[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adjuvant-chemoradiotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adjuvant-chemoradiotherapy":25},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100625066","construction-and-clinical-validation-of-a-predictive-model-for-postoperative-adjuvant-therapy-in-hepatocellular-carcinoma-based-on-whole-slide-digital-pathological-images-and-deep-learning-100625066",false,"NCT07417800","Construction and Clinical Validation of a Predictive Model for Postoperative Adjuvant Therapy in Hepatocellular Carcinoma Based on Whole-Slide Digital Pathological Images and Deep Learning","Inclusion Criteria:\n\n* Histopathologically confirmed hepatocellular carcinoma;\n* Aged more than 18 years;\n* Underwent radical resection of primary liver cancer (R0 resection);\n* Availability of postoperative H\\&E-stained paraffin embedded tissue sections suitable for digital whole-slide imaging;\n* Had complete and accessible clinicopathological data and follow-up data;\n* Has complete and evaluable preoperative and postoperative contrast-enhanced CT or MRI imaging with standardized scanning parameters and no severe artifacts, meeting the quality requirements for radiomic and artificial intelligence analysis.\n\nExclusion Criteria:\n\n* Significant missing clinical or follow-up data;\n* Concurrent primary malignancy in other organs;\n* Positive surgical margin (R1 or R2 resection);\n* Tissue sections of poor quality (e.g., severe fading, folding, damage) unsuitable for digital scanning or analysis;","ALL","18 Years",{"count":18,"type":19},11000,"ESTIMATED","OBSERVATIONAL","Hepatocellular carcinoma (HCC) is a high-mortality global malignancy with a heavy disease burden in China. Although curative surgical resection improves survival for early-stage HCC patients, the 5-year postoperative recurrence rate remains as high as 50%-70%. Postoperative adjuvant TACE and systemic TKIs are standard treatments for high-risk HCC, yet both therapies have prominent drawbacks, including limited response rates, unavoidable toxicities, and inconsistent clinical benefits. Current treatment decisions rely on conventional clinical and pathological features without precise biomarkers, leading to inadequate individualized therapy and wasted medical resources.\n\nTumor immune microenvironment and multimodal imaging-pathological features critically determine HCC treatment sensitivity. Artificial intelligence and deep learning based on preoperative radiomics and postoperative H\\&E whole-slide imaging (WSI) can capture hidden tumor biological characteristics and predict therapeutic responses. However, no validated multimodal AI model is available for predicting postoperative TACE and TKI treatment outcomes in HCC, lacking large-scale multicenter prospective evidence.\n\nThis study aims to construct and validate a multimodal deep learning model integrating preoperative contrast-enhanced CT\u002FMRI, postoperative WSI, pathological reports, and clinical data, to precisely identify HCC patients sensitive to postoperative adjuvant TACE or TKI therapy and optimize individualized treatment strategies.\n\nThis is a hybrid retrospective-training and prospective observational multicenter study with no clinical intervention. A total of 10,000 retrospective HCC surgical patients will be enrolled to develop an AI classification model for predicting responses to four postoperative treatment strategies: surgery alone, surgery plus TACE, surgery plus TACE combined with systemic therapy, and surgery plus exclusive systemic therapy. Subsequently, 1,000 eligible postoperative HCC patients will be prospectively and consecutively enrolled from 10-15 centers. The AI model will generate adjuvant therapy predictions without interfering with real clinical decisions. Patients will be divided into prediction-consistent and prediction-inconsistent cohorts based on the match between model predictions and actual treatments. Long-term follow-up will be performed to compare prognostic outcomes and validate the model's real-world performance and stability.\n\nKey inclusion criteria: histopathologically confirmed HCC; aged 18-75 years; received R0 curative resection; available qualified H\\&E-stained FFPE slides for digital scanning; complete clinical, pathological and follow-up data; high-quality preoperative contrast-enhanced CT\u002FMRI images eligible for AI analysis. Key exclusion criteria: prior preoperative anti-tumor therapy with unavailable baseline data; concurrent other primary malignancies; non-R0 resection; unqualified pathological slides or imaging data; severe missing clinical or follow-up information.",[23,24,25,26,27,28],"Hepatocellular Carcinoma (HCC)","Artificial Intelligent","Adjuvant Chemoradiotherapy","TACE","Lenvatinib","Liver Surgery",[23,24,26,30,25],"lenvatinib","RECRUITING","2026-06-07",{"date":34,"type":35},"2026-06-10","ACTUAL",{"date":37,"type":35},"2025-11-01",{"date":39,"type":19},"2029-12-01",{"name":41,"class":42},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":43},"100597853","phase-2-a-prospective-phase-ii-study-of-postoperative-concurrent-chemoradiotherapy-in-patients-with-intrahepatic-cholangiocarcinoma-100597853","NCT07063888","A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma","A Prospective Phase II Study of Adjuvant Concurrent Chemoradiotherapy With Simultaneous Integrated Boost Following Hepatectomy for Intrahepatic Cholangiocarcinoma With Narrow Margin or Nodal Involvement","Inclusion Criteria:\n\n* Age \\> 18 years, \\\u003C 80 years\n* Patients with primary surgical treatment\n* Postoperative pathology confirmed intrahepatic cholangiocarcinoma\n* Postoperative pathology showing narrow resection margin (\\\u003C1cm) or positive lymph nodes\n* R0\u002FR1 resection\n* Postoperative Child-Pugh score A5-B7\n* Patients meeting either of the following conditions must undergo preoperative or pre-radiotherapy PET-CT to exclude distant metastasis or lymph node metastasis beyond the region from the lower esophagus to the aortic bifurcation\n\n  1. Lymph node metastasis accounting for \\>50% of dissected nodes\n  2. Lymph node metastasis involving the paracardial region or below the renal vein level\n* Postoperative contrast-enhanced liver MRI to exclude Intrahepatic satellite nodules\n* Recovery from surgery with Eastern Cooperative Oncology Group performance status score of 0-2\n* Estimated life expectancy \\>3 months\n\nExclusion Criteria:\n\n* History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix\n* Had prior abdominal irradiation\n* Had prior liver transplantation\n* Had serious myocardial disease or renal failure\n* Had moderate or severe ascites with obvious symptoms 4 months after surgery\n* Duration from surgery ≥ 4 months","80 Years",{"count":53,"type":19},66,"INTERVENTIONAL",[56],"PHASE2","This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant concurrent chemoradiotherapy with simultaneous integrated boost following hepatectomy for intrahepatic cholangiocarcinoma with narrow margin (\\\u003C1cm) or nodal involvement. Eligibility patients will receive IMRT or VMAT. The prescription dose to high-risk area of tumor bed or positive lymph node was planned at 55-60Gy and the prescription dose to lymphatic drainage regions was planned at 40-45Gy in 20-25 fractions. During radiotherapy, patients will concurrently receive capecitabine (1600 mg\u002Fm² on days 1-14, every 21 days for 2 cycles). After radiotherapy, maintenance therapy with capecitabine will continue (2000 mg\u002Fm² on days 1-14, every 21 days for 6 cycles). For patients who cannot tolerate capecitabine, S-1 will be used as an alternative. The primary endpoint is 2-year recurrence-free survival. The secondary endpoints are 2-year overall survival, local-regional control rate and incidence of grade 3 or higher adverse events.",[59,25,60,61],"Intrahepatic Cholangiocarcinoma (Icc)","Narrow Margin","Lymph Node Involvement","2025-07-11",{"date":64,"type":35},"2025-07-14",{"date":66,"type":35},"2025-05-16",{"date":68,"type":19},"2028-05-15",{"name":70,"class":42},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences"]