[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"resectable-hepatocellular-carcinoma-with-high-risk-of-recurrence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:resectable-hepatocellular-carcinoma-with-high-risk-of-recurrence":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100589415","phase-2-iparomlimab-and-tuvonralimab-as-neoadjuvant-therapy-for-resectable-hepatocellular-carcinoma-with-high-risk-of-recurrence-100589415",false,"NCT06954116","Iparomlimab and Tuvonralimab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With High Risk of Recurrence","A Prospective, Open-Label, Single-Arm, Exploratory Clinical Study on the Anti-Recurrence Effect of Neoadjuvant Iparomlimab and Tuvonralimab in Resectable Hepatocellular Carcinoma With High Risk of Recurrence After Radical Resection","CCGLC-017","Inclusion Criteria:\n\n* Hepatocellular carcinoma is proven on biopsy or confirmed by the presence of radiological hallmarks, according to the American Association for the Study of Liver Diseases or European Association for the Study of the Liver guidelines.\n* Aged 18 to 75 years.\n* BCLC A\u002FB, or BCLC C without extrahepatic metastasis.\n* Suitable for radical surgery after evaluation by the hepatobiliary tumor MDT expert group.\n* No distant metastasis confirmed by CT or MRI.\n* No prior systemic anti-tumor treatment for hepatocellular carcinoma before the first dose.\n* ECOG ≤ 2.\n* Child-Pugh ≤ 7.\n* Adequate organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to inclusion (no blood components, cell growth factors, albumin, or other intravenous or subcutaneous corrective treatment drugs are allowed within 14 days prior to obtaining laboratory tests):\n\n  1. Complete blood count: Absolute Neutrophil Count (ANC) ≥1.5×10\\^9\u002FL; Platelet count (PLT) ≥75×10\\^9\u002FL; Hemoglobin (HGB) ≥9.0 g\u002FdL.\n  2. Liver function: Total Bilirubin (TBIL) ≤2×Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤5×ULN; Serum albumin ≥28 g\u002FL; Alkaline Phosphatase (ALP) ≤5×ULN.\n\nC. Kidney function: Serum Creatinine (Cr) ≤ 1.5×ULN or Clearance of Creatinine (CCr) ≥50mL\u002Fmin (Cockcroft-Gault formula); Urinalysis shows proteinuria \\\u003C2+; For subjects with baseline urinalysis showing proteinuria ≥2+, a 24-hour urine collection should be performed and 24-hour urinary protein quantification \\\u003C1g.\n\nD. Coagulation function: International Normalized Ratio (INR) ≤2.3 or Prothrombin Time (PT) extension ≤6 seconds.\n\n* Meet the criteria for resectable HCC with High Risk of Recurrence:\n\n  1. Multiple (≥2) tumors.\n  2. Segmental portal vein invasion (Vp1\u002FVp2).\n  3. CT\u002FMRI imaging: gross classification: type II, III, IV.\n* Estimated life expectancy of ≥12 weeks.\n* Female subjects of childbearing age or male subjects whose sexual partners are of childbearing age need to take effective contraceptive measures during the entire treatment period and for 6 months after the last medication.\n* Signed written informed consent, and able to comply with the visit and related procedures stipulated in the protocol.\n\nExclusion Criteria:\n\n* Histologically\u002Fcytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.\n* History of hepatic encephalopathy or liver transplantation.\n* Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage. Subjects with only radiologically detected minimal pleural effusion, ascites, or pericardial effusion without symptoms can be enrolled.\n* Acute or chronic active hepatitis B or C infection, with hepatitis B virus (HBV) DNA \\>2000IU\u002Fml or 10\\^4 copies\u002Fml; hepatitis C virus (HCV) RNA \\>10\\^3 copies\u002Fml; co-positive for hepatitis B surface antigen (HbsAg) and anti-HCV antibody. Subjects who meet the above criteria after antiviral treatment with nucleoside analogs can be enrolled.\n* History of esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months. Subjects assessed by the investigator to be at high risk of bleeding.\n* Any life-threatening bleeding event within the past 3 months, including those requiring blood transfusion, surgery or local treatment, or continuous drug treatment.\n* History or current diagnosis of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function, and other lung diseases.\n* Active pulmonary tuberculosis, currently receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year prior to the first dose.\n* Active autoimmune disease requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is allowed. History of primary immunodeficiency. Patients with only autoantibody positivity need to be confirmed by the investigator whether there is an autoimmune disease.\n* History of arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other serious thromboembolic events. Exceptions are made for thrombosis formation related to implanted venous infusion ports or catheters, or superficial vein thrombosis that has stabilized after routine anticoagulation treatment. Preventive use of low-dose low molecular weight heparin (such as enoxaparin 40 mg\u002Fday) is allowed.\n* Continuous use of aspirin (\\>325 mg\u002Fday) or other known platelet function inhibitors such as clopidogrel or ticlopidine for 10 days within 2 weeks prior to the first dose.\n* Uncontrolled hypertension, with systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy.\n* Major surgery (craniotomy, thoracotomy, or laparotomy) or unhealed wound, ulcer, or fracture within 4 weeks prior to the first dose. Minor surgical procedures or tissue biopsy within 7 days prior to the first dose, excluding venous puncture for the purpose of intravenous infusion, are excluded.\n* Uncontrolled\u002Funcorrectable metabolic disorders or other non-malignant organ diseases or systemic diseases or secondary reactions to cancer, which can lead to higher medical risk and\u002For uncertainty in survival evaluation, or other conditions judged by the investigator to be unsuitable for enrollment.\n* History of gastrointestinal perforation and\u002For fistula within the previous 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea.","ALL","18 Years","75 Years",{"count":21,"type":22},26,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The purpose of this study is to evaluate the impact of iparomlimab and tuvonralimab as preoperative neoadjuvant therapy on recurrence-free survival (RFS), along with its potential improvement in overall survival (OS), in patients with resectable hepatocellular carcinoma (HCC) at high risk of recurrence.",[28],"Resectable Hepatocellular Carcinoma With High Risk of Recurrence",[30,31,32,33,34],"Hepatocellular Carcinoma","Neoadjuvant Therapy","Iparomlimab and Tuvonralimab","Immunotherapy","Anti-recurrence","RECRUITING","2026-09-17",{"date":38,"type":39},"2026-09-18","ACTUAL",{"date":41,"type":39},"2025-08-01",{"date":43,"type":22},"2029-04-01",{"name":45,"class":46},"Tongji Hospital","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100611335","phase-2-study-to-evaluate-the-efficacy-and-safety-of-neo-adjuvant-tace-and-atezolizumab-plus-bevacizumab-therapy-for-high-risk-recurrent-hepatocellular-carcinamo-100611335","NCT07239245","Study to Evaluate the Efficacy and Safety of Neo-Adjuvant TACE and Atezolizumab Plus Bevacizumab Therapy for High-Risk Recurrent Hepatocellular Carcinamo","Efficacy and Safety of Transarterial Chemoembolization (TACE) Combined With Atezolizumab Plus Bevacizumab in Neoadjuvant Therapy for Patients With Hepatocellular Carcinoma: an Open-label, Single-arm, Multicenter, Prospective, Phase II Clinical Study","ATTACH","Inclusion Criteria:\n\n1. Signed Informed Consent Form available\n2. Patients ≥ 18 years and ≤75years of age at time of signing Informed Consent Form\n3. Diagnosis of HCC confirmed by histology\n4. Initially resectable with high-risk recurrence factors. High-risk features for resected patients include tumor size \\>5 cm, tumor number \\>3, vascular invasion (microvascular invasion or macrovascular invasion - Vp1\u002FVp2 - of the portal vein) and poor tumor differentiation (defined as Grade 3 or 4).\n\n   Up to three tumors, with largest tumor \\>5 cm regardless of vascular invasion (microvascular invasion or macrovascular invasion of Vp1\u002FVp2) or poor tumor differentiation (Grade 3 or 4) Four or more tumors, with largest tumor ≤5 cm regardless of vascular invasion (microvascular invasion or macrovascular invasion of Vp1\u002FVp2) or poor tumor differentiation (Grade 3 or 4) Up to three tumors, with largest tumor ≤5 cm with vascular invasion (microvascular invasion or macrovascular invasion of Vp1\u002FVp2) and\u002For poor tumor differentiation (Grade 3 or 4)\n5. Measurable disease (at least one target lesion) according to RECIST v1.1 as determined by the investigator\n6. Child-Pugh A\n7. ECOG PS 0～1\n8. No prior locoregional or systemic treatment for HCC\n9. Negative HIV test at screening\n\nExclusion Criteria:\n\n1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma, recurrent HCC and diffuse HCC\n2. Clinically diagnosed hepatic encephalopathy in the last 6 months\n3. Autoimmune hepatitis (requiring liver puncture)\n4. History of organ transplantation\n5. Clinical symptoms of pleural effusion, ascites, pericardial effusion, and any history of kidney disease or nephrotic syndrome\n6. Treatment with investigational therapy within 28 days prior to initiation of study treatment\n7. Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or that are at high risk for bleeding\n8. A prior bleeding event due to esophageal and\u002For gastric varices within 6 months prior to initiation of study treatment\n9. Known severe allergic reaction to contrast (e.g., anaphylaxis).\n10. Pregnancy or lactating women.\n11. Inability to provide informed consent.",{"count":57,"type":22},30,[25],"This is an open-label, single-arm, multicenter, prospective, phase II clinical study to evaluate the efficacy and safety of TACE combined with Atezolizumab and Bevacizumab as neoadjuvant treatment in Hepatocellular Carcinoma.",[28],[30,62,63,64],"Neoadjuvant therapy","TACE","Atezolizumab","2025-11-24",{"date":67,"type":39},"2025-11-25",{"date":69,"type":39},"2025-11-12",{"date":71,"type":22},"2030-11-10",{"name":73,"class":46},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",4,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":83,"targetDuration":85,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":96,"leadSponsor":98,"locationsCount":47},"100597914","the-real-world-study-of-ak104-combining-with-tace-for-resectable-hepatocellular-carcinoma-morning-100597914","NCT07064681","The Real-world Study of AK104 Combining With TACE for Resectable Hepatocellular Carcinoma (MORNING)","The Real-World Study of Neoadjuvant Immune-Checkpoint Blockade Therapy Combining With TACE For Resectable Hepatocellular Carcinoma With High Recurrence Risk","MORNING-RWS","Inclusion Criteria:\n\n1. Age ≥18 years but ≤75 years\n2. Resectable HCC staged BCLC A\u002FB\n3. Treatment naïve for HCC\n4. High risk for recurrence, meeting at least one of the following criteria:\n\n   1. Multiple tumor lesions\n   2. Individual tumor \\> 5cm\n   3. AFP \\> 400 ug\u002FL\n   4. MVI positive based on preoperative MRI according to MVI predictive model of Radiomics\n5. Measurable or evaluable lesions according to RECIST v1.1 criteria\n6. ECOG performance status 0-1\n7. Child-Pugh class A\n8. Life expectancy ≥ 12 weeks\n9. Adequate organ and marrow function as defined below:\n\n   1. Hemoglobin ≥9.0 g\u002FdL\n   2. Absolute neutrophil count ≥ 1,500\u002FμL\n   3. Platelets count ≥ 75,000\u002FμL\n   4. Total serum bilirubin ≤ 1.5 ×upper limit of normal(ULN)\n   5. AST and ALT ≤ 5 × ULN, ALP ≤ 4 ×ULN\n   6. Serum creatinine ≤ 1.5 ×ULN\n   7. INR ≤ 1.5 ×ULN, APTT ≤ 1.5 ×ULN\n   8. Serum albumin ≥3.0 g\u002FdL\n10. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test.\n11. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen as assessed by the treating investigator are eligible for this trial.\n12. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Any prior treatment for HCC.\n2. Tumor rupture or bleeding. Suspected abdominal metastasis.\n3. A major surgical procedure, open biopsy, or significant traumatic injury with poorly healed wound within 6 weeks prior to enrollment.\n4. History of allogenic organ transplantation.\n5. Under other clinical trials.\n6. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion: vitiligo or alopecia, hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement, any chronic skin condition that does not require systemic therapy or celiac disease controlled by diet alone.\n7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to AK104 or other immune checkpoint inhibitors.\n8. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection (including tuberculosis), uncontrolled hypertension (defined as blood pressure of \\> 140\u002F90 mmHg during the screening period despite medical management), interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.\n9. History of hepatic encephalopathy, refractory ascites or esophagogastric varices with high risk of bleeding. Upper gastrointestinal hemorrhage within the year prior to the first dose of study drug.\n10. Active hepatitis B infection without treatment (positive HBV surface antigen (HBsAg) and HBV DNA ≥ 1000 IU\u002Fml). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Active hepatitis C infection (positive HCV antibody and HCV RNA above the lower limit of detection).\n11. A primary brain tumor (excluding meningiomas and other benign lesions), any brain metastases, leptomeningeal disease, seizure disorders not controlled with standard medical therapy, or history of a stroke within the year prior to the first dose of study drug.\n12. History of active primary immunodeficiency.\n13. History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\n14. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study agent. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection). Systemic corticosteroids at physiologic doses that do not exceed 10 mg\u002Fday of prednisone or its equivalent. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n15. Receipt of live attenuated vaccine within 30 days prior to the first dose of study drug. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study drug and for at least 30 days after the last dose of study agent.\n16. Systemic immunostimulant therapy within 14 days prior to the first dose of study agent.\n17. History of serious systemic disease, including myocardial infarction or unstable angina within the 12 months prior to the first dose of study drug, hypertensive crisis or hypertensive encephalopathy, New York Heart Association (NYHA) grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication, significant vascular disease or symptomatic peripheral vascular disease.\n18. History of coagulopathy, bleeding diathesis, or thrombosis within the 12 months prior to the first dose of study drug.\n19. A serious, non-healing wound, ulcer, or bone fracture.\n20. Pregnancy or lactation.\n21. Total parenteral nutrition.\n22. Exclusion from the study by the judgement of investigators, due to some factors that may lead to the forced termination of the study, including other acute, chronic or psychological disease.",{"count":84,"type":22},100,"2 Years","OBSERVATIONAL","This is an observational study. All patients who meet the inclusion criteria of our previous Phase 2, open-label, single-arm study of neoadjuvant immune-checkpoint blockade therapy (AK104) combining with TACE for resectable hepatocellular carcinoma, but refuse to receive neoadjuvant treatment will be asked again to participate this observational study retrospectively and prospectively. Participants will receive surgery and regular monitoring for 1 year. The purpose is to provide real-world cohort for comparison with the neoadjuvant cohort.",[28],[90,91],"Resectable Hepatocellular Carcinoma with High Risk of Recurrence","Real-world study","2025-07-05",{"date":94,"type":39},"2025-07-15",{"date":92,"type":22},{"date":97,"type":22},"2026-12-17",{"name":99,"class":46},"Sun Yat-sen University"]