[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548395":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":45,"locations":55,"responsibleParty":85,"collaborators":28,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":28,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":28,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":58,"whyStopped":28,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant therapy group","EXPERIMENTAL","Patients in the neoadjuvant group received neoadjuvant therapy prior to surgery (two cycles of HAIC combined with Tislelizumab and Lenvatinib), and adjuvant therapy (Tislelizumab for 8 cycles) after surgery.",[13,14,15,16],"Procedure: Hepatic arterial infusion chemotherapy","Drug: Lenvatinib","Drug: Tislelizumab","Procedure: Liver resection",{"label":18,"type":19,"description":20,"interventionNames":21},"Direct liver resection group","ACTIVE_COMPARATOR","Patients in the control group underwent liver resection directly and received adjuvant therapy (Tislelizumab for 8 cycles) after surgery.",[16,15],[23,29,34,38,42],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Hepatic arterial infusion chemotherapy","Patients in the neoadjuvant group received two cycles of neoadjuvant hepatic arterial infusion chemotherapy (HAIC, adoption of the FOFOLX6 program, Folinic acid+5-fluorouracil+Oxaliplatin, 21 days between second HAIC treatments with a window of ±3 days)",[9],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DRUG","Lenvatinib","Patients in the neoadjuvant therapy group received Lenvatinib before surgery(Len was started before HAIC treatment, discontinued during HAIC treatment, and discontinued approximately two weeks before surgery, Oral 8 mg or 12mg once a day depending body weight).",[9],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"Tislelizumab","Patients in the neoadjuvant therapy group received two cycles of Tislelizumab therapy before surgery (First treatment with Tislelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later)",[9],{"type":24,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Liver resection","Patients in the neoadjuvant therapy group were evaluated for tumor status and surgical safety after neoadjuvant therapy, and eligible patients subsequently underwent surgical resection. Patients in the direct surgery group underwent liver resection.",[18,9],{"type":30,"name":35,"description":43,"armGroupLabels":44,"otherNames":28},"Given the high risk of postoperative recurrence, patients in both groups received adjuvant Tis therapy (every 21 days for 8 cycles) starting about one month after surgery.",[18,9],[46,51],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":50},"WanGuang Zhang","CONTACT","13886195965","wgzhang@tjh.tjmu.edu.cn",{"name":52,"role":48,"phone":53,"phoneExt":28,"email":54},"xiaoping Chen","027-83663400","chenxpchenxp@163.com",[56,73],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Huapeng Sun","RECRUITING","Xiangyang","Hubei","430000","China","CN",{"type":65,"coordinates":66},"Point",[67,68],112.14479,32.0422,{"lat":68,"lon":67},[71],{"name":57,"role":48,"phone":28,"phoneExt":28,"email":72},"1255687614@qq.com",{"facility":74,"status":58,"city":75,"state":76,"zip":28,"country":62,"countryCode":63,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Enyu Liu","Jinan","Shandong",{"type":65,"coordinates":78},[79,80],116.99722,36.66833,{"lat":80,"lon":79},[83],{"name":74,"role":48,"phone":28,"phoneExt":28,"email":84},"liuenyu@163.com",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Chen Xiaoping","Professor","100548395","phase-2-neoadjuvant-therapy-in-patients-with-resectable-hcc-screened-by-a-multimodal-deep-learning-model-100548395",false,"NCT06420440","Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model","Efficacy and Safety of Neoadjuvant HAIC Combined With Tislelizumab and Lenvatinib in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model: a Multicenter Randomized Controlled Trial.","Inclusion Criteria:\n\n1. Aged 18-75.\n2. No previous local or systemic treatment for hepatocellular carcinoma.\n3. Child-Pugh liver function score ≤ 7.\n4. ECOG PS 0-1.\n5. No serious organic diseases of the heart, lungs, brain, kidneys, etc.\n6. Enhanced MRI determines that the tumor is technically resectable but at high risk for recurrence(BCLC-A tumor diameter more than or equal to 5cm; BCLC-B; BCLC-C) ; without distant metastasis.\n7. Pathologic type of hepatocellular carcinoma confirmed by puncture biopsy.\n8. Multimodal Deep Learning Model Screening Based on Pathology, Imaging, and Genetic Data Suggests Benefit from HAIC in Combination with Lenvatinib and PD-1 inhibitors.\n\nExclusion Criteria:\n\n1. Pregnant and lactating women.\n2. Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.).\n3. A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication\u002Fesophageal varices), as determined by the investigator.\n4. Active infection.\n5. Other significant clinical and laboratory abnormalities that affect the safety evaluation.\n6. Inability to follow the study protocol for treatment or follow up as scheduled.","ALL","18 Years","75 Years",{"count":100,"type":101},160,"ESTIMATED","INTERVENTIONAL",[104],"PHASE2","Primary liver cancer is one of the most common malignant tumors in the world, and about 80%\\~90% of primary liver cancers are pathologically characterized as hepatocellular carcinoma (HCC). Radical surgery is the main method for patients with HCC to obtain long-term survival. However, the early recurrence rate of high-risk HCC is very high, which seriously affects the overall therapeutic effect.",[107],"HCC",[109,110,111,112],"Hepatocellular carcinoma","Neoadjuvant tehrapy","recurrence","Deep learning","2025-04-28",{"date":115,"type":116},"2025-05-01","ACTUAL",{"date":118,"type":116},"2024-06-01",{"date":120,"type":101},"2027-05-31",{"name":87,"class":6},2]