[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatobiliary-cancers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatobiliary-cancers":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,75,104,148],{"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":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100535509","observational-study-protocol-liver-r-100535509",false,"NCT06252753","Observational Study Protocol: LIVER-R","An Observational Multi-Center Study to Evaluate Real-World Treatment Outcomes With or Without Durvalumab-Based Regimens in Hepatobiliary Cancers","LIVER-R","Inclusion Criteria General Inclusion Criteria\n\nAll patients must meet all of the following general criteria 1-4 along with all respective cohort specific criteria noted below:\n\n1. Age ≥18 years and a lawful adult in the country at the index date\n2. Confirmed presence of malignancy of primary hepatobiliary cancer by any method (e.g., radiological, histological, etc.)\n3. Decision to treat was made independently and prior to obtaining informed consent\n4. Informed consent was obtained as per country level regulations (includes waiver of consent for retrospective data collection if approved)\n\naBTC Specific Inclusion Criteria\n\nA patient will be eligible to be included in the aBTC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:\n\n1. Patient has unresectable aBTC\n2. Has received or is intending to receive a durvalumab-based regimen (may have been treated in an EAP)\n\nuHCC Specific Inclusion Criteria\n\nA patient will be eligible to be included in the uHCC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:\n\n1. Patient has unresectable uHCC\n2. Not eligible for LRT, as well as for those who progressed following LRT\n3. Has received or is intending to receive a durvalumab-based regimen (may have been treated in an EAP)\n\neeHCC Specific Inclusion Criteria\n\nA patient will be eligible to be included in the eeHCC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:\n\n1. HCC confirmed by radiological or histological diagnosis\n2. Child-Pugh A-B7\n3. Disease not amenable to curative treatment but amenable to LRT at index\n4. Patients with liver-confined HCC who initiated first non-curative intent LRT on or after 01 January 2024\n5. Patients eligible for LRT with palliative intent such as TACE\u002F TARE\u002Ftransarterial infusion chemotherapy (TAIC)\u002F hepatic arterial infusion chemotherapy (HAIC)\u002Ftransarterial embolization (TAE) given by itself or in combination with other systemic therapy (can include durvalumab) within 60 days of the LRT\n\nEMERALD Specific Inclusion Criteria\n\nA patient will be eligible to be included in the EMERALD cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:\n\n1. HCC confirmed by radiological or histological diagnosis\n2. Child-Pugh score of A-B7\n3. Liver-confined disease not amenable to curative treatment but amenable to LRT at index\n4. Receipt of a durvalumab-based regimen in combination with LRT administered within 28 days of each other (index is the first of the two treatments administered)\n\nExclusion Criteria\n\nGeneral Exclusion Criteria\n\nA patient will be excluded from participating in this study if they meet any of the following general criteria 1-2 or any cohort specific exclusion criteria:\n\n1. Currently\u002Fwas participating or plans to participate in any clinical trial for investigational treatment for hepatobiliary cancers on or after the diagnosis date until the index date\n2. Second primary malignancy prior to HCC or BTC diagnosis\n\naBTC Specific Exclusion Criteria\n\nA patient will be excluded from participating in the aBTC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:\n\n1. Received a liver transplant during the baseline period\n2. Received more than 1 cycle of Gemcitabine + Cisplatin for biliary tract cancer on or after diagnosis of unresectable, locally advanced or metastatic disease through the index date. Patients who received any systemic therapy while having early stage, resectable disease are eligible\n\nuHCC Specific Exclusion Criteria\n\nA patient will be excluded from participating in the uHCC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:\n\n1. Received a liver transplant during the baseline period\n2. Received other systemic therapies for hepatobiliary cancer indication on or after diagnosis date through the index date\n\neeHCC Specific Exclusion Criteria\n\nA patient will be excluded from participating in the eeHCC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:\n\n1. Eligible for curative therapy at the time of receiving LRT (ablation)\n2. Extrahepatic spread\n3. Portal vein tumor thrombosis (PVTT) of VP3\u002F4\n4. Receipt of systemic therapy prior to index LRT in the baseline period\n5. Liver transplant any time prior to index\n\nEMERALD Specific Exclusion Criteria\n\nA patient will be excluded from participating in the EMERALD cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:\n\n1. Eligible for curative therapy at the time of receiving LRT (ablation)\n2. Extrahepatic spread\n3. Portal vein tumor thrombosis (PVTT) of VP3\u002F4\n4. Receipt of systemic therapy prior to index LRT in the baseline period\n5. Liver transplant any time prior to index","ALL","18 Years","130 Years",{"count":21,"type":22},4000,"ESTIMATED","OBSERVATIONAL","Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications. LIVER-R is a multi-country, multi-center, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with or without a durvalumab-based regimen as part of routine clinical practice or early access program (EAP). The study design will include primary and secondary data collection. The primary objective of this study is to evaluate the effectiveness of regimens (durvalumab-based or otherwise) in real-world settings as measured by real-world overall survival. Other endpoints include demographics, clinical characteristics, clinically significant events of interest, treatment patterns, concomitant medications, treatment provider characteristics, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, time to treatment discontinuation, recurrence-free survival, and time to treatment recurrence).",[26],"Hepatobiliary Cancers",[28,29,30,31,32,33,34],"Hepatobiliary cancer","Unresectable hepatocellular carcinoma (uHCC)","embolization eligible uHCC (eeHCC)","Advanced biliary tract cancer (aBTC)","Durvalumab","Observatory","Real-world","RECRUITING","2026-08-12",{"date":38,"type":39},"2026-08-13","ACTUAL",{"date":41,"type":39},"2023-12-19",{"date":43,"type":22},"2030-12-30",{"name":45,"class":46},"AstraZeneca","INDUSTRY",159,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100558339","the-effect-of-nutrition-optimized-prehabilitation-on-perioperative-intervention-in-primary-hepatocellular-carcinoma-100558339","NCT06549829","the Effect of Nutrition-optimized Prehabilitation on Perioperative Intervention in Primary Liver Carcinoma","Nutrition-Optimized Prehabilitation's Impact on Perioperative Outcomes in Primary Liver Carcinoma: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients diagnosed with primary liver cancer.\n\n  * Patients between the ages of 18 and 80.\n\n    * Patients who are feasible for surgical treatment after clinical evaluation.\n\nExclusion Criteria:\n\n* Patients with liver metastases or combined with other tumors.\n\n  * Patients with allergy to the ingredients of nutritional preparations. ③Patients with severe malnutrition who cannot eat by mouth. ④Patients with hyperthyroidism, fistula, and combined digestive system diseases.","80 Years",{"count":57,"type":22},120,"INTERVENTIONAL",[60],"NA","The aim of this project is to investigate the effect of triple prehabilitation led by nutritional optimization in liver cancer patients' surgery. It improves the preoperative nutritional status of cancer patients, reduces the incidence of early postoperative complications, promotes postoperative recovery, and improves the quality of patients' survival. Patients were randomized into experimental and control groups based on exclusion and inclusion criteria. Nutritional interventions and exercise and psychological interventions for patients. Routine clinical blood tests will be performed at the time of enrollment, on the first day before surgery and on the first, third and fifth days after surgery. Enrolled patients were followed up by telephone or outpatient clinic at 1 month postoperatively.",[63,64,26],"Hepatocellular Carcinoma","Liver Carcinoma","2026-08-09",{"date":36,"type":39},{"date":68,"type":39},"2024-09-01",{"date":70,"type":22},"2026-10-31",{"name":72,"class":73},"Second Affiliated Hospital, Zhejiang University, School of Medicine","OTHER",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":85,"studyType":23,"phases":4,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":74},"100603876","effect-and-mechanism-of-alpps-operation-on-liver-regeneration-100603876","NCT07142213","Effect and Mechanism of ALPPS Operation on Liver Regeneration","Effect and Mechanism of Combined Hepatectomy and Portal Vein Ligation Staged Hepatectomy (ALPPS) on Liver Regeneration in Patients With Hepatobiliary Malignancy","Inclusion Criteria:\n\n1. Age: Patients aged 18 to 75 years\n2. Diagnosis established: A diagnosis of hepatobiliary malignancy (including hepatocellular carcinoma and cholangiocarcinoma) was confirmed and evaluated as suitable for ALPPS surgery\n3. Liver function status: preoperative Child-Pugh score A or B, MELD score ≤15, with sufficient liver function reserve for operation\n4. Tumor characteristics: bilobal or complex tumors of the liver with large tumor areas requiring ALPPS to ensure adequate residual liver volume (FLR\u002FTLV\\\u003C30% or FLR\u002FBW\\\u003C0.5)\n5. Preoperative assessment: Imaging showed that future liver residual (FLR) was insufficient to support standard hepatectomy, and liver volume must be increased by ALPPS\n6. FLR enlargement: Postoperative assessment of FLR enlargement as expected (at least 30% enlargement or FLR\u002FBW above 0.5) for a second procedure\n7. No distant metastases: No unresectable extrahepatic metastases, except for resectable lung metastases\n\nExclusion Criteria:\n\n1. Preoperative FLR insufficiency: Residual liver volume (FLR) did not increase sufficiently after the first step (\\\u003C30% increase or FLR\u002FBW \\\u003C0.5) to be suitable for the second step\n2. Extrahepatic metastasis: unresectable distant metastasis, such as extensive metastasis of bone, lung, etc\n3. Severe liver disease: very poor liver function before surgery, Child-Pugh grade C or severe liver sclerosis during surgery (e.g. Metavir≥F3 or 30% or more hepatic steatosis)\n4. Major comorbidities: Major illnesses such as severe cardiovascular disease, kidney failure, or respiratory failure that do not tolerate major surgery\n5. Postoperative complications: Serious postoperative complications (such as liver failure, infection, etc.) after the first step are not suitable for the second step\n6. Evaluation of adverse surgery: After the first procedure, FLR blood supply or function is abnormal, affecting liver regeneration\n7. Pregnancy and lactation: pregnant or lactating women","75 Years",{"count":84,"type":22},50,"1 Year","Hepatobiliary malignancies-principally hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCA)-are highly aggressive and often diagnosed at advanced stages. Curative-intent liver resection remains the standard for resectable disease; however, postoperative outcomes depend on an adequate functional future liver remnant (FLR). Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) induces rapid FLR hypertrophy and has expanded resection eligibility compared with conventional two-stage hepatectomy by shortening the interval to definitive resection.\n\nKey uncertainties persist regarding the quality of ALPPS-induced regeneration and its relationship to long-term oncologic outcomes, including recurrence and metastasis. This observational study enrolls patients deemed suitable for ALPPS at Peking Union Medical College Hospital. Perioperative care follows institutional standards; no therapeutic procedures are altered for research purposes. The investigators will collect clinically available liver tissue and relevant medical data obtained during standard surgical care to characterize cellular and molecular programs of regeneration across the ALPPS stages.\n\nHigh-throughput profiling-including single-cell and spatial transcriptomics-will be used to define cell-type composition, transcriptional states, and signaling pathways associated with regeneration. The primary objective is to describe cellular and gene-expression changes in regenerating liver induced by ALPPS. Secondary objectives include exploring associations between regenerative quality and short- and long-term clinical outcomes. Findings are expected to inform potential therapeutic targets and strategies to enhance safe regeneration and improve postoperative prognosis.",[88,26,89,90],"Hepato Cellular Carcinoma (HCC)","Liver Cancer","Liver Regeneration",[92,93,94],"liver regeneration","ALPPS","hepatectomy","2025-08-23",{"date":97,"type":39},"2025-08-26",{"date":99,"type":39},"2020-01-01",{"date":101,"type":22},"2028-12-31",{"name":103,"class":73},"Haitao Zhao, MD",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":58,"phases":113,"briefSummary":114,"conditions":115,"keywords":128,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":74},"100580294","high-resolution-pet-ct-specimen-imaging-for-the-perioperative-visualization-of-resection-margins-100580294","NCT06835426","High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins","High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins: an Exploratory Pilot Study","A. Inclusion Criteria:\n\n* able to understand treatment protocol and informed consent form\n* estimated by the investigator to be compliant for study participation\n\n  1\\. Fulfilling all group-specific inclusion criteria:\n* confirmed breast cancer with an indication to undergo breast conserving surgery\n* confirmed prostate cancer with an indication to undergo resective surgeryprostatectomy;\n* confirmed thyroid lesion with an indication to undergo resective surgery;\n* confirmed parathyroid adenoma with an indication to undergo resective surgery;\n* suspected basal cell carcinoma, squamous cell carcinoma or melanoma with an indication to undergo resective surgery;\n* suspected lesion in genitourinary sites (including bladder cancer, renal pelvis and ureter carcinoma, adrenal cortical carcinoma and renal cell carcinoma) with an indication to undergo resective surgery;\n* suspected lesion in the head \\& neck region with an indication to undergo resective surgery;\n* confirmed primary or secondary hepatobiliary cancer with an indication to undergo resective surgery;\n* patients undergoing biopsy after metabolic active lesions were detected on a PET scan.\n* suspected neuro-endocrine malignancies with an indication to undergo resective surgery.\n* suspected brain tumor with an indication to undergo resective surgery.\n* Suspected malignant and benign gastrointestinal lesions with an indication to undergo resective surgery.\n* suspected malignant thoracovascular lesions with an indication to undergo resective surgery\n\nB. Exclusion Criteria:\n\n* general or local contra-indications for resective surgery;\n* in case of FDG-based PET tracers: a blood glucose level over 200 mg\u002FdL on the day of surgery;\n* pregnancy or lactation;\n* participation in other clinical studies with a radiation exposure of more than 1 mSv in the past year.",{"count":112,"type":22},150,[60],"These are patients in whom a benign or malignant tumor was recorded requiring surgery. During that surgery, the surgeon will cut away the tumor as part of the treatment of the disease. In this process, it is important that the tumor is removed correctly and completely. To verify that the correct tissue was completely removed, the tissue is examined microscopically. However, a microscopic analysis takes a relatively long time and the result is not known until a few days after the surgery is completed. If that microscopic analysis should eventually reveal that the tumor was not completely removed, additional treatment is usually necessary. An assessment of the excised tissue during surgery would allow additional tissue to be excised in the same operation if necessary. Thus, in this way, additional treatments can also be avoided. This could lead to shorter treatment time and less emotional strain for the patient, as well as lower costs. To date, however, there are no effective techniques to do this.\n\nPositronEmissionTomography (PET) imaging can be used to image the tumor that needs to be excised. To do this, a tracer must be administered through the blood before the operation. This tracer is a slightly radioactive substance that can be detected by the PET camera even at low concentrations. This technique is already routinely used in the hospital to detect cancer or inflammatory tissue in the body. During this study, however, it's not the intention to look at the tumor while it is still in the patient's body, but rather after it has been cut out of the patient's body by the surgeon. To do this, the piece of tissue cut away will be scanned using a specially designed PET-CT scanner.\n\nThe overall goal of this study is to gain additional knowledge. More specifically, the investigators wish to determine which medical conditions may benefit from high-resolution PET-CT specimen imaging.",[116,117,118,119,120,121,122,26,123,124,125,126,127],"Breast Carcinoma","Prostate Cancer Surgery","Thyroid Cancer","Parathyroid Adenomas","Skin Cancer","Genitourinary Cancer","Head and Neck Cancer","Metabolic Abnormality","Neuro Endocrine Tumours","Brain Tumours","Gastro Intestinal Cancer","Thoracoscopic Surgery",[129,130,131,132,133,134,135,136,137,138],"resective surgery","perioperative high-resolution PET-CT specimen imaging","breast cancer","Prostate cancer","thyroid cancer","parathyroid cancer","head and neck cancer","neuro-endocrine malignancies","genitourinary malignacies","thoracovascular malignancies","2025-02-14",{"date":141,"type":39},"2025-02-19",{"date":143,"type":39},"2023-08-06",{"date":145,"type":22},"2027-06-30",{"name":147,"class":73},"Algemeen Ziekenhuis Maria Middelares",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":154,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":5},"100575871","familial-intrahepatic-cholestasis-related-genes-associated-with-disease-susceptibility-in-hepato-biliary-cancers-100575871","NCT06777914","Familial Intrahepatic Cholestasis-related Genes Associated with Disease Susceptibility in Hepato-biliary Cancers","Inclusion Criteria:\n\n* Instrumental or histological diagnosis of HBCs, defined as primary liver and\u002For biliary tumors (hepatocellular carcinoma, cholangiocarcinoma, hepatocholangiocarcinoma) occurring in patients without apparent underlying chronic liver disease or in the context of cryptogenic chronic liver disease;\n* Curative treatment through surgical resection of the neoplasm or liver transplantation\n* Diagnosis of CCLDs defined as:\n\n  1. GGT and\u002For alkaline phosphatase \\>1.5 times the normal values in two or more measurements taken at least 6 months apart,\n  2. A history of pruritus combined with \\[BA\\] \\>10 mmol\u002Fl for a period of ≥6 months.\n* Obtaining written informed consent\n\nExclusion Criteria:\n\n* Other documented causes of chronic liver disease that can justify the clinical phenotype include:\n\nPrimary biliary cholangitis Primary sclerosing cholangitis IgG4-related cholangiopathy Obstructive jaundice excluded by the demonstration of normal bile duct anatomy Negative virological tests for HBV, HCV, HEV Alcohol abuse Hemochromatosis Wilson's disease Alpha-1 antitrypsin deficiency","12 Months",{"count":156,"type":22},600,"This is a cross-sectional, multicenter tissue study with an exploratory aim to estimate the prevalence of genetic mutations that predispose individuals to diseases in the context of cholestatic disorders and hepatobiliary neoplasms. It is intended as a hypothesis-generating study for future empirical investigations.",[26,159,160],"Progressive Familial Intrahepatic Cholestasis (PFIC)","Cholestatic Liver Disease","2025-01-10",{"date":163,"type":39},"2025-01-16",{"date":165,"type":39},"2024-10-22",{"date":167,"type":22},"2027-10",{"name":169,"class":73},"IRCCS Azienda Ospedaliero-Universitaria di Bologna"]