[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540059":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":33,"responsibleParty":44,"collaborators":33,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":33,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":33,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":72,"whyStopped":33,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":33},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant therapy group","EXPERIMENTAL","Patients in the neoadjuvant therapy group received neoadjuvant therapy before undergoing liver resection.",[13],"Drug: HAIC + Tirelizumab +lenvatinib +liver resection",{"label":15,"type":16,"description":17,"interventionNames":18},"Direct surgical resection group","ACTIVE_COMPARATOR","Patients in the control group undergoing liver resection directly.",[19],"Procedure: liver resection",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","HAIC + Tirelizumab +lenvatinib +liver resection","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) + Tirelizumab (First treatment with Tirelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later)+ lenvatinib (Oral 8 mg or 12mg once a day depending body weight). Assessment of tumor status and surgical safety after receiving neoadjuvant therapy, and eligible patients then underwent surgical resection.",[9],[27],"Non",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"PROCEDURE","liver resection","Direct liver resection or laparoscopic liver resection depending on tumor status.",[15],null,[35],{"name":36,"affiliation":5,"role":37},"Xiaoping Chen","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":33,"email":43},"WanGuang Zhang","CONTACT","+8613886195965","wgzhang@tjh.tjmu.edu.cn",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","Chen Xiaoping","Professor","100540059","phase-4-efficacy-and-safety-of-neoadjuvant-therapy-in-patients-with-resectable-hcc-screened-by-a-multimodal-deep-learning-model-100540059",false,"NCT06311916","Efficacy and Safety of Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model.","Efficacy and Safety of Neoadjuvant HAIC Combined With Immunotherapy and Targeted Therapy in Patients With Resectable Intermediate-stage 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 stage is intermediate (BCLC stage B) and is safe for radical hepatectomy.\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. Tumor distribution in two liver lobes, diffuse growth, or other reasons why radical R0 resection is not possible.\n3. 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.).\n4. 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.\n5. Active infection.\n6. Other significant clinical and laboratory abnormalities that affect the safety evaluation.\n7. Inability to follow the study protocol for treatment or follow up as scheduled.","ALL","18 Years","75 Years",{"count":59,"type":60},312,"ESTIMATED","INTERVENTIONAL",[63],"PHASE4","Primary liver cancer is one of the most common malignant tumors in the world, and more than 90% of primary liver cancers are pathologically characterized as hepatocellular carcinoma (HCC). The intermediate stage (BCLC-B) HCC is highly heterogeneous, and there is no consensus on the treatment of this stage of the tumor in Western and Eastern countries. New tools are urgently needed to guide the choice of treatment options for patients with this stage of the tumor in order to reduce the risk of postoperative recurrence and the overall survival rate.",[66],"HCC",[68,69,70,71],"Hepatocellular carcinoma","Neoadjuvant tehrapy","recurrence","Deep learning","NOT_YET_RECRUITING","2024-03-09",{"date":75,"type":76},"2024-03-15","ACTUAL",{"date":78,"type":60},"2024-05-01",{"date":80,"type":60},"2028-12-31",{"name":46,"class":6}]