[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatocarcinoma":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,55,83,103,128,152,189,212,243],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100590778","evaluation-of-skin-tests-in-biotherapy-allergies-100590778",false,"NCT06971848","Evaluation of Skin Tests in Biotherapy Allergies","ETCABIO","Inclusion Criteria :\n\n* Patient treated with one of the biotherapies under study (Atezolizumab 1200 mg, Nivolumab 480 mg, Obinutuzumab 100 mg, Durvalumab 1500 mg, Pembrolizumab 200 mg, Daratumumab 1800 mg, Cemiplimab 3500 mg) and who has received at least two injections of the biotherapy without suspected allergic side effects.\n* Subjects covered by or having the rights to medical care assurance\n* Written informed consent obtained from subject\n* If applicable, treatment with corticosteroids and H1 antihistamines by systemic route (IV or oral) which may be discontinued at least one week before performing the tests (Inhaled corticosteroids are allowed).\n\nExclusion Criteria:\n\n* Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests.\n* Poor understanding of the French language\n* Pregnancy, breastfeeding\n* Persons in detention by judicial or administrative decision\n* Person admitted to a health or social establishment for purposes other than research\n* Person subject to a legal protection measure",true,"ALL","18 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. In recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. As such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway.\n\nThese biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. These reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction).\n\nUnlike other treatments, such as antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. We propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck","Melanoma Neoplasms","Small Cell Bronchial Carcinomas","Bronchial Carcinoma","Pleural Mesothelioma","Hodgkin's Lymphoma","Chronic Lymphocytic Leukemia","Follicular Lymphoma","Myeloma","AL Amyloidosis","Hepatocarcinoma","Colorectal Cancer","Esophageal Squamous Cell Carcinoma","Heart Cancer","Cholangiocarcinoma","Colorectal Adenocarcinoma","RECRUITING","2026-06-17",{"date":46,"type":47},"2026-06-18","ACTUAL",{"date":44,"type":47},{"date":50,"type":21},"2028-07",{"name":52,"class":53},"University Hospital, Angers","OTHER_GOV",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":54},"100639604","evaluation-of-tissue-and-circulating-microrna-profiles-in-patients-with-hepatocellular-carcinoma-subjected-to-thermal-ablation-100639604","NCT07601464","Evaluation of Tissue and Circulating microRNA Profiles in Patients With Hepatocellular Carcinoma Subjected to Thermal Ablation","TERMOMIRNA","Inclusion Criteria:\n\n* Age ≥ 18\n* Diagnosis of hepatocarcinoma confirmed by radiology (LIRADS criteria\u002Ftriphasic diagnostics) or by biopsy.\n* Indication for thermoablation treatment (for radiofrequency) based on the judgment of the hepatologist\u002Fsurgeon.\n* Informed consent signed by the patient.\n\nExclusion Criteria:\n\n* Presence of metastatic liver lesions of other origins.\n* History of liver transplant.\n* Severe, uncorrectable coagulopathy, contraindicating liver biopsy (where necessary) or ablative procedure.\n* Patient refusal to participate in the study or inability to obtain informed consent.\n* Pregnant women.","64 Years",{"count":64,"type":21},150,"OBSERVATIONAL","The main objectives of this research project concern the identification of microRNAs circulating and of serum metabolites predictive of treatment response in patients with early stage hepatocellular carcinoma undergoing locoregional treatment with thermoablation.\n\nIn addition, the molecular mechanisms involved in reprogramming will be identified metabolic via bioinformatics analysis and pretreatment liver biopsy analysis and analysis of screening on patient-derived primary lines for personalized therapy.",[37],[69,70,71,72],"hepatocarcinoma","liver cancer","microRNA","thermoablation","2026-05-15",{"date":75,"type":47},"2026-05-22",{"date":77,"type":47},"2026-03-26",{"date":79,"type":21},"2028-12-31",{"name":81,"class":82},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":54},"100626185","decoding-epigenetic-mechanisms-driving-immune-evasion-in-liver-cancer-with-omics-approaches-100626185","NCT07432347","Decoding Epigenetic Mechanisms Driving Immune Evasion in Liver Cancer With Omics Approaches","DELIVER","1. Histological\u002Fradiological (LR-4 o 5)diagnosis of hepatocellular carcinoma (HCC).\n2. Solid tumor fresh tissue availability from HCC biospy or surgical resectionas per standard clinical practice, and\u002ForHCC FFPE archival samples availability.\n3. Capability of understanding and signing an inform consent form.\n4. Known hepatits B and C status, including HBeAg (positive or negative), viral load (HBVDNA e HCV-RNA), HCV genotype, whether sustained virological response (SVR)was obtainedand potential antiviral treatments received (including direct antiretroviral therapy(DAA)and interferon). These parameters will be exploited to stratify patients and analyze the impact of the virological status on microenvironmental immunological features, with particular regards to immunesuppression mechanisms.",{"count":91,"type":21},270,"This is a national, observational, retrospective, cross-sectional, non-profit study focused on patients with HCC. The study aims to characterize the expression and function of novel noncoding regulatory transcripts, including those containing TEsin the microenvironment of liver tumors, with emphasis on their role in T cell dysfunction.",[37],"2026-02-24",{"date":96,"type":47},"2026-02-27",{"date":98,"type":47},"2026-01-01",{"date":100,"type":21},"2031-01-31",{"name":102,"class":82},"Niguarda Hospital",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":113,"studyType":65,"phases":4,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":54},"100556323","prediction-of-decompensation-and-hcc-development-in-advanced-chronic-liver-disease-100556323","NCT06523608","Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease","Prediction of Decompensation and HCC Development in Patients With Advanced Chronic Liver Disease by the PLEASE and M10S20 Algorithms","DETECT","Inclusion Criteria:\n\n* The patient admitted\u002Freferred to study center is hospitalized or is an outpatient with advanced chronic liver disease (based on the BAVENO criteria)\n\nExclusion Criteria:\n\n* Pregnancy\n* Age \\\u003C18\n* Evidence of current malignancy except for non-melanocytic skin cancer\n* Presence or history of severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease (New York Heart Association (NYHA) \\> II); severe chronic pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease (GOLD) \\> III), severe neurological and psychiatric disorders).\n* Human Immunodeficiency Virus (HIV) positive patients.\n* Previous liver or other transplantation.\n* Patients who decline to participate or who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.\n* Physician's denial (e.g. the investigator considers that the patient will not follow the protocol scheduled).",{"count":112,"type":21},600,"2 Years","The aim of this observational study is to predict the short- and long-term development of acute severe disease events, de novo hepatocarcinoma (HCC) and mortality in patients with advanced chronic liver disease using the M10S20 (Liver stiffness and Model for End-Stage Liver Disease Score \\[MELD\\] combined) and PLEASE (Platelet, Etiology, Age, Sex und Elastography) scores, as well as the validation of the cost-effectiveness of the algorithm.\n\nPatients in this study are randomly divided into two groups:\n\n* Control group: patients are examined according to the current clinical standard protocol (biannual follow-up).\n* Stratified surveillance program:\n\n  * High-risk patients will receive an appointment for a hospital visit every 3 months.\n  * Low-risk patients could receive an appointment in one year. When necessary, if decompensation develops or HCC occurs, patients could be followed-up more frequently.",[116,117,37,118],"Liver Diseases","Hepatocellular Carcinoma","Advanced Chronic Liver Disease","2025-12-15",{"date":121,"type":47},"2025-12-22",{"date":123,"type":47},"2024-09-01",{"date":125,"type":21},"2027-09",{"name":127,"class":82},"University Hospital Muenster",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":54},"100585293","phase-2-icariin-soft-capsules-combined-with-tace-as-adjuvant-therapy-for-hcc-100585293","NCT06900478","Icariin Soft Capsules Combined With TACE as Adjuvant Therapy for HCC","Icariin Soft Capsules Combined With TACE as Adjuvant Therapy for Hepatocellular Carcinoma With High-Risk Recurrence Factors:A Single-Center, Prospective Study","Inclusion Criteria:\n\n* Age between 18 and 80 years;\n* ECOG Performance Status (PS) of 0 or 1;\n* Histologically or cytologically diagnosed as HCC\n* Fully recovered from surgical resection or ablation prior to enrollment;\n* Presence of the following high-risk recurrence factors after resection or ablation: tumor maximum diameter \\> 5 cm; multiple tumors; microvascular or major vascular invasion; margin distance from the tumor edge \\\u003C 1 cm; poorly differentiated tumors (Edmondson grade III-IV); lymph node metastasis; persistent abnormal AFP or abnormal prothrombin (DCP);\n* Child-Pugh class A5-B7;\n* Expected survival time \\> 3 months;\n* Normal major organ function: Hemoglobin ≥ 80 g\u002FL, Absolute Neutrophil Count (ANC) ≥ 1.5 × 10\\^9\u002FL, Platelet count ≥ 50 × 10\\^9\u002FL, Serum albumin ≥ 30 g\u002FL, Total bilirubin ≤ 2 ULN, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤ 2.5 × ULN, Alkaline Phosphatase (ALP) ≤ 2.5 × ULN, Creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 ml\u002Fmin, International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN;\n* Negative HIV test results at screening;\n* Hepatitis B virus (HBV) DNA\\\u003C500 IU\u002FmL;\n* No major vascular invasion (Vp3 or Vp4) of the portal vein or any level of major vascular invasion of the hepatic veins or inferior vena cava;\n* Within 7 days prior to screening, women of childbearing potential must confirm a negative serum pregnancy test and agree to use effective contraception during the study drug administration and for 60 days after the last dose of the study drug;\n\nExclusion Criteria:\n\n* Known cases of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;\n* HCC recurrence prior to study enrollment;\n* Co-infection with HBV and delta hepatitis virus;\n* Clinically significant ascites (Note: ascites detectable only through imaging studies are permitted to participate in the study);\n* History of hepatic encephalopathy;\n* Receipt of any other investigational drug treatment within 4 weeks prior to Day\n\n  1 of Cycle 1;\n* Presence of abdominal wall fistula, gastrointestinal perforation, refractory non-healing gastric ulcers, or history of active gastrointestinal bleeding within 6 months prior to enrollment;\n* History of another malignancy tumor , except for the cured skin basal cell carcinoma and cervical carcinoma in situ)\n* Active tuberculosis;\n* Functional impairment of major organs (heart, lungs, kidneys, etc.), severe infections, or \\> grade 2 adverse events (Common Terminology Criteria for Adverse Events (CTCAE) version 5.0);\n* Very early-stage HCC, solitary tumors, size \\\u003C 2 centimeters;\n* Any allergy to the drugs used in the TACE regimen or known components of epimedium soft capsules;\n* History of organ transplantation;\n* Pregnant or breastfeeding female patients, or those unwilling to use contraception during the trial;\n* Any other diseases, metabolic disorders, abnormal physical examination results, or laboratory test results that raise suspicion of contraindications for the investigational drug, may affect the reliability of study results, or place the patient at high risk for treatment complications, or affect patient compliance.","80 Years",{"count":137,"type":21},25,[139],"PHASE2","This is a prospective, single-center, phase II study，to evaluate the efficacy and safety of icariin soft capsules combined with TACE as adjuvant therapy in hepatocellular carcinoma (HCC) patients at high risk of recurrence after resection.",[37],"NOT_YET_RECRUITING","2025-03-27",{"date":145,"type":47},"2025-03-28",{"date":147,"type":21},"2025-03-30",{"date":149,"type":21},"2027-02-28",{"name":151,"class":82},"Hua Li",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":163,"conditions":164,"keywords":174,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":54},"100343753","phase-2-trans-arteryintra-tumor-infusion-of-checkpoint-inhibitors-plus-chemodrug-for-immunotherapy-of-advanced-solid-tumors-100343753","NCT03755739","Trans-Artery\u002FIntra-Tumor Infusion of Checkpoint Inhibitors Plus Chemodrug for Immunotherapy of Advanced Solid Tumors","A Phase II\u002FIII Trial of Comparison of Benefit of Administration of Checkpoint Inhibitors Plus Chemodrug Via Artery or Fine Needle to Tumor Versus Vein for Immunotherapy of Advanced Solid Tumors","Inclusion Criteria:\n\n1. Cytohistological confirmation is required for diagnosis of cancer.\n2. Signed informed consent before recruiting.\n3. Age above 18 years with estimated survival over 3 months.\n4. Child-Pugh class A or B\u002FChild score \\> 7; ECOG score \\\u003C 2\n5. Tolerable coagulation function or reversible coagulation disorders\n6. Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9\u002FL; Hb≥90g\u002FL； PLT ≥50×10E9\u002FL；INR \\\u003C 2.3 or PT \\\u003C 6 seconds above control；Cr ≤ 145.5 umul\u002FL；Albumin \\> 28 g\u002FL；Total bilirubin \\\u003C 51 μmol\u002FL\n7. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.\n8. Birth control.\n9. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.\n\nExclusion Criteria:\n\n1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;\n2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;\n3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;\n4. Patients accompanied with other tumors or past medical history of malignancy;\n5. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;\n6. Patients have poor compliance.\n\n   Any contraindications for hepatic arterial infusion procedure:\n\n   A.Impaired clotting test (platelet count \\\u003C 60000\u002Fmm3, prothrombin activity \\\u003C 50%).\n\n   B.Renal failure \u002F insufficiency requiring hemo-or peritoneal dialysis. C.Known severe atheromatosis. D.Known uncontrolled blood hypertension (\\> 160\u002F100 mm\u002FHg).\n7. Allergic to contrast agent;\n8. Any agents which could affect the absorption or pharmacokinetics of the study drugs\n9. Other conditions that investigator decides not suitable for the trial.",{"count":160,"type":21},200,[139,162],"PHASE3","This trial was designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by trans-artery\u002Fintra-tumor infusion of PD1\u002FPDL1 antibody and\u002For CTLA4 antibody ipilimumab plus chemotherapeutic drug and to compare their differences.",[37,165,166,167,168,169,170,171,172,173],"Lung Cancer","Melanoma","Renal Cancer","Head and Neck Cancer","Pancreas Cancer","Ovarian Cancer","Colo-rectal Cancer","Cervical Cancer","Breast Cancer",[175,176,177,178,179],"Solid cancers","Check-point inhibitors","Interventional Radiology","Trans-artery infusion","Intra-tumor injection","2024-06-22",{"date":182,"type":47},"2024-06-25",{"date":184,"type":47},"2018-11-01",{"date":186,"type":21},"2036-11-01",{"name":188,"class":82},"Second Affiliated Hospital of Guangzhou Medical University",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":54},"100500268","metabolic-profile-of-hepatocarcinoma-and-pancreatic-tumors-100500268","NCT05794048","METabolic PROFILE of Hepatocarcinoma and Pancreatic Tumors","PROMETHEP","Inclusion criteria :\n\nCommon criteria:\n\n* Patient aged 18 or over\n* Informed and having signed the consent to participate\n* Affiliated with a social security scheme or entitled\n\n  1- Patients with hepatocellular carcinoma\n* Having a HCC eligible for surgical treatment (liver resection or liver transplantation) not requiring preoperative anti-tumor treatment as validated by the multidisciplinary consultation meeting for primary hepatic tumors\n* OR having a HCC not eligible for curative treatment (liver resection, liver transplantation, tumor ablation), as validated by the multidisciplinary consultation meeting for primary hepatic tumors 2- Patients with pancreatic adenocarcinoma or pancreatic neuroendocrine tumor\n* Having ADKP or NET eligible for surgical treatment (duodenopancreatectomy, left pancreatectomy, enucleation, central pancreatectomy, hepatic metastasectomy) with or without preoperative anti-tumor treatment as validated by the multidisciplinary consultation meeting.\n* OR with an unresectable ADKP or TNEP, with only medical treatment plan as validated by the multidisciplinary consultation meeting\n\nExclusion criteria :\n\nCriteria common to all patients:\n\n* Pregnancy and lactation\n* Lack of informed, written and signed consent\n* Adult person subject to a legal protection measure or unable to express consent\n* Patient under State Medical Aid (AME)\n* Person deprived of liberty by a judicial or administrative decision\n* Person undergoing psychiatric care\n\n  1- Patients with hepatocellular carcinoma\n* Suspicion of mixed tumor (hepatocholangiocarcinoma) or intrahepatic cholangiocarcinoma\n* History of systemic or locoregional anti-tumor treatment in the target tumor\n* Contraindication to a liver biopsy\n* Decompensated cirrhosis 2- Patients with pancreatic adenocarcinoma or pancreatic neuroendocrine tumor\n* Suspicion of mixed tumor (MINEN) or intra-pancreatic cholangiocarcinoma\n* Contraindication to a pancreatic \u002F hepatic biopsy",{"count":197,"type":21},300,[24],"Hepatic (hepatocellular carcinoma (HCC)) and pancreatic (pancreatic adenocarcinoma (ADKP); pancreatic neuroendocrine tumors (TNEP)) primary tumors are the most common malignant tumors of the hepato-bilio-pancreatic system and represent a major public health issue. At present, the management of these tumors is based on recommendations based on the existence of rudimentary prognostic and theranostics markers that do not sufficiently accurately reflect the heterogeneity of tumor biology. It therefore seems essential to identify new and more relevant markers in order to optimize the care of these patients in daily practice.\n\nMetabolic reprogramming is now recognized as an essential feature of cancer cells, allowing them to fuel and maintain their proliferation and tumor growth. Such metabolic reprogramming requires modification of several energy pathways, the most commonly recognized being the transition from energy metabolism based on oxidative phosphorylation to energy metabolism based on glycolysis, even under aerobic conditions (Warburg effect). In this context, the investigators hypothesized that the consumption of nutrients by the tumor cell differs significantly from that of the normal cell in order to support its increased energy needs, and that this important and specific metabolic reprogramming would be correlated with the histo-prognostic and theranostics factors of these tumors. Preliminary analyses on surgical resection parts conducted by the various partners in 2019 made it possible to characterize the metabolic signatures of a series of HCC and ADKP resected using the Metafora biosystems technology platform. These signatures reflect a metabolic program characteristic of these tumors, which reveal strong specificities. Similarly, a candidate signature correlating with the presence of vascular microscopic invasion has been identified in HCC, and the level of activation of glycolysis and glutaminolysis by certain ADKP cells also appears as a trait of interest vis-à-vis the aggressiveness of this cancer.\n\nThus, the current project will aim to confirm the feasibility of identifying specific prognostic and theranostics metabolic signatures early, on biopsy samples and \u002F or circulating blood cells.",[37,201],"Pancreatic Tumor",[37,201],"2024-02-06",{"date":205,"type":47},"2024-02-07",{"date":207,"type":47},"2022-06-08",{"date":209,"type":21},"2026-09-08",{"name":211,"class":82},"Assistance Publique - Hôpitaux de Paris",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":228,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":54},"100519280","phase-2-adjuvant-therapy-for-high-risk-hepatocellular-carcinoma-post-liver-transplantation-100519280","NCT06041490","Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation","A Randomized, Controlled, Open-label, Multi-center Clinical Trial of Multi-kinase Inhibitor Combined With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma and High-risk Recurrence Factors After Liver Transplantation","Inclusion Criteria:\n\n1. Voluntary enrollment, accompanied by the signing of a written informed consent form, is a prerequisite for participation in this study. This ensures that participants enter the study based on their own decision and understanding of the research objectives, procedures, and potential risks.\n2. The study includes individuals aged between 18 and 75 years, inclusive, without any gender restrictions. This broad age range and gender inclusivity allow for a diverse representation of participants, facilitating a comprehensive understanding of the study outcomes across different demographic profiles.\n3. Prior to enrollment, participants must have undergone liver transplantation within the preceding 4 to 8 weeks. This specific time frame serves as an inclusion criterion to ensure that participants have recently undergone the surgical procedure, enabling researchers to investigate the effects of the transplantation within a relevant timeframe.\n4. Participants must have a confirmed pathological diagnosis of hepatocellular carcinoma (HCC) and meet at least one of the following criteria:\n\n   a) Pre-operative imaging or post-operative pathological confirmation of exceeding the Milan criteria.\n\n   b) Presence of major vascular invasion. c) Post-operative pathological confirmation of the presence of microvascular invasion (MVI).\n\n   d) Pre-operative imaging or post-operative pathological confirmation of the presence of satellite nodules.\n\n   e) Recurrence of HCC after liver resection and subsequent liver transplantation.\n5. Participants should have an anticipated life expectancy of more than 3 months.\n6. Participants should not have received systemic anti-tumor treatment prior to liver transplantation, with the exception of pre-operative transarterial chemoembolization (TACE), traditional Chinese medicine, and interferon treatment.\n7. Participants should have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1, indicating good functional status.\n8. Participants' liver function, as assessed by the Child-Pugh score, should be classified as Grade A, indicating well-preserved liver function.\n9. HBsAg-positive patients should receive continuous antiviral therapy post-transplantation, using first-line antiviral drugs such as entecavir, tenofovir, or tenofovir alafenamide.\n10. Participants should have adequate hematological and organ function, based on the laboratory test results obtained within 14 days before the initiation of the study treatment, as follows:\n\n    Laboratory tests (unless otherwise specified, no blood transfusion or use of G-CSF within 14 days prior to screening):\n    1. Hemoglobin ≥ 90 g\u002FL.\n    2. White blood cell count ≥ 3.0 x 10\\^9\u002FL.\n    3. Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL.\n    4. Platelet count ≥ 75 x 10\\^9\u002FL.\n\n       Biochemical tests (no use of albumin within 14 days prior to screening):\n    5. Serum albumin ≥ 28 g\u002FL.\n    6. Total bilirubin ≤ 2 times the upper limit of normal (ULN).\n    7. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times ULN.\n    8. Alkaline phosphatase (ALP) ≤ 5 times ULN.\n    9. Creatinine ≤ 1.5 times ULN or creatinine clearance (CrCl) \\> 50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula):\n\n       \\- For females: CrCl = ((140 - age) x body weight (kg) x 0.85) \u002F (72 x serum creatinine \\[mg\u002FdL\\]).\n       * For males: CrCl = ((140 - age) x body weight (kg) x 1.00) \u002F (72 x serum creatinine \\[mg\u002FdL\\]).\n\n       Coagulation Function:\n    10. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times the Upper Limit of Normal (ULN) or PT prolongation ≤ 6 seconds.\n    11. Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN.\n11. Women of Childbearing Potential: Women who agree to abstain from heterosexual intercourse during the treatment period and for at least 6 months after the last dose of the study drug, or use a contraceptive method with a failure rate of less than 1% per year. For women who have experienced menstrual bleeding and have not reached a postmenopausal state (continuous absence of menstruation for ≥12 months without any other known cause) and have not undergone sterilization procedures (removal of ovaries and\u002For uterus), they are considered to be of childbearing potential.\n\n    1. Examples of contraceptive methods with a failure rate of less than 1% per year include bilateral tubal ligation, male sterilization, hormone-based contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n    2. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial, patients' preferred lifestyle, and daily activities. Periodic abstinence methods (such as calendar-based methods, ovulation period methods, symptothermal methods, or post-ovulation methods) and withdrawal are not acceptable contraceptive methods.\n12. Men: Men who agree to abstain from heterosexual intercourse or use contraception and also agree not to donate sperm, as defined below:\n\n    1. If the female partner is of childbearing potential, male patients must abstain from heterosexual intercourse during the treatment period and for 6 months after the last dose of the study drug or use a condom plus another contraceptive method to achieve a contraceptive failure rate of \\\u003C1% per year. During the same period, male patients must also agree not to donate sperm. If the female partner is already pregnant, male patients must abstain from heterosexual intercourse or use a condom for contraception during the treatment period and for 6 months after the last dose of the study drug to avoid potential effects on the fetus.\n    2. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial, patients' preferred lifestyle, and daily activities. Periodic abstinence methods (such as calendar-based methods, ovulation period methods, symptothermal methods, or post-ovulation methods) and withdrawal are not acceptable contraceptive methods.\n\nExclusion Criteria:\n\nAccording to the information provided, the following patients are not eligible for participation in this study.\n\n1. Patients with a previous histological\u002Fcytological diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other similar components.\n2. Patients with a history of malignancies other than hepatocellular carcinoma, unless they meet the following criteria:\n\n   1. Patients who have undergone potentially curative treatment and have no evidence of the disease within the past 5 years.\n   2. Patients who have successfully undergone resection of basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or other in situ carcinomas; or patients who have been treated for superficial bladder cancer, have undergone surgical treatment, and have prostate-specific antigen (PSA) tumor markers within the normal range.\n3. Patients who are concurrently taking medications that may prolong the QTc interval and\u002For induce torsades de pointes (Tdp) or medications that affect drug metabolism.\n\n   Patients with a known or suspected history of allergies to sorafenib, lenvatinib, donafenib, or similar drugs.\n4. Patients with active bleeding or coagulation abnormalities, bleeding tendencies, or those undergoing thrombolysis, anticoagulant therapy, or antiplatelet therapy.\n5. Patients who have experienced thrombosis or thromboembolic events within the past 6 months, such as stroke and\u002For transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.\n\n7.Patients who have experienced esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months or any life-threatening bleeding event within the past 3 months. Patients with a history of gastrointestinal bleeding within the past 6 months or clear evidence of gastrointestinal bleeding tendencies, such as high-risk esophageal varices, locally active gastrointestinal ulcers, fecal occult blood ≥(++), are not eligible for inclusion. If fecal occult blood is (+), a gastroscopy examination is required. Evidence or history of bleeding mechanism disorders with ≥3 grade (CTC-AE 5.0) bleeding events, etc.\n\n8.Patients with clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction within the past 6 months, severe\u002Funstable angina or coronary artery bypass grafting, congestive heart failure (NYHA class \\>2), poorly controlled or requiring pacemaker therapy for arrhythmias, poorly controlled hypertension (systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg) despite medication.\n\n9.Other significant clinical and laboratory abnormalities that the investigator deems to impact safety assessment, such as uncontrolled diabetes, chronic kidney disease, peripheral neuropathy of grade II or higher (CTCAE V5.0), thyroid dysfunction, etc.\n\n10.Active or poorly controlled severe infections, including:\n\n1. HIV-positive (HIV1\u002F2 antibody).\n2. Active hepatitis B (positive for HBsAg or HBV DNA\\>2000 IU\u002Fml and abnormal liver function).\n3. Active hepatitis C (positive for HCV antibody or HCV RNA≥103 copies\u002Fml and abnormal liver function).\n4. Active tuberculosis.\n5. Other uncontrolled active infections (CTCAE V5.0 \\>2 grade). 11.Patients who have not yet recovered from surgery, with unhealed wounds or severe postoperative complications.\n\n   12.Patients with substance abuse or any medical, psychological, or social conditions that may affect the study, patient compliance, or potentially endanger patient safety.\n\n   13.Patients who have received treatment with potent CYP3A4 inhibitors (such as clarithromycin, indinavir, ketoconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole, etc.) within 7 days prior to study participation or potent CYP3A4 inducers (such as phenytoin, phenobarbital, primidone, carbamazepine, rifampin, rifabutin, rifapentine, St. John's wort, etc.) within 12 days prior to study participation.\n\n   14.Recipients of multiorgan transplantation. 15.Development of distant metastasis within 1 month after transplantation. 16.Participation in another clinical trial within the past 30 days. 17.Incomplete treatment duration of less than 3 months. 18.The investigator's comprehensive judgment deems the patient unsuitable for participation in this study.","75 Years",{"count":221,"type":21},88,[139],"1. Explore the impact of postoperative administration of multi-kinase inhibitors (including sorafenib, lenvatinib, and regorafenib) in conjunction with bevacizumab on post-transplant recurrence, overall survival, and drug safety in liver transplant recipients at high risk of recurrence in hepatocellular carcinoma.\n2. The primary objective of this study is to evaluate the efficacy of multi-kinase inhibitors in combination with bevacizumab as adjuvant therapy in liver transplant recipients with hepatocellular carcinoma who present high-risk factors for recurrence, based on the one-year recurrence-free survival rate (1-year RFS rate).\n3. The secondary objectives of this study are to assess the effectiveness and safety of multi-kinase inhibitors in combination with bevacizumab as adjuvant therapy in liver transplant recipients with hepatocellular carcinoma who present high-risk factors for recurrence, based on the following parameters: Recurrence-free survival (RFS) duration, Overall survival (OS), Two-year and three-year RFS rates, Graft survival, Quality of life evaluation (QoL), Incidence of adverse events and serious adverse events.",[225,37,226,227],"Liver Transplant; Complications","Recurrent Osteosarcoma","High-Risk Cancer",[37,229,230,231,232,233],"Liver Transplant","Recurrence","High-Risk","multikinase inhibitor","bevacizumab","2023-09-11",{"date":236,"type":47},"2023-09-18",{"date":238,"type":21},"2023-09",{"date":240,"type":21},"2027-01",{"name":242,"class":82},"Peking Union Medical College Hospital",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":54},"100518298","a-study-on-the-prevalence-of-clinically-useful-mutations-in-solid-tumor-characterized-by-next-generation-sequencing-methods-on-liquid-biopsy-analysis-popcorn-100518298","NCT06028724","A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)","A Prospective, Observational Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)","POPCORN","Inclusion Criteria:\n\nPatients eligible for inclusion in this study have to meet all of the following criteria:\n\n* Patients, 18 years of age or older\n* Competent and able to comprehend, sign and date an Ethics Committee (EC) approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n* Histologically proven diagnosis solid tumor\n* Diagnosis of advanced or locally advanced disease\n* Patients candidated to receive standard therapy in the following line:\n* first, second or third-line therapy for colon-rectal cancer in IV stage\n* first or second-line therapy for gastric cancer in IV stage\n* primary intent or first-line therapy for pancreatic cancer\n* first-line therapy for bile duct cancer\n* first or second-line therapy for hepatocarcinoma\n* first, second, third, fourth or fifth-line therapy for breast cancer in IV stage\n* chemotherapy for ovarian cancer in advanced stage (FIGO III-IV) and at the time of first relapse\n* first or second-line therapy for endometrial cancer in advanced stage (FIGO III-IV)\n* first or second-line therapy for advanced or locally advanced cervical cancer\n* therapy for locally advanced or first line therapy for metastatic vulva cancer\n* first, second or third-line therapy for melanoma (third-line therapy only in BRAF-mutated melanoma)\n\nExclusion Criteria:\n\n* Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.\n* Patients unable or unwilling to undergo as per protocol assessments at the four planned timepoints",{"count":252,"type":21},782,"The implementation of liquid biopsy in clinical practice has been favored by the rapid development of genome sequencing techniques designed to analyze mutations in ctDNA. Among these, the Next generation sequencing (NGS) is a technique that consists in sequencing several genomes in a short time span, collecting information about a wider range of genomic alterations, using small quantities of genetic material. It is used to identify potential circulating dynamic biomarkers of treatment sensitivity or resistance in a real word multi-pathology evaluation. In this way, defining the mutational status of clinical relevance genes in real world, as a predictive biomarker to identify those patients most likely to benefit from target therapy, offers the potential to optimize access to further therapies. The aim of this study is to evaluate the real-world prevalence of clinically useful mutations in patients who are receiving therapy for advanced and locally advanced solid tumor through liquid biopsy.",[255,256,257,258,259,260,261,37,173,170,262,172,263,166],"Solid Tumor","Advanced Solid Tumor","Locally Advanced Solid Tumor","Colon Rectal Cancer","Gastric Cancer","Pancreatic Cancer","Bile Duct Cancer","Endometrial Cancer","Vulva Cancer","2023-09-08",{"date":266,"type":47},"2023-09-13",{"date":268,"type":47},"2023-05-26",{"date":270,"type":21},"2030-05-31",{"name":272,"class":82},"Centro di Riferimento Oncologico - Aviano"]