[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatocellular-carcinoma-resectable\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatocellular-carcinoma-resectable":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,69,95],{"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":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100594031","phase-2-neoadjuvant-therapy-of-iparomlimab-and-tuvonralimab-combined-with-lenvatinib-for-hepatocellular-carcinoma-100594031",false,"NCT07014150","Neoadjuvant Therapy of Iparomlimab and Tuvonralimab Combined With Lenvatinib for Hepatocellular Carcinoma","An Exploratory Study on the Neoadjuvant Therapy of iIparomlimab and Tuvonralimab Combined With Lenvatinib for Hepatocellular Carcinoma","Inclusion Criteria:\n\n* The subjects voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated with the follow-up\n* Be at least 18 years old at the time of signing the informed consent form, with no gender restrictions.\n* Hepatocellular carcinoma diagnosed by histology or imaging\n* At least one measurable lesion (according to the requirements of RECIST version 1.1, the long diameter of the measurable lesion on spiral CT scan is ≥10mm or the short diameter of the enlarged lymph node is ≥15mm)\n* No systematic treatment has been received before\n* CNLC：Ib to IIIa\n* There is at least one of the following high-risk factors for postoperative recurrence: AFP\\>400ng\u002Fml; Single tumor \\>5cm; The number of tumors is greater than 3 or any one of them is greater than 3cm; There are vascular tumor thrombus or tumors adjacent to large blood vessels, etc.\n* The ECOG score was 0-1 within one week before enrollment\n* Hematology and organ functions are adequate\n* Fertile women: Agree to abstain from sex (avoid heterosexual intercourse) or use contraceptive methods with an annual contraceptive failure rate of less than 1% during the treatment period and for at least 6 months after the last administration\n\nExclusion Criteria:\n\n* Have received any systemic treatment\n* ECOG score \\>1\n* Definite extrahepatic metastasis\n* Pregnant women (with a positive pregnancy test before taking the medicine) or lactating women\n* Those who are known to be allergic or intolerant to recombinant humanized PD-1 monoclonal antibody drugs and their components (or any excipients)\n* Previous or existing grade 3 or above digestive tract fistulas or non-digestive tract fistulas (such as skin) as defined by CTCAE 5.0 criteria\n* Major surgical operations (except biopsy) have been performed within 4 weeks before the first study of drug treatment or the surgical incision has not fully healed\n* Cardiovascular and cerebrovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction and severe\u002Funstable angina pectoris that occurred within 6 months before enrollment\n* Insufficiency of liver and kidney functions, such as jaundice, ascites, and\u002For bilirubin \\>3×ULN, creatinine ratio \\>3.5g\u002F24 hours, etc\n* Persistent infection of grade \\>2 (CTCAE 5.0)\n* A history of thromboembolism (including stroke and\u002For transient ischemic attack) within the past 6 months\n* Hypertension that has not been well controlled after antihypertensive drug treatment (systolic blood pressure \\>160mmHg, diastolic blood pressure \\>100mmHg)\n* An active autoimmune disease or a history of autoimmune diseases in the past two years\n* Active central nervous system (CNS) metastases and\u002For cancerous meningitis\n* Be ready or have received organ or allogeneic bone marrow transplants before\n* Known history of active tuberculosis (Mycobacterium tuberculosis)\n* A history of gastrointestinal bleeding within the past 6 months or a clear tendency towards gastrointestinal bleeding\n* History of human immunodeficiency virus (HIV) infection\n* Positive for active hepatitis B or hepatitis C and has not received regular treatment. During the screening period, HBV DNA≥2000 IU\u002Fml (or ≥104 copy number \u002Fml), entecavir must be used to reduce it to \\\u003C2000 IU\u002Fml (or \\\u003C 104 copy number \u002Fml) before enrollment\n* There is drug abuse; Or any medical, psychological or social conditions that may affect the research, cause unstable patient compliance, or even endanger patient safety\n* Unresolved toxicity of grade \\> 1 due to any previous treatment\u002Fprocedure (CTCAE 5.0, excluding alopecia, anemia, and hypothyroidism).\n* Patients with objective evidence of severe lung function impairment in the past or at present, such as a history of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, and drug-related pneumonia\n* Received treatment with potent CYP3A4 inhibitors within 7 days before participating in the study\n* Accompanied by other malignant tumors, but having had other untreated malignant tumors in the past (within 5 years) or simultaneously, for cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix, treated superficial bladder cancer and prostate adenocarcinoma that has undergone surgical treatment and whose PSA tumor markers are within the normal range.\n* After a comprehensive assessment of the patient's condition by the researchers, it was determined that they were not suitable to participate in this research\n* Participate in another clinical study","ALL","18 Years","75 Years",{"count":20,"type":21},33,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to learn if the neoadjuvant therapy of iIparomlimab and Tuvonralimab plus lenvatinib works to treat hepatocellular carcinoma(HCC) patients with high risk of recurrence. It will also learn about the safety of the combination of iIparomlimab and Tuvonralimab plus lenvatinib. The main questions it aims to answer are:\n\nDoes the combination therapy improve the major pathological response rate and reduce the risk of disease recurrence or progression in HCC patients? What medical problems do participants have when taking this combination regimen? Researchers will compare this combination to previous studies to evaluate its efficacy and safety in managing HCC.\n\nParticipants will:\n\nTake iIparomlimab and Tuvonralimab every 3 weeks for three times and lenvatinib everyday for 9 weeks.\n\nVisit the clinic once every 3 weeks for checkups and tests Keep a diary of their symptoms and the number of times when taking the combination regimen.",[27],"Hepatocellular Carcinoma Resectable",[29,30,31,32,33],"iIparomlimab and Tuvonralimab","lenvatinib","neoadjuvant therapy","high-risk recurrence","hepatocellular carcinoma","RECRUITING","2026-04-29",{"date":37,"type":38},"2026-05-05","ACTUAL",{"date":40,"type":38},"2025-06-10",{"date":42,"type":21},"2027-05-31",{"name":44,"class":45},"Peking Union Medical College Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100528153","prediction-of-hepatocellular-carcinoma-recurrence-after-curative-treatment-by-longitudinal-monitoring-mrd-based-on-ctdna-100528153","NCT06157060","Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring MRD Based on ctDNA","Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring Minimal Residual Disease Based on Circulating Tumor DNA","Inclusion Criteria:\n\n1. Male or female patients aged 18-75 years;\n2. Preoperative imaging examination diagnosed hepatocellular carcinoma (BCLC) stage 0 \u002F stage A\u002Fstage B, eligible for radical surgery;\n3. ECOG physical status score is 0-1;\n4. Child-Pugh score is 5-6 points (Level A);\n5. Not received any anti-tumor therapy;\n6. Laboratory tests were at normal levels within 7 days before enrollment.\n\nExclusion Criteria:\n\n1. Patient can't provide blood samples for ctDNA testing;\n2. Patient with two or more types of tumors at the same time;\n3. Non-primary liver lesions;\n4. Pregnant or lactating women;\n5. Patient with a history of other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma;\n6. Patient with serious heart disease;\n7. Other conditions deemed unsuitable for inclusion by the researcher.",{"count":55,"type":21},255,"OBSERVATIONAL","This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.",[27],"2026-03-18",{"date":61,"type":38},"2026-03-20",{"date":63,"type":38},"2023-11-20",{"date":65,"type":21},"2028-11-30",{"name":67,"class":45},"Zhujiang Hospital",7,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":93,"locationsCount":46},"100620879","phase-2-drug-sensitivity-testing-based-tumor-organoids-to-guide-adjuvant-therapy-after-hepatectomy-for-primary-liver-cancer-100620879","NCT07363356","Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer","Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer: A Prospective, Non-Randomized，Open-Label, Phase II Clinical Trial","Inclusion Criteria:\n\n1. Male or female, aged 18 to 70 years.\n2. Diagnosed with primary liver cancer according to the diagnostic criteria of the primary liver cancer (e.g., Guidelines for Diagnosis and Treatment of Primary Liver Cancer), with post-operative pathological confirmation of hepatocellular carcinoma (HCC). Patients must have at least one of the following high-risk pathological features: tumor diameter \\>5 cm, more than 3 tumors, presence of microvascular invasion, presence of minor macrovascular invasion, or poor pathological differentiation (Grade 3\u002F4).\n3. The subject or their legal guardian understands and voluntarily signs the informed consent form, and is willing and able to complete the scheduled visits, treatment plan, and laboratory tests as required by the protocol.\n4. Life expectancy of more than 6 months.\n5. No radiotherapy within 12 weeks prior to the first dose of study drug.\n6. Liver function classified as Child-Pugh Class A or Class B with a score of 7.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Adequate organ and bone marrow function, defined as laboratory values meeting the following criteria within 7 days prior to randomization (without the support of blood transfusions, hematopoietic growth factors, albumin, or other corrective drugs within 14 days prior to obtaining the laboratory tests):\n\n   8.1. Hematological:\n\n   8.1. 2. Absolute Neutrophil Count (ANC) ≥1.5 × 10⁹\u002FL\n\n   8.1. 3. Platelet count (PLT) ≥75 × 10⁹\u002FL\n\n   8.1. 4. Hemoglobin (HGB) ≥9.0 g\u002FdL\n\n   8.2. Hepatic:\n\n   8.2.1. Total Bilirubin (TBIL) ≤3 × Upper Limit of Normal (ULN)\n\n   8.2.2. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline Phosphatase (ALP) ≤5 × ULN\n\n   8.2.3. Serum Albumin ≥28 g\u002FL\n\n   8.3. Renal:\n\n   8.3.1. Serum Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CCr) ≥ 50 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n\n   8.3.2. Urinalysis shows urine protein \\\u003C 2+; if baseline urinalysis shows urine protein ≥ 2+, a 24-hour urine collection must demonstrate 24-hour urine protein quantification \\\u003C1 g.\n\n   8.4. Coagulation:\n\n   8.4.1. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN\n9. For women of childbearing potential (WOCBP), a negative urine or serum pregnancy test must be confirmed within 3 days prior to receiving the first dose of study drug (Cycle 1, Day 1). If the urine pregnancy test is inconclusive, a serum pregnancy test is required. WOCBP and male subjects must agree to use adequate contraception during the observation period and for at least 8 weeks after the last dose of the study drug. A woman is considered not of childbearing potential if she is postmenopausal (≥1 year without menses) or has undergone surgical sterilization (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation). Subjects (both male and female) with risk of pregnancy must use highly effective contraception (with a failure rate of \\\u003C1% per year) during the entire treatment period and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy agents).\n\nExclusion Criteria:\n\n1. Uncorrectable coagulopathy or significant bleeding tendency.\n2. Evidence of any concurrent malignant disease.\n3. Diagnosed with another malignancy within 3 years prior to the first dose, except for radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has undergone curative resection.\n4. Requiring long-term anticoagulant or antiplatelet therapy that cannot be discontinued.\n5. Presence of hepatic encephalopathy or refractory pleural effusion\u002Fascites requiring therapeutic intervention.\n6. Received other anti-tumor or systemic therapies within 2 weeks prior to enrollment, including:\n\n   6.1. Chinese herbal medicines with clear anti-tumor properties.\n\n   6.2. Chinese herbal medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion).\n7. History of systemic treatment for active autoimmune disease or ongoing immunosuppressive therapy:\n\n   7.1. autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement) is not considered a form of systemic treatment.\n\n   7.2. Systemic corticosteroid therapy (excluding topical, nasal, inhaled, or other non-systemic routes) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. The use of physiologic doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) is permitted.\n8. Severe hepatic or renal insufficiency.\n9. Presence of any severe or uncontrolled systemic disease, including but not limited to:\n\n   9.1. Clinically significant, poorly controlled resting ECG abnormalities (e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmias, or atrial fibrillation).\n\n   9.2. Unstable angina, congestive heart failure (New York Heart Association (NYHA) Class ≥ II).\n\n   9.3. Myocardial infarction within 6 months prior to randomization.\n\n   9.4. History of esophageal or gastric variceal bleeding within 6 months prior to enrollment.\n\n   9.5. Poorly controlled hypertension (systolic blood pressure \\>140 mmHg and\u002For diastolic blood pressure \\>90 mmHg).\n\n   9.6. History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year prior to the first dose, or current clinically active interstitial lung disease.\n\n   9.7. Active tuberculosis.\n\n   9.8. Active or uncontrolled infection requiring systemic therapy.\n\n   9.9. Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.\n\n   9.10. Decompensated liver disease, acute or chronic active hepatitis.\n\n   9.11. Unstable or active peptic ulcer disease, or patients with gastrointestinal bleeding.\n\n   9.12. Poorly controlled diabetes mellitus (fasting blood glucose \\>10 mmol\u002FL).\n\n   9.13. Urinalysis showing urine protein ≥ ++ and confirmed 24-hour urine protein \\>1.0 g.\n\n   9.14. Uncontrolled hypercalcemia (\\>1.5 mmol\u002FL ionized calcium, or calcium \\>12 mg\u002FdL, or corrected serum calcium \\> ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy.\n\n   9.15. Non-healing wound(s) or fracture(s).\n\n   9.16. Psychiatric disorder that compromises the ability to comply with the treatment protocol.\n10. Female subjects who are breastfeeding or pregnant.\n11. Assessed by the investigator as being unable or unwilling to comply with the requirements of the study protocol.\n12. Known allergy to any of the study drug(s) used in this trial.","70 Years",{"count":78,"type":21},56,[24],"This is a single-center, prospective, non-randomized, open-label, phase II clinical trial aiming to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (ODST) to guide personalized adjuvant therapy in patients with primary liver cancer (HCC) following curative liver resection. A total of 56 eligible patients will be enrolled. Tumor tissues obtained during surgery will be used to establish organoid cultures. Drug sensitivity testing will be performed on a panel of approved targeted and immunotherapeutic agents (including Apatinib, Atezolizumab + Bevacizumab, Donafenib + Toripalimab, Sintilimab, and FOLFOX) to identify the most effective treatment for each patient. Patients for whom organoid testing fails or results are unavailable within the specified timeframe will receive standard Lenvatinib treatment. The primary endpoint is Recurrence-Free Survival (RFS). Secondary endpoints include Overall Survival (OS) and safety profiles. The study seeks to provide a novel strategy for personalized adjuvant therapy in HCC to improve patient outcomes.",[27],[83,84,85],"organoid;","drug-sensitive test;","adjuvant therapy","NOT_YET_RECRUITING","2026-01-22",{"date":89,"type":38},"2026-01-23",{"date":91,"type":21},"2026-01-30",{"date":65,"type":21},{"name":94,"class":45},"Eastern Hepatobiliary Surgery Hospital",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":102,"targetDuration":104,"studyType":56,"phases":4,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":5},"100550651","compare-the-accuracy-of-ctdna-mrd-and-mvi-result-in-predicting-postoperative-recurrence-of-hepatocellular-carcinoma-100550651","NCT06449846","Compare the Accuracy of ctDNA-MRD and MVI Result in Predicting Postoperative Recurrence of Hepatocellular Carcinoma","Compare the Accuracy of Circulating Tumor DNA Longitudinal Monitoring Minimal Residual Disease and Microvascular Invasion Result in Predicting Postoperative Recurrence of Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Male or female patients aged 18-75 years;\n2. Preoperative imaging examination diagnosed hepatocellular carcinoma (BCLC) stage 0\u002F stage A\u002Fstage B, eligible for radical surgery;\n3. ECOG physical status score is 0-1;\n4. Child-Pugh score is 5-6 points (Level A);\n5. Not received any anti-tumor therapy;\n6. Laboratory tests were at normal levels within 7 days before enrollment.\n\nExclusion Criteria:\n\n1. Patient can't provide blood samples for ctDNA testing;\n2. Patient with two or more types of tumors at the same time;\n3. Non-primary liver lesions;\n4. Pregnant or lactating women;\n5. Patient with a history of other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma;\n6. Patient with serious heart disease;\n7. Other conditions deemed unsuitable for inclusion by the researcher.",{"count":103,"type":21},152,"2 Years","The aim of this study was to compare the accuracy of ctDNA-MRD longitudinal surveillance model and internationally accepted pathological MVI results in predicting recurrence after radical hepatectomy. At the same time, to explore the relationship among the two methods of predicting recurrence of hepatocellular carcinoma, postoperative adjuvant therapy and postoperative recurrence, this study further confirmed the effectiveness of ctDNA-MRD longitudinal monitoring model in monitoring postoperative recurrence of hepatocellular carcinoma and guiding treatment.",[27,107,108],"Surgery","Recurrence",[110,111,112,113],"Hepatocellular Carcinoma","Circulating Tumor DNA","Minimal Residual Disease","Microvascular Invasion","2024-06-03",{"date":116,"type":38},"2024-06-10",{"date":118,"type":21},"2024-06-01",{"date":120,"type":21},"2026-12-31",{"name":67,"class":45}]