[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"objective-response-rate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:objective-response-rate":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100626049","adebrelimab-combined-with-chemotherapy-for-the-esophageal-squamous-cell-carcinoma-100626049",false,"NCT07430579","Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma","A Single-arm, Single-center, Exploratory Clinical Study of Adebrelimab Combined With Neoadjuvant Chemotherapy for the Treatment of Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Patients must have a histopathologically confirmed diagnosis of Esophageal Squamous Cell Carcinoma （ESCC）.\n2. Eligible patients are those with stage II\u002FIII disease according to the AJCC\u002FUICC 8th edition Tumor-Node-Metastasis (TNM) staging system, presenting with cT1-3N1-2M0 or cT3-4aN0M0 disease.\n3. Patients could tolerate chemotherapy and surgery after evaluation and MDT discussion, accepting the clinical trial protocol.\n\nExclusion Criteria:\n\n1. Patients with a history of other uncured malignancies within the past 5 years, individuals with ongoing or a history of autoimmune diseases, and those who have received any prior anti-tumor therapy.\n2. Patients' cardio- pulmonary function could not tolerate surgery or chemotherapy, or don't accept the clinical trial protocol.","ALL","18 Years","80 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a prospective, single-arm, phase II exploratory clinical trial. The primary endpoint of this study is to evaluate the pathological complete response (pCR) rate after surgery and to assess the safety of neoadjuvant therapy with adebrelimab combined with platinum-based chemotherapy in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) at the Second Qilu Hospital of Shandong University.\n\nThe primary endpoint of this clinical trial is the pathological complete response (pCR) rate, defined as the absence of residual viable tumor cells in the resected specimen, including lymph nodes (ypT0N0M0). Secondary endpoints include the major pathological response (MPR) rate, objective response rate (ORR), treatment-related adverse events (TRAEs) and immune-related adverse events (irAEs), as well as quality of life (QOL) assessments during neoadjuvant immunochemotherapy (nICT). MPR is defined as less than 10% residual viable tumor cells in the primary tumor bed following neoadjuvant therapy and resection. ORR represents the percentage of patients achieving complete response (CR) or partial response (PR). Other secondary measures include the tumor downstaging rate, surgery rate, R0 resection rate (defined as no residual tumor at the resection margins), and perioperative complication rate. Furthermore, overall survival (OS) and relapse-free survival (RFS) are considered exploratory endpoints in this study. By evaluating these diverse endpoints, the investigators aim to comprehensively assess the efficacy, safety, and overall impact of the nICT approach in patients with locally advanced resectable ESCC. Additionally, it is planned to construct 20 pairs of esophageal squamous cell carcinoma and adjacent normal esophageal squamous epithelial organoids, laying the groundwork for future in-depth exploration of the mechanisms underlying esophageal carcinogenesis and progression, as well as functional studies of specific genes.",[27,28,29,30],"Pathological Complete Remission","Objective Response Rate","Immune-related Adverse Events","Quality of Life","RECRUITING","2026-02-23",{"date":34,"type":35},"2026-02-24","ACTUAL",{"date":37,"type":35},"2024-12-09",{"date":39,"type":21},"2028-06-30",{"name":41,"class":42},"The Second Hospital of Shandong University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"100604162","phase-2-neoadjuvant-immunochemotherapy-and-postoperative-adjuvant-immunotherapy-for-head-and-neck-squamous-cell-carcinoma-invading-the-skull-base-100604162","NCT07145931","Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Immunotherapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base","Tislelizumab Combined With Chemotherapy for Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Therapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base: A Prospective, Single-arm, Phase II Clinical Study","Inclusion Criteria:\n\n* Age 18 to 80 years, regardless of gender;\n* Histologically confirmed squamous cell carcinoma (including gingiva, buccal mucosa, palate, oropharynx, maxillary sinus, or maxilla\u002Fmandible) with radiological evidence of skull base invasion;\n* Measurable tumor lesions (meeting RECIST v1.1 criteria);\n* Treatment-naïve primary T4b-stage patients (N any, per AJCC 8th Edition, 2017);\n* ECOG PS score: 0-1;\n* Medically fit for surgery and chemotherapy, with no surgical contraindications;\n* Women of childbearing potential (18-49 years) must have a negative pregnancy test within 7 days before treatment. Sexually active men and women must agree to use effective contraception during the trial and for 3 months after treatment cessation;\n* Willing to provide written informed consent and comply with scheduled follow-ups, treatments, lab tests, and other study requirements.\n\nExclusion Criteria:\n\n* Previous anti-tumor treatments including chemotherapy, radiotherapy, or immunotherapy; Refusal to sign informed consent;\n* Patients who refuse the study treatment protocol; patients unable to complete treatment as planned; or patients unable to comply with regular follow-up due to psychological, social, familial or geographical reasons;\n* Patients with known allergies to any study medications;\n* Patients with poor systemic conditions unfit for treatment: as determined by routine tests (complete blood count, blood biochemistry, ECG, chest X-ray, etc.). Poor systemic conditions include: hemoglobin \\\u003C60g\u002FL, WBC \\\u003C3.0×10⁹\u002FL, platelets \\\u003C80×10⁹\u002FL, or serum creatinine \\>133μmol\u002FL - such patients may be recommended for conservative treatment;\n* Patients with autoimmune diseases requiring long-term immunosuppressive or corticosteroid therapy;\n* Pregnant or lactating women (pregnancy testing should be considered for sexually active women of childbearing potential);\n* Patients with current or previous malignancies (except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or papillary thyroid carcinoma);\n* Participation in other clinical trials within 30 days prior to enrollment;\n* Other conditions that may compromise patient safety or compliance as assessed by investigators, including: severe comorbidities (including psychiatric disorders), significantly abnormal laboratory results, or other high-risk familial\u002Fsocial factors.",{"count":52,"type":21},24,[54],"PHASE2","This prospective, single-arm, Phase II clinical trial aims to evaluate the efficacy and safety of tislelizumab combined with chemotherapy as neoadjuvant therapy and postoperative adjuvant immunotherapy in patients with skull base-invading head and neck squamous cell carcinoma. The primary objectives are to address the following questions:\n\n* What are the objective response rate and pathological response of tislelizumab combined with chemotherapy as neoadjuvant therapy in patients with skull base-invading head and neck squamous cell carcinoma?\n* Can neoadjuvant therapy convert unresectable skull base-invading head and neck squamous cell carcinoma into a resectable condition?\n* Can adjuvant immunotherapy after neoadjuvant therapy prolong patients' recurrence-free survival and overall survival? The researchers will administer neoadjuvant therapy (tislelizumab combined with chemotherapy) and adjuvant immunotherapy to patients with skull base-invading head and neck squamous cell carcinoma and assess the treatment's efficacy and safety.\n\nParticipants will:\n\n* Receive neoadjuvant therapy every 3 weeks (tislelizumab 200mg on Day 1, nab-paclitaxel 260mg\u002Fm² on Day 1, cisplatin 75mg\u002Fm² on Days 1-3) for 3 cycles.\n* Undergo surgical treatment within 3 weeks after completing neoadjuvant therapy.\n* Receive (chemo)radiotherapy 4-6 weeks after surgery.\n* Receive adjuvant immunotherapy (tislelizumab 200mg) every 3 weeks after (chemo)radiotherapy for 8 cycles.",[57,58,59,28],"Head and Neck Cancer Squamous Cell Carcinoma","Skull Base--Cancer","Neoadjuvant Chemoimmunotherapy",[57,58,59,61],"Objective response rate","NOT_YET_RECRUITING","2025-08-21",{"date":65,"type":35},"2025-08-28",{"date":67,"type":21},"2025-09-20",{"date":69,"type":21},"2029-09-20",{"name":71,"class":42},"Sun Yat-sen University"]