[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xuhua Duan\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":112},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,63,83],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100606815","the-treatment-of-unresectable-liver-cancer-with-e-tace-combined-with-donafeniba-prospective-single-arm-multicenter-observational-study-100606815",false,"NCT07180459","The Treatment of Unresectable Liver Cancer With E-TACE Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study","The Treatment of Unresectable Liver Cancer With Graded Embolization of Uniform-sized Drug-loaded Microspheres Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study","Inclusion Criteria:\n\n* (1) Patients with unresectable primary liver cancer who strictly meet the clinical diagnostic criteria of the \"Primary Liver Cancer Diagnosis and Treatment Guidelines\" (2024 Edition) or who have been diagnosed through pathological histology or cytology examination, and who have at least one measurable lesion (according to the mRECIST 1.1 version, the long diameter of the measurable lesion on spiral CT scan should be ≥ 10mm or the short diameter of the enlarged lymph node should be ≥ 15mm); (2) Tumor staging: CNLC stage Ib, IIa, IIb, IIIa, IIIb or BCLC A, B, C stage; non-diffuse liver cancer (PVTT classified according to the Japanese Liver Cancer Research Society's portal vein tumor thrombus characteristics as Vp1\u002F2, Vp3, Vp4); (3) Gender of the patients is not restricted, and the age is 18-80 years old; expected lifespan is ≥ 3 months; (4) Within 1 week before enrollment, the ECOG PS score: 0-1; (5) No severe comorbidities, such as hypertension, coronary heart disease and history of mental illness, no severe allergy history; (6) Liver function should reach Child-Pugh grade A or B; (7) Laboratory tests meet the following requirements: platelets ≥ 50×109\u002FL; hemoglobin ≥ 9g\u002FdL; white blood cells ≥ 4×109\u002FL; neutrophils ≥ 1.5×109\u002FL); serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN), transaminases (ALT, AST) ≤ 5 times ULN; creatinine ≤ 1.5 times ULN; urine routine shows urine protein \\\u003C 2+; for patients whose urine protein ≥ 2+ at baseline, 24-hour urine collection should be conducted and the 24-hour urine protein quantification \\\u003C 1g; international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; (8) HBV DNA \\\u003C 2000 IU\u002Fml (104 copies\u002Fml); (9) For pregnant women of childbearing age, a pregnancy test should be conducted within 7 days before enrollment; (10) Patients have signed the informed consent form agreeing to participate in this trial study; good compliance and cooperation with treatment.\n\nExclusion Criteria:\n\n* (1) Imaging examination shows that the liver tumor is huge (≥ 60% of liver volume), or there is a main portal vein tumor thrombus (occupying the vascular diameter ≥ 50%), or the tumor thrombus invades the mesenteric vein or inferior vena cava, or there are obvious native hepatic artery - portal vein fistulas and native hepatic artery - hepatic vein fistulas that cannot safely use drug-loaded microspheres; (2) Before participating in this study, they have undergone local treatments such as traditional TACE, thermal ablation, cryoablation, external radiotherapy and radioactive particle implantation, and have received systemic chemotherapy, oral liver cancer targeted drugs (sorafenib, lenafolate, apatinib) and immune therapy (PD-1\u002FPD-L1\u002FCDLA-4\u002Fbiologic double therapy); (3) Patients with diffuse liver cancer; known hepatocellular carcinoma and mixed cell carcinoma and fibroplastic cell carcinoma; having other untreated malignant tumors in the past (within 5 years) or simultaneously; except for cured skin basal cell carcinoma and cervical carcinoma in situ; (4) Having grade II or above myocardial ischemia or myocardial infarction, and uncontrolled arrhythmia (including QTc interval for males ≥ 450ms, females ≥ 470ms); (5) Having a history of gastrointestinal bleeding in the past 6 months or having a clear tendency for gastrointestinal bleeding, such as: esophageal varices with bleeding risk, local active ulcer lesion, fecal occult blood ≥ (++), not eligible for inclusion; if fecal occult blood (+), a gastroscopy examination is required; (6) Abnormal coagulation function (INR \\> 1.5 or prothrombin time (PT) \\> ULN + 4 seconds), bleeding tendency or undergoing thrombolysis or anticoagulation treatment; (7) Patients with central nervous system metastasis or known brain metastasis; having objective evidence of past and current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of pulmonary function; patients with combined HIV infection; pregnant or lactating patients; patients preparing for liver transplantation (except for patients who have undergone liver transplantation in the past); (8) Severe systemic failure, with an expected survival period \\\u003C 3 months; (9) Severe renal dysfunction (creatinine \\> 2mg\u002Fdl or creatinine clearance rate \\\u003C 30ml\u002Fmin); (10) Unable to complete the treatment plan due to various reasons, and lost follow-up within three months after enrollment.","ALL","18 Years","80 Years",{"count":20,"type":21},118,"ESTIMATED","1 Year","OBSERVATIONAL","To clarify the safety and efficacy of using uniform-sized drug-loaded embolic microspheres (E-TACE) of different particle sizes for graded embolization during TACE combined with Donafenib in the treatment of unresectable primary liver cancer. To determine whether this therapy can prolong the ORR, DCR, PFS, OS and other indicators.",[26,27],"Carcinoma","Hepatocellular Carcinoma","NOT_YET_RECRUITING","2025-09-12",{"date":31,"type":32},"2025-09-18","ACTUAL",{"date":34,"type":21},"2025-10-10",{"date":36,"type":21},"2027-10-10",{"name":38,"class":39},"Xuhua Duan","OTHER",10,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100604984","a-study-on-the-heterogeneity-of-efficacy-of-interventional-therapy-combined-with-systemic-therapy-for-liver-cancer-based-on-multi-center-real-world-data-100604984","NCT07156617","A Study on the Heterogeneity of Efficacy of Interventional Therapy Combined With Systemic Therapy for Liver Cancer Based on Multi-center Real-world Data","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years old, gender not restricted; 2. Diagnosed with HCC through pathological or imaging examination, and meeting the diagnostic criteria of the \"Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)\"; 3. Has received or plans to receive interventional therapy combined with systemic treatment (including but not limited to DEB-TACE combined with targeted therapy, DEB-TACE combined with targeted therapy and immunotherapy, DEB-TACE combined with targeted therapy and immunotherapy other local interventional treatments (such as HAIC, ablation, particle implantation, etc.)); 4. Has completed baseline clinical information and treatment records, can cooperate with the follow-up arrangement, and has the willingness and ability to complete the entire research process; 5. Signed the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Diagnosed with liver metastatic cancer or other primary malignant tumors that are not HCC, or with concurrent other active primary malignant tumors; 2. Clearly have severe cognitive impairment, mental illness or confusion, and are unable to cooperate with the visit or fill out the scale; 3. Expected survival period is less than 3 months or clinical judgment indicates that follow-up cannot be completed; 4. Liver function is in decompensation, with Child-Pugh classification as C; 5. The investigator considers any other situation that is not suitable for participating in this study.",{"count":48,"type":21},2000,"The system assesses the heterogeneity of HCC patients in terms of therapeutic outcomes (such as rwPFS, ORR, PRO) and adverse reactions during the process of interventional therapy combined with systemic treatment. It explores the clinical characteristics and biomarker levels of patients related to heterogeneity and builds a machine learning model to predict the risk of adverse reactions, providing evidence support for the construction of a patient-centered individualized decision-making system.",[51],"Hepatocellular Carcinoma (HCC)",[53],"Hepatocellular carcinoma","2025-08-28",{"date":56,"type":32},"2025-09-05",{"date":58,"type":21},"2025-10-01",{"date":60,"type":21},"2028-10-01",{"name":38,"class":39},14,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100579342","a-prospective-multicenter-phase-ii-clinical-study-on-the-treatment-of-unresectable-advanced-hcc-with-deb-tace-combined-with-salox-haic-100579342","NCT06823050","A Prospective, Multicenter, Phase II Clinical Study on the Treatment of Unresectable Advanced HCC with DEB-TACE Combined with SALOX-HAIC","A Prospective, Multicenter, Phase II Clinical Study on the Treatment of Unresectable Advanced Hepatocellular Carcinoma with the DEB-TACE (drug-loaded Microsphere Transcatheter Arterial Chemoembolization) Combined with Hepatic Artery Perfusion of Raltitrexed and Oxaliplatin (SALOX-HAIC) Regimen","Inclusion Criteria:\n\n* 1\\. Patient with unresectable HCC who strictly meet the clinical diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) or who have been confirmed by histopathology or cytology, There was at least one measurable lesion (according to the requirements of mRECIST 1.1, the spiral CT scan diameter of the measurable lesion was ≥10mm or the short diameter of enlarged lymph node was ≥15mm).\n\n  2\\. CNLC Ib-IIIa；BCLC：A-C 3. Patient age between 18 and 80，male or female. 4. ECOG 0-1. 5.Expected life span ≥ 3 months. 6. No history of severe comorbidities, such as hypertension, coronary heart disease, and mental illness, and no history of severe allergies.\n\n  7\\. Child-Pugh A-B. 8.The laboratory tests meet the following requirements: platelets ≥ 50×109\u002FL; hemoglobin ≥ 9g\u002FdL; white blood cells ≥ 4×109\u002FL; neutrophils ≥ 1.5×109\u002FL; serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN), transaminases (ALT, AST) ≤ 5 times ULN; creatinine ≤ 1.5 times ULN; urine routine test shows that urine protein \\\u003C 2+; for patients whose urine routine test at baseline showed urine protein ≥ 2+, 24-hour urine collection should be conducted and the 24-hour urine protein quantification should be \\\u003C 1g; international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.\n\n  9\\. HBV DNA\\\u003C2000 IU\u002Fml. 10. Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment.\n\n  11\\. Patients sign informed consent, good compliance, cooperate with treatment.\n\nExclusion Criteria:\n\n* 1\\. Imaging examinations were conducted for HCC patients with large liver tumors (≥60% of liver volume), or carcinoma thrombus in main portal vein (occupying ≥50% of vascular diameter), or carcinoma thrombus invading mesenteric vein or inferior vena cava, or significant arteriovenous\u002Fvenous fistula.\n\n  2\\. Before participating in this study, she had received local treatment such as TACE, external radiotherapy and radioactive particle implantation, and had undergone systemic chemotherapy, oral liver cancer targeting drugs (Sorafenib, Lenfacitinib, Apatinib) and immunotherapy such as PD-1\u002FPD-L1\u002FCDLA-4.\n\n  3\\. Diffuse liver cancer patients. 4. Patients with grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms for men and 470ms for women.\n\n  5\\. A history of gastrointestinal bleeding within the past 6 months or a definite tendency to gastrointestinal bleeding.\n\n  6\\. Abnormal clotting function, bleeding tendency or receiving thrombolytic or anticoagulant therapy.\n\n  7\\. Patients with central nervous system metastases or known brain metastases. Co-infected patients with HIV; Pregnant or lactating patients. Patients preparing for liver transplantation (other than those with previous liver transplantation.\n\n  8\\. Systemic failure, estimated survival time \\\u003C3 months. 9. Severe renal dysfunction. 10. The patients could not complete the treatment plan due to various reasons, and lost control within three months after enrollment.",{"count":71,"type":21},59,"The aim of this study is to clarify the safety and efficacy of DEB-TACE combined with SALOX-HAIC in the treatment of unresectable advanced primary liver cancer. To determine whether this therapy can prolong the indicators such as PFS, TTP, OS, ORR, and DOR.",[27],"2025-02-07",{"date":76,"type":32},"2025-02-12",{"date":78,"type":21},"2025-03-01",{"date":80,"type":21},"2028-02-28",{"name":38,"class":39},7,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100499867","deb-tace-versus-deb-tace-sequential-haic-for-unresectable-bclc-stage-c-hcc-a-randomized-controlled-trial-100499867","NCT05788835","DEB-TACE Versus DEB-TACE Sequential HAIC for Unresectable BCLC Stage C HCC; A Randomized Controlled Trial","Drug-eluting Bead Transarterial Chemoembolization and Drug-eluting Bead Transarterial Chemoembolization Sequential Hepatic Artery Chemotherapy Infusion for Unresectable BCLC Stage C HCC: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patient with unresectable HCC who strictly meet the clinical diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) or who have been confirmed by histopathology or cytology, There was at least one measurable lesion (according to the requirements of mRECIST 1.1, the spiral CT scan diameter of the measurable lesion was ≥10mm or the short diameter of enlarged lymph node was ≥15mm).\n2. The sum of the diameter of single or 2-3 tumors ≥5cm. Tumor stage: Stage C of BCLC.\n3. Patient age between 18 and 75，male or female.\n4. ECOG 0-1.\n5. Expected life span ≥ 3 months.\n6. No history of severe comorbidities, such as hypertension, coronary heart disease, and mental illness, and no history of severe allergies.\n7. Child-Pugh A-B.\n8. HBV DNA\\\u003C2000 IU\u002Fml.\n9. Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment.\n10. Patients sign informed consent, good compliance, cooperate with treatment.\n\nExclusion Criteria:\n\n1. Imaging examinations were conducted for HCC patients with large liver tumors (≥60% of liver volume), or carcinoma thrombus in main portal vein (occupying ≥50% of vascular diameter), or carcinoma thrombus invading mesenteric vein or inferior vena cava, or significant arteriovenous\u002Fvenous fistula.\n2. Before participating in this study, she had received local treatment such as TACE, external radiotherapy and radioactive particle implantation, and had undergone systemic chemotherapy, oral liver cancer targeting drugs (Sorafenib, Lenfacitinib, Apatinib) and immunotherapy such as PD-1\u002FPD-L1\u002FCDLA-4.\n3. Diffuse liver cancer patients.\n4. Patients with grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms for men and 470ms for women.\n5. A history of gastrointestinal bleeding within the past 6 months or a definite tendency to gastrointestinal bleeding.\n6. Abnormal clotting function, bleeding tendency or receiving thrombolytic or anticoagulant therapy.\n7. Patients with central nervous system metastases or known brain metastases. Co-infected patients with HIV; Pregnant or lactating patients. Patients preparing for liver transplantation (other than those with previous liver transplantation.\n8. Systemic failure, estimated survival time \\\u003C3 months.\n9. Severe renal dysfunction.\n10. The patients could not complete the treatment plan due to various reasons, and lost control within three months after enrollment.","75 Years",{"count":92,"type":21},220,"INTERVENTIONAL",[95],"NA","This is a randomized controlled trial to determine the efficacy and safety of DEB-TACE versus DEB-TACE sequential HAIC for unresectable BCLC stage C HCC",[98],"HCC",[100,101],"DEB-TACE- HAIC","DEB-TACE","RECRUITING","2023-03-28",{"date":105,"type":32},"2023-03-29",{"date":107,"type":32},"2023-03-07",{"date":109,"type":21},"2026-06-30",{"name":38,"class":39},16,""]