single-arm, prospective trial evaluates the efficacy and safety of neoadjuvant sintilimab combined with paclitaxel polymeric micelles and cisplatin in resectable locally advanced ESCC.",[95],"Esophageal Squamous Cell Carcinoma",[97,98,99],"Esophageal squamous cell carcinoma","Locally advanced resectable","Paclitaxel Polymeric Micelles","NOT_YET_RECRUITING","2026-08-31",{"date":103,"type":104},"2026-09-02","ACTUAL",{"date":106,"type":89},"2026-09-01",{"date":108,"type":89},"2029-10-01",{"name":5,"class":6},1]