[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepato-cellular-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepato-cellular-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,71,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100623164","psyliver-pilote-involvement-of-the-autonomic-nervous-system-in-hepatocellular-carcinoma-hcc-100623164",false,"NCT07393074","PSYLIVER-PILOTE: Involvement of the Autonomic Nervous System in Hepatocellular Carcinoma (HCC)","Involvement of the Autonomic Nervous System in Hepatocellular Carcinoma (HCC): a Pilot Psycho-behavioral and Neurophysiological Study","PSYLIVER-PILOT","Inclusion Criteria:\n\nGroup A:\n\n* Over 18 years of age\n* Affiliated with a social security system\n* Sufficient command of the French language to hold a conversation and read\n* Signature of an informed consent form\n* Compensated cirrhosis classified as CHILD-Pugh A with clinical indication for liver biopsy (either for the etiological diagnosis or confirmation of cirrhosis, or for the etiological diagnosis of liver damage)\n* Liver biopsy scheduled as part of routine care for a diagnosis of cirrhosis without HCC\n\nGroup B:\n\n* Over 18 years of age\n* Affiliated with a social security system\n* Sufficient command of the French language to hold a conversation and read\n* Signature of an informed consent form\n* Compensated cirrhosis classified as CHILD-Pugh A with clinical indication for liver biopsy (either for the etiological diagnosis of cirrhosis or its confirmation; or for the etiological diagnosis of liver damage)\n* Liver biopsy scheduled as part of routine care for the diagnosis of suspected HCC (based on standard imaging criteria)\n\nExclusion Criteria:\n\n* Personal history of cancer in the broad sense (including HCC prior to inclusion in the study)\n* Pregnant or breastfeeding women\n* Adults subject to legal protection measures (guardianship, curatorship)\n* Contraindications to trans-parietal liver biopsy: clinical or radiological ascites, coagulation disorders, curative anticoagulation that cannot be suspended, dilation of the bile ducts\n* Persons deprived of their liberty by judicial or administrative decision\n* Wearers of electronic implants (pacemakers, implantable cardioverter defibrillators, cochlear implants, brain implants, etc.)\n* Psychotic disorders\n* Degenerative neurological disorders (Parkinson's disease and related disorders, dementia, Korsakoff's syndrome, etc.)\n* Antiarrhythmic treatment:\n\n  * Class Ia: Disopyramide and Quinidine\n  * Class Ic: Flecainide and Propafenone\n* Neuroleptic psychotropic treatment affecting the ANS (haloperidol, chlorpromazine, olanzapine, clozapine, quetiapine), tricyclic antidepressants (e.g., amitriptyline, amoxapine, clomipramine, etc.)","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","Chronic liver diseases affect 1.5 billion people worldwide and can lead to cirrhosis and hepatocellular carcinoma (HCC), which ranks as the third leading cause of cancer-related mortality globally. Despite advances in the treatment of hepatitis B and C, metabolic diseases, and addiction, HCC incidence continues to rise. In France, between 2010 and 2015, the five-year survival rate for liver cancer (90% of which is HCC) was 18% for men and 19% for women. Treatment of HCC is based on the BCLC classification (Barcelona Clinic Liver Cancer), which evaluates both cancer progression and liver function (Child-Pugh classification). Patients at early stages (0 or A) have a survival rate of over 5 years, while those at more advanced stages (C or D) have significantly lower survival rates, highlighting the importance of better early detection tools.\n\nCurrent screening for HCC in cirrhotic patients involves biannual US-scan. However, ultrasound sensitivity for detecting tumors smaller than 2 cm is around 25%. Therefore, developing personalized strategies to predict and detect early-stage HCC is crucial to improving patient outcomes. Various clinical and biological scores have been developed to assess the risk of developing HCC in cirrhotic patients, but these scores remain imperfect. Molecular heterogeneity in HCC, as revealed by transcriptomic studies, could explain the variability in outcomes and treatment responses. This heterogeneity in occurrence, phenotype, and progression of HCC suggests individual singularities that are not yet well understood.\n\nThese individual singularities are likely linked to the autonomic nervous system (ANS), particularly in the central nervous system (CNS), which regulates various physiological processes. The ANS consists of the sympathetic nervous system (SNS), mainly adrenergic, and the parasympathetic nervous system (PNS), mainly cholinergic. These two systems function antagonistically but with different temporal dynamics. A better understanding of the interaction between tumor cells and their environment through the ANS could lead to the identification of new biomarkers to predict HCC development and therapeutic targets.\n\nThe role of the ANS in cancer development has been explored in various cancers, including prostate, stomach, pancreatic, breast, and ovarian cancers, where the ANS regulates inflammation and immune responses. In chronic liver diseases, the liver is innervated by both sympathetic and parasympathetic fibers, and this innervation plays a role in regulating metabolism, liver regeneration, and fibrosis progression. Chronic liver disease etiologies, such as alcohol consumption, metabolic syndrome, and viral hepatitis, disrupt the balance between the SNS and PNS, contributing to liver dysfunction. The severity of liver damage is linked to autonomic dysfunction, and heart rate variability, a marker of PNS activity, is correlated with survival in patients with terminal-stage HCC.\n\nOur recent research has shown that patients with HCC exhibit a reconfiguration of the intrahepatic ANS, with a consistent cholinergic orientation at the neuro-hepatic synapse. Patients with parasympathetic orientation (as compared to sympathetic orientation) have more aggressive tumors, shorter survival, and, from a pharmacological perspective, anticholinergics increase sensitivity to targeted HCC therapies. Tumor cells and cytotoxic lymphocytes are most strongly associated with cholinergic receptor enrichment and depletion, respectively.\n\nIn this context, the PSYLIVER-PILOTE study builds on these findings by investigating the involvement of the ANS in HCC through non-invasive extra-hepatic measures. The SNS and PNS are connected to brain regions involved in cognitive, emotional, and social information processing, such as the anterior cingulate cortex, insula, ventromedial prefrontal cortex, amygdala, and hypothalamus. These brain areas are involved in cognitive control and emotional processing. Additionally, experimental data from polyvagal theory and neurovisceral integration theory highlight the role of the ANS in regulating cognitive, emotional, and social processes, as well as psycho-behavioral traits. For instance, confronting a person with cognitive tasks and emotional or social information alters the balance of sympathetic and parasympathetic activity. Similar changes are observed in psycho-behavioral disorders like depression, emotional dysregulation, stress, and aggression.\n\nThus, the PSYLIVER-PILOTE study aims to identify extra-hepatic markers of ANS activity associated with HCC, analyzing both electrophysiological indices (from the peripheral nervous system) and psycho-behavioral indices (from the central nervous system). This project could open new avenues for early HCC detection and the development of personalized treatments",[27,28,29,30],"Hepato Cellular Carcinoma","Cirrhosis","Autonomic Nervous System","Central Nervous System",[32,33,34,35],"HCC","cirrhosis","ANS","NRS","RECRUITING","2026-04-23",{"date":39,"type":40},"2026-04-29","ACTUAL",{"date":42,"type":40},"2026-04-17",{"date":44,"type":21},"2028-04-17",{"name":46,"class":47},"Hospices Civils de Lyon","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":48},"100630615","phase-2-iit2025-03-yang-lift-hcc-100630615","NCT07489976","IIT2025-03-YANG-LIFT-HCC","Leveraging Immunotherapy For Tumor Downstaging to Milan Criteria in Patients With Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Age ≥ 18 at the time of signing the Informed Consent Form.\n2. Beyond UCSF criteria HCC with diagnosis confirmed histologically\u002Fcytologically, radiologically, or clinically per AASLD criteria, with life expectancy of at least 12 months.\n3. Histologically confirmed HCC via liver biopsy obtained within 3 months prior to initiation of study treatment as part of SOC. If no historical biopsy is available, a biopsy must be performed at screening for confirmation. Screening liver biopsy may be conducted as part of research activities if not performed per SOC practice.\n4. ECOG performance status ≤ 2 within 7 days prior to initiation of study treatment.\n\n   Child-Pugh A or B7 (5 to 7 points) at screening and within 7 days prior to study treatment. D1 ECOG\u002FCTP may not repeat if screening ECOG\u002FCTP collected within 7 days prior to D1.\n5. HCC with Measurable disease by mRECIST (see Appendix 11.2) (at least one ≥10mm target lesion) that is not suitable for resection per standard clinical practice and beyond UCSF criteria (see section 11.5) confirmed with most recent imaging obtained within 3 months prior to screening.\n6. For subjects of childbearing potential (SOCBP), negative serum or urine pregnancy test and agreement to use adequate contraception or abstinence from the time of screening until 3 months following the last dose of Durvalumab.\n7. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* 1- Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC.\n\n  2- Extrahepatic spread with organ involvement other than liver. 3- Portal vein tumor thrombus (VP3-4) or any viable hepatic vein tumor thrombus at screening.\n\n  4- History of immune therapy exposure (and-PD-1, and PDL-1, and anti-CTLA-4) treatment.\n\n  5- Is pregnant or breastfeeding or expecting to conceive or impregnate someone during the study period.\n\n  6- Active or history of autoimmune diseases, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis.\n\n  7- Patient lacks interest or inadequate psychosocial support for organ transplantation.\n\n  8- Patients who have a known concurrent malignancy that is progressing or requires active treatment, who have not completely recovered from prior treatment, or who have a significant malignancy history that, in the opinion of the investigator, should preclude participation.\n\n  9- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n\n  10- Active tuberculosis (TB), as documented by a positive purified protein derivative (PPD) skin test or TB blood test and confirmed by a positive chest X-ray within 3 months prior to initiation of study treatment.\n\n  11- Active co-infection with HBV and HCV. Participants with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV.\n\n  12- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact participant safety.\n\n  13- Treatment with investigational therapy within 28 days prior to initiation of study treatment.\n\n  14- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment.\n\n  15- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[TNF\\] agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n  * Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible.\n  * Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n\n    16- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment, within 5 months after the final dose of ICI.\n\n    17- Radiotherapy within 28 days, or abdominal\u002Fpelvic radiotherapy within 60 days, prior to initiation of study treatment.\n\n    18- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment; or abdominal surgery, abdominal interventions, or significant abdominal traumatic injury within 60 days prior to initiation of study treatment; anticipation of need for major surgical procedure during the course of the study; or non-recovery from side effects of any such procedure.\n\n    19- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of the study drugs, may affect the interpretation of the results, or may render the participant at high risk from treatment complications",{"count":57,"type":21},41,[59],"PHASE2","The investigators are doing this study to learn if a combination of immunotherapy and a liver-directed tumor procedure can safely and effectively shrink or control liver cancer (hepatocellular carcinoma, HCC). The goal is to try to lower the stage of the cancer so that more patients may become eligible for a liver transplant. The investigators will also closely watch for side effects from the study treatments. Section 2 has more details.",[27],"2026-03-23",{"date":64,"type":40},"2026-03-27",{"date":66,"type":21},"2026-04-01",{"date":68,"type":21},"2030-12-31",{"name":70,"class":47},"Ju Dong Yang",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100568007","leopard-training-and-validation-data-collection-study-100568007","NCT06675604","LEOPARD Training and Validation Data Collection Study","Data Collection to Design and Validate LEOPARD Predictive Models of Delisting in Liver Transplant Candidates","LEOPARD TVDCS","Inclusion Criteria:\n\n* Adult \\[age 18;70\\] patients listed for:\n\n  * decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology (subset 1) OR\n  * other chronic end-stage liver diseases requiring LT, to be listed under a MELD-based allocation system (examples: primary biliary cholangitis, primary sclerosing cholangitis etc…) (subset 2) OR\n  * HCC\\* as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis (subset 3). (HCC diagnosed on Barcelona\u002FEASL criteria or histologically proven. HCC meeting or not Milan criteria, as per center practice.)\n* Patients registered on national waiting lists under the MELD offering schemes, regardless of extra MELD points and MELD exceptions are affected or not.\n* Patient (or trusted person, family member or close relation, if the patient is unable to be informed) who has been informed and did not express opposition to data collection\n\n(\\*Of note, enrolment of patients with T1 tumors (1 single tumor \\\u003C 2 cm diameter) not amenable to loco-regional therapies because of decompensation, and prioritized under the MELD system, will be allowed in Subset 1.)\n\nExclusion Criteria:\n\n* Tumor vascular invasion (portal or hepatic veins) evidenced by imaging at pre transplantation work-up, including portal vein thrombosis stage 1\n* Extra-hepatic metastasis of HCC, as assessed by sectional imaging, functional imaging (18 FDG PET CT\u002FMRI) or histologically proven\n* Patients who are under safeguard of justice or tutorship or curatorship\n* Patient on AME (state medical aid)\n* Participation to LEOPARD PVC 1 study of WP2","70 Years",{"count":81,"type":21},4500,"OBSERVATIONAL","Intro:\n\nThe present clinical research protocol is part of the LEOPARD European project (Grant n° 101080964 Horizon Europe) which aims to design and validate new predictive models of mortality among liver transplantation (LT) candidates. MELD based-liver graft allocation systems have become increasingly inaccurate over the last decade to predict mortality\u002Fdropout of liver transplantation (LT) candidates on the waitlist (WL). Wide disparities in mortality\u002Fdropout on the WL also exist across European countries, ranging from 5 to 30% according to transplantation indications and countries. In this setting, the European Commission- Horizon Europe funded-LEOPARD project intends to design new, 2nd generation, AI-machine learning-based predictive models of delisting in LT candidates, to better serve on time patients with the highest risk of dropout on the WL and to improve equity of access to LT across Europe.\n\nHypothesis\u002FObjective:\n\nThe scientific justification of the LEOPARD TVDCS is therefore to collect a large set of data in liver transplantation candidates listed in Europe a) to design and b) to validate LEOPARD 2nd generation AI-based predictive models of mortality\u002Fdropout The primary objective is to develop new predictive models of mortality\u002Fdrop out on the waitlist in patients with decompensated cirrhosis, or other end-stage chronic liver diseases, and in patients listed for Hepato-cellular carcinoma (HCC).\n\nMethod:\n\nLongitudinal multicenter prospective health care data collection cohort study in 2 sets : Training\u002Fdevelopment set : Prospective health care data collection in 3,000 patients listed in 50 centres across 7 countries and Validation set: Prospective health care data collection in 1,500 subsequent patients listed in the same 50 centres.",[85,86,87,88],"Decompensated Liver Cirrhosis","Primary Biliary Cholangitis","Primary Sclerosing Cholangitis","Hepato-cellular Carcinoma",[90,91,92,93],"Liver transplantation","predictive models","data collection cohort","liver transplantation candidates","2025-05-06",{"date":96,"type":40},"2025-05-09",{"date":98,"type":40},"2025-02-04",{"date":100,"type":21},"2029-02-04",{"name":102,"class":47},"Assistance Publique - Hôpitaux de Paris",22,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":112,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100571670","leopard-prospective-validation-cohort-1-100571670","NCT06723275","LEOPARD Prospective Validation Cohort 1","Validation of LEOPARD Predictive Models of Delisting in Liver Transplant Candidates: the LEOPARD Longitudinal Multicentre Prospective Validation Cohort 1, with Bio- and Tissue Collection","LEOPARD PVC1","Inclusion Criteria:\n\n* Adult \\[age 18;70\\] patients listed for:\n\n  * decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology (subset1) OR\n  * other end-stage liver diseases requiring LT, listed under MELD offering schemes (subset 2), including notably but not exclusively cholestatic diseases, primary biliary cholangitis, primary sclerosing cholangitis (subset 2) OR\n  * HCC as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis (subset 3). (HCC diagnosed on Barcelona\u002FEASL criteria or histologically proven. HCC meeting or not Milan criteria, as per center practice.)\n* Patients registered on national waiting lists under the MELD offering schemes, regardless of extra MELD points are affected or not.\n* Patient (or trusted person, family member or close relation, if the patient is unable to express consent) who has been informed and signed the informed consent.\n* Patient affiliated with a health insurance scheme (beneficiary or entitled party).\n\nExclusion Criteria:\n\n* Tumor vascular invasion (portal or hepatic veins) evidenced by imaging on pre transplantation work-up, including PVT stage 1\n* Extra-hepatic metastasis of HCC, as assessed by sectional imaging, functional imaging (18 FDG PET CT\u002FMRI) or histologically proven\n* Women who are pregnant or nursing\n* Patients who are under safeguard of justice or tutorship or curatorship\n* Patient on AME (state medical aid)\n* Participation in another trial including other studies proposed as part of the European LEOPARD project (cohort associated to WP1 \\& WP5 (\"LEOPARD TVDCS\") or being in the exclusion period following previous interventional research involving the human person, if applicable",{"count":113,"type":21},630,"Intro:\n\nThe present clinical research protocol is part of the LEOPARD European project (Grant n° 101080964 Horizon Europe) which aims to design and validate new predictive models of mortality among liver transplantation (LT) candidates.\n\nMELD based-liver graft allocation systems have become increasingly inaccurate over the last decade to predict mortality\u002Fdropout of liver transplantation (LT) candidates on the waitlist (WL). Wide disparities in mortality\u002Fdropout on the WL also exist across European countries, ranging from 5 to 30% according to transplantation indications. In this setting, the European Commission- Horizon Europe funded-LEOPARD project intends to design new, 2nd generation, AI-machine learning-based predictive models of delisting in LT candidates, to better serve on time patients with the highest risk of dropout on the WL and to improve equity of access to LT across Europe.\n\nHypothesis\u002FObjective The scientific justification of the LEOPARD PVC1 is therefore\n\n1. to build an external cohort of LT candidates to test and validate the LEOPARD models, therefore providing robust evidence for adoption of LEOPARD models by Organ Sharing Organizations (OSOs).\n2. to collect granular data, bio- and tissues sampes and images to test last-generation OMICs predictors and radiomics, therefore opening the door to design of 3rd generation, precision medicine-based predictive models.\n\nThe primary objective of the LEOPARD longitudinal study is to test and validate AI-based 2nd generation LEOPARD predictive models of mortality\u002Fdrop out on the waitlist in patients with decompensated cirrhosis, or other end-stage chronic liver diseases, and in patients listed for HCC.\n\nMethod Multicenter Prospective longitudinal study in up to 630 enrolments (in case of replacing participants after inclusion) to obtain 600 patients meeting selection criteria, in 30 hospitals in 5 European countries including France, Italy, The Netherlands, Belgium and Germany.",[85,86,87,88],[90,117,118,119],"Predictive models","Liver transplantation candidates","prospective longitudinal study","NOT_YET_RECRUITING","2024-12-10",{"date":123,"type":40},"2024-12-13",{"date":125,"type":21},"2025-01",{"date":127,"type":21},"2027-10",{"name":102,"class":47},5]