[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-metastases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-metastases":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,68,0,25,[9,58,91,122,145,175,209,248,269,295,323,349,371,392,419,446,468,496,523,561,581,610,635,666,687],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100648846","ct-volumetry-and-hepatic-vascular-deformation-mapping-to-predict-post-hepatectomy-liver-failure-100648846",false,"NCT07727759","CT Volumetry and Hepatic Vascular Deformation Mapping to Predict Post-Hepatectomy Liver Failure","Beyond Size - Integrating CT Volumetry With Hepatic Vascular Deformation Mapping to Anticipate Post-Resection Congestion and Liver Failure","BEYOND-SIZE","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled to undergo major hepatic resection, defined as the removal of three or more Couinaud segments, at a participating center\n* Availability of a preoperative multiphasic contrast-enhanced CT of the liver of quality sufficient for central core-laboratory analysis\n* Willing and able to complete postoperative clinical and laboratory follow-up for at least 30 days\n* Written informed consent\n\nExclusion Criteria:\n\n* Minor hepatic resection (fewer than three Couinaud segments)\n* Significant pre-existing vascular anomaly or vascular pathology (for example, portal vein thrombosis)\n* Emergency hepatic resection for trauma\n* Preoperative imaging that fails central quality control\n* Incomplete follow-up data","ALL","18 Years",{"count":21,"type":22},1070,"ESTIMATED","OBSERVATIONAL","Removing a large part of the liver (major hepatectomy) can cure primary and secondary liver cancers, but it carries the risk of post-hepatectomy liver failure (PHLF), a serious complication in which the liver left behind - the future liver remnant (FLR) - cannot meet the body's metabolic needs. PHLF occurs after roughly 5% to 15% of major hepatectomies and is the leading cause of postoperative death.\n\nBefore surgery, surgeons routinely use CT scans to measure how much liver will remain (CT volumetry). Volume alone does not tell the whole story. After a large resection the remaining liver can rotate and shift into the empty space left behind, kinking or compressing the veins that drain it. The resulting congestion can make an apparently adequate remnant fail.\n\nThis prospective, multicenter, observational cohort study tests whether adding two elements to standard CT volumetry improves the preoperative prediction of liver failure:\n\n1. Hepatic vascular deformation mapping (VDM), a three-dimensional image-analysis technique that quantifies the geometry and displacement of the hepatic veins and the portal vein; and\n2. A set of simple, reproducible measurements that any radiologist can make on a standard CT scan (hepatic vein diameters, congestion index, spleen volume, liver attenuation, and the distances from the veins to the planned resection plane).\n\nConsecutive adults undergoing major hepatic resection (three or more Couinaud segments) at several tertiary hepatobiliary centers will be enrolled. The preoperative CT scans already performed as part of routine care are analyzed centrally by a core imaging laboratory. There is no additional imaging, no extra hospital visit, and no study-specific intervention: every patient receives standard surgical care. Participants are followed for at least 30 days after surgery to record liver failure (International Study Group of Liver Surgery criteria, operationalized by the \"50-50\" rule on postoperative day 5) and radiologic evidence of hepatic congestion.\n\nThree nested prediction models are compared - volumetry alone; volumetry plus VDM; and volumetry plus VDM plus the simple radiology parameters - and the best-performing model is converted into a practical risk score. Because the study runs across several centers, the model can be validated by leaving one center out at a time, which gives an honest estimate of how well it would perform at a new hospital. The goal is a generalizable, easy-to-use tool that tells surgeons, before the operation, which patients are genuinely at risk of post-hepatectomy liver failure.",[26,27,28,29,30,31,32],"Post-Hepatectomy Liver Failure","Liver Failure","Liver Neoplasms","Carcinoma, Hepatocellular","Liver Metastases","Postoperative Complications","Hepatic Congestion",[34,35,36,37,38,39,40,41,42,43,44],"post-hepatectomy liver failure","CT volumetry","future liver remnant","vascular deformation mapping","hepatic venous congestion","major hepatectomy","clinical prediction model","ISGLS criteria","congestion index","hepatobiliary surgery","risk stratification","RECRUITING","2026-08-17",{"date":48,"type":49},"2026-08-18","ACTUAL",{"date":51,"type":49},"2026-08-15",{"date":53,"type":22},"2028-07-31",{"name":55,"class":56},"Minia University","OTHER",3,{"id":59,"slug":60,"hasResults":12,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":68,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100614263","phase-1-neoadjuvant-dupilumab-and-toripalimab-in-mss-crc-subjects-with-resectable-liver-metastases-100614263","NCT07277322","Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases","Master Protocol for A Phase 1b\u002F2 Study of Neoadjuvant Immunotherapy in Microsatellite Stable (MSS) Colorectal Cancer (CRC) Subjects With Resectable Liver Metastases","INCLUSION CRITERIA:\n\nHistological diagnosis of non-MSI-H\u002FpMMR CRC\n\n• Subjects who have biology-proven non-MSI-H\u002FpMMR CRC and with radiographic findings suggestive of liver metastases may be eligible.\n\nResectable liver metastases including:\n\n* synchronous liver metastases (present at the time of diagnosis of MSS CRC) and treatment-naïve\n* metachronous liver metastasis (developed after resection of the primary tumor) without prior adjuvant chemotherapy\n* metachronous liver metastasis (developed after resection of the primary tumor) with adjuvant chemotherapy completed greater than 3 months from the time of consent.\n\nSurgical candidate for resection\n\nAge ≥ 18 years. Rationale: Because no dosing or adverse event data are currently available on the use of dupilumab in combination with toripalimab in subjects \\\u003C18 years of age, children are excluded from this study.\n\nECOG Performance Status 0-1 (Karnofsky ≥60%,)\n\n• Subjects with performance status \\>1 carrying long-term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy may be enrolled at the investigator's discretion\n\nWomen of child-bearing potential (WOCBP) and men must agree to use adequate contraception upon study entry, for the duration of study participation, and for 3 months following completion of therapy.\n\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n  * Has not undergone a hysterectomy or bilateral oophorectomy; or\n  * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n\nAbility to understand and the willingness to sign a written informed consent. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nAdequate organ and marrow function as defined:\n\n* Hematologic\n\n  o Absolute neutrophil count (ANC) ≥1,000 \u002FmcL\n  * Platelets ≥75,000 \u002FmcL\n  * Hemoglobin ≥8 g\u002FdL\n* Renal\\* o Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated (Creatinine clearance should be calculated per institutional standard) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥45 mL\u002Fmin for subjects with creatinine levels \\> 1.5 X institutional ULN\n* Hepatic\\* o Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN; ≤ 3 X ULN for subjects with liver metastases o AST ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n\n  * ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n  * Albumin \\>2.5 mg\u002FdL\n* Coagulation\\*\n\n  * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT is within therapeutic range of intended use of anticoagulants\n  * Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants \\* If laboratory criteria are not met due to what the investigator determines to be a biologic cause (e.g. Gilbert's syndrome causing elevated bilirubin or excessive muscle mass affecting creatinine) or drug-related cause (e.g. elevating in transaminases due to HAART therapy, elevated INR due to anticoagulation) then the lab values will not be used to exclude subject from this trial. This determination will be made by PI.\n\nEXCLUSION CRITERIA:\n\nHistory of autoimmune disorder with the following exceptions:\n\n* Vitiligo, alopecia, psoriasis or any chronic skin condition that does not require systemic therapy\n* Hypothyroidism (e.g. following autoimmune thyroiditis) stable on thyroid replacement\n* Celiac disease controlled by diet alone\n\nTreatment, for any reason, with an immunomodulatory drug, within 8 weeks from time of consent.\n\nPrior treatment with dupilumab within the last 8 weeks.\n\nPrior treatment with chemotherapy for MSS CRC or locoregional therapy to the target lesion (that will be biopsied and subsequently resected) within 3 months prior to entering the study.\n\n• Previous therapy for a different cancer (a different primary) is acceptable.\n\nUse of investigational agents for treatment of cancer.\n\nSubjects with extrahepatic metastases that are not amendable to resectable or locoregional therapy, for whom the intent of surgery would not be curative.\n\nUncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10 days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, as determined the treating investigator.\n\nPregnant or nursing women due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n\n• Breastfeeding should be discontinued prior to study enrollment.\n\nHas a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n\n• Chronic steroids equivalent to ≤ 10mg prednisone are permitted.\n\nHas active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n\n• Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted.\n\nHas a known additional malignancy that is progressing and requires active treatment.\n\n• Exceptions include: basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical or anal cancer, prostate cancer on stable dose of hormonal therapy without rising PSA, and breast cancer treated with curative intent now on hormonal therapy.\n\nHas a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.\n\nHIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with \\\u003C200 CD4+ T cells\u002Fmicroliter in the peripheral blood. HIV testing is mandatory for patients with no known history of HIV. For such patients, HIV testing will be considered SOC.\n\nHas known active Hepatitis B (e.g., HBV detected by PCR (\\>200 IU\u002Fml) or known active Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n\n• Subjects who started antiviral therapy \\>\u002F=14days from baseline are permitted.\n\nHistory of allogeneic hematopoietic cell transplantation or solid organ transplantation.\n\nDocumented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps) Principle investigator believes that for one or multiple reasons the subject will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the subject.",{"count":66,"type":22},24,"INTERVENTIONAL",[69,70],"PHASE1","PHASE2","This Phase 1b\u002F2 trial will evaluate the safety and efficacy of neoadjuvant immunotherapy in microsatellite stable (MSS) colorectal cancer (CRC) subjects with resectable liver metastases.",[73,30],"Metastatic Colorectal Cancer",[75,76,77,78,79,80],"Colorectal cancer","Liver metastases","Neoadjuvant immunotherapy","Dupilumab","Toripalimab","microsatellite stable","2026-08-10",{"date":83,"type":49},"2026-08-12",{"date":85,"type":22},"2026-09-01",{"date":87,"type":22},"2030-12-31",{"name":89,"class":56},"Dan Feng",1,{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":67,"phases":101,"briefSummary":103,"conditions":104,"keywords":109,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":90},"100585191","hepquant-study-to-assess-the-role-of-blood-based-biomarkers-and-quantitative-mr-imaging-for-patients-receiving-radiation-therapy-for-liver-cancer-100585191","NCT06899152","HepQuant: Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer","HepQuant: Pilot Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer","HepQuant","The following criteria must be met for subjects to be considered for the trial. Additional exclusion criteria must be met for subjects interested in the HepQuant subset of the trial. The first 20 qualifying subjects will be enrolled for the additional HepQuant test.\n\nInclusion Criteria:\n\n* Age \\> 18\n* Patient has the psychological ability and general health needed to provide informed consent, completion of study requirements, and required follow-up\n* Patient provides study-specific informed consent prior to study entry\n* All primary histologies (Hepatocellular carcinoma or Cholangiocarcinoma) as well as hepatic metastases are eligible\n* Prior history of radiation therapy (external beam or radioembolization) is allowed, with no limit to the number of prior courses of radiation therapy\n* Any number of lesions (with no size limit) of pathologically documented (histologically or cytologically) or radiographically proven tumor\u002Fmetastasis that are being targeted\n* Prior history of liver resection, transarterial chemoembolization (TACE), or ablation are allowed with no restriction on number of prior therapies, or time from current study registration\n* Prior history of chemotherapy, immunotherapy, or targeted biological therapy is allowed\n* Concurrent enrollment on other prospective registry or treatment intention trials is allowed\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding females\n* Subjects with history of claustrophobia impacting ability to perform MRI during the study\n* Subjects who fulfill any of the contraindications for MRI; examples include any ferromagnetic material, any metallic shrapnel or fragments or implanted electronic devices contained within the body or metal-containing tattoos\n* Unable to participate in MR assessments due to physical limitations of equipment tolerances (MRI bore size and\u002For weight limit)\n* Any person unable to lie still within the environment of the MRI scanner or maintain a breath hold for the required period to acquire images\n\nExclusion criteria for HepQuant SHUNT DuO testing ONLY:\n\n* Known history or suspected hypersensitivity to human serum albumin, or its preparations\n* Subjects with extensive resection of large segments of small intestine (short gut) or severe gastroparesis (e.g., diabetic or medication-induced gastroparesis)\n* Subjects on either a non-selective beta blocker (propranolol, nadolol), or an angiotensin converting enzyme (ACE) inhibitor, or angiotensin receptor blocker (ARB) who are unwilling or unable to delay taking their normal dose the morning of their testing\n* Subjects who are allergic to any ingredient in the formulations or components in the HepQuant SHUNT DuO kit including the human serum albumin (HSA) or cholate compounds (theoretical - none yet reported)\n* Subjects unwilling or unable to fast for at least 5 hours. Fasting means no intake of food or food supplements, including fiber preparations or biosimilars; or any preparations or resins (cholestyramine, colestipol, colesevelam) that might act within the gut lumen to bind the orally administered d4-cholate in the HepQuant test.",{"count":100,"type":22},40,[102],"NA","This is a pilot and feasibility study assessing the role of quantitative multiparametric MRI and blood-based biomarkers for the measurement of liver function in patients receiving radiation therapy for liver cancer, including hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver metastases regardless of primary histology, that are undergoing photon radiation either in the de-novo or re-irradiation setting. The goal of this study is to prospectively evaluate the feasibility of using quantitative multiparametric MRI to monitor liver function at baseline and following liver radiation therapy.",[105,106,107,108,30],"Liver Cancer","Hepatocellular Carcinoma","Hepatocellular Cancer","Cholangiocarcinoma",[110,111,112],"Blood-based biomarkers","Quantitative MR imaging","Radiotherapy","2026-08-07",{"date":115,"type":49},"2026-08-11",{"date":117,"type":49},"2025-07-16",{"date":119,"type":22},"2031-07",{"name":121,"class":56},"Montefiore Medical Center",{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":129,"targetDuration":131,"studyType":23,"phases":4,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":141,"leadSponsor":143,"locationsCount":4},"100650323","radiogenomic-profiling-of-dendritic-cells-and-macrophages-to-predict-recurrence-in-colorectal-liver-metastasis-100650323","NCT07744139","Radiogenomic Profiling of Dendritic Cells and Macrophages to Predict Recurrence in Colorectal Liver Metastasis","RaP-DMac-LiMe","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed colorectal liver metastases.\n* Administration of neoadjuvant chemotherapy prior to liver resection, with objective tumour response classified as partial response (PR) or stable disease (SD) according to RECIST criteria.\n* Availability of a hepatobiliary contrast-enhanced MRI performed within 2 months before surgery.\n* Provision of informed consent for prospectively enrolled participants, or eligibility under Article 110-bis of the Italian Privacy Code for retrospectively enrolled participants.\n\nExclusion Criteria:\n\n* Recurrent metastatic disease.\n* Liver resection performed with non-curative intent.\n* Current or previous hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n* Concomitant malignancies or history of another malignancy treated within the previous 5 years.",{"count":130,"type":22},210,"24 Months","The RaP-DMac-LiMe study (Radiogenomic Profiling of Dendritic Cells and Macrophages to Predict Recurrence in Colorectal Liver Metastasis) is a monocentric, non-profit observational study promoted by Fondazione Policlinico Universitario A. Gemelli IRCCS. Its primary aim is to identify immunological, genomic, and radiomic biomarkers associated with recurrence risk in patients with colorectal liver metastases (CRLM) undergoing curative-intent liver resection.\n\nThe study is based on the need to improve prognostic stratification in CRLM by integrating information from the tumor immune microenvironment, tumor genomics, radiomics, and clinical data. Particular attention is given to myeloid immune cells, especially dendritic cells and tumor-associated macrophages, whose role in metastatic progression and recurrence remains insufficiently understood.\n\nThe primary objective is to assess the association between myeloid immune profiles and recurrence risk through integrated molecular, spatial, genomic, and radiological analyses. Secondary objectives include characterizing the transcriptomic and genomic features of dendritic cells and macrophages, identifying radiomic and circulating tumor DNA (ctDNA) biomarkers, and evaluating their potential as non-invasive tools for recurrence prediction and patient stratification.\n\nThe study includes a retrospective cohort of approximately 160 patients treated between 2009 and 2023 and a prospective cohort of approximately 50 patients who will be followed for 24 months. Tumor tissue samples, peripheral blood, imaging data (CT\u002FMRI), and clinical information collected during routine care will be analyzed without introducing any experimental interventions or deviations from standard clinical practice.\n\nAnalyses will include transcriptomic profiling, multiplex spatial characterization of immune cells, circulating tumor DNA sequencing using next-generation sequencing technologies, radiomic feature extraction, and integration of all data using statistical and machine learning approaches. Predictive models will be trained on retrospective data and independently validated in the prospective cohort.\n\nThe primary endpoint is the prediction of colorectal liver metastasis recurrence within two years after liver resection. Ultimately, the study aims to develop and validate a multimodal predictive model integrating immune, genomic, radiomic, and clinical variables to improve recurrence risk assessment and support personalized patient management.\n\nThe overall study duration is 36 months. All procedures will be conducted in accordance with ethical standards and data protection regulations, with samples and clinical data pseudonymized and handled in compliance with the GDPR.",[134,30,135],"Colo-rectal Cancer","Colon Cancer","NOT_YET_RECRUITING","2026-08-04",{"date":139,"type":49},"2026-08-06",{"date":85,"type":22},{"date":142,"type":22},"2029-12-31",{"name":144,"class":56},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":18,"minAge":152,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":67,"phases":155,"briefSummary":156,"conditions":157,"keywords":160,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":90},"100432565","phase-2-neoantigen-dendritic-cell-vaccine-and-nivolumab-in-hcc-and-liver-metastases-from-crc-100432565","NCT04912765","Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC","An Open Label, Single-arm, Phase II Neoantigen (NA) Dendritic Cell (DC) Vaccine and Anti-PD1 (Nivolumab) as Adjuvant Treatment in Resected Hepatocellular Carcinoma (HCC) (Group A) and Liver Metastases From Colorectal Cancer (CRLM) (Group B)","Inclusion Criteria:\n\nHCC specific criteria (Group A):\n\n* Participants must have either newly diagnosed or recurrent HCC, confirmed by histology\u002Fcytology or clinically by AASLD criteria in cirrhotic subjects amenable for management with curative intent by resection (with or without the addition of local ablation), if they fulfil the following radiological criteria.\n\n  1. Up to three tumours, at least one with a diameter \\> 3cm\n  2. More than three tumours, none with a diameter \\> 5 cm\n  3. Recurrent HCCs are permitted if they were previously treated with curative intent (e.g. by surgery or ablative methods) and with liver-limited recurrence fulfilling criteria (a) and (b)\n* Child-Pugh Score 5 or 6\n* All participants are required to have imaging studies (CT chest, tri-phasic CT\u002FMRI of the liver, contrast-enhanced CT\u002FMRI of abdomen and pelvis and other suspected\u002Fknown sites of disease, and bone scans if indicated) confirming no-extra-hepatic metastatic disease within 12 weeks prior to study enrolment.\n\nCRLM specific criteria (Group B):\n\n* Patients with histologically- or cytologically-diagnosed colorectal cancer with liver-limited metastases are eligible to enrol if:\n\n  1. There are no other sites of metastases aside from the liver confirmed by imaging studies (contrast-enhanced CT chest, abdomen and pelvis or contrast-enhanced CT chest and MRI abdomen and pelvis and other suspected sites of disease, and bone scans if indicated) at least 12 weeks prior to study enrolment AND\n  2. The liver metastases are amenable and planned for curative surgical resection with or without the addition of local ablation AND\n  3. The primary colorectal tumour had previously been resected or is amendable and planned for surgical resection.\n* Participants must have received peri-operative chemotherapy or are being planned for adjuvant chemotherapy after curative surgical resection\n* Participants with rectal cancer who received neoadjuvant radiation or are planned for adjuvant radiation are allowed into the study.\n\nGeneral Inclusion Criteria:\n\n* Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC defined as follows:\n\n  1. Non-HBV non-HCV related HCC\n  2. HBV-HCC:\n\n     1. Resolved HBV infection (as evidenced by detectable HBV surface antibody, detectable HBV core antibody, undetectable HBV DNA, and undetectable HBV surface antigen), OR\n     2. Chronic HBV infection as evidenced by detectable HBV surface antigen or HBV DNA. Participants with chronic HBV infection must be on antiviral therapy\n  3. HCV-HCC:\n\n     1. Resolved HCV infection as evidenced by detectable antibody, OR\n     2. Chronic HCV infection as evidenced by detectable HCV RNA.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Screening laboratory values must meet the following criteria, and should be obtained within 28 days prior to study enrolment:\n\n  1. Adequate hematologic function:\n\n     1. WBC ≥ 2,000\u002FμL (stable, off any growth factor within 4 weeks of study treatment administration);\n     2. Neutrophils Absolute ≥ 1,500\u002FμL (stable, off any growth factor within 4 weeks of study treatment administration);\n     3. Hemoglobin ≥ 8.5 g\u002FdL (may be transfused to meet this requirement);\n     4. Platelet count ≥ 60 × 103\u002FμL (transfusion to achieve this level is not permitted);\n  2. Adequate hepatic function:\n\n     1. Serum albumin \\> 2.8 g\u002FL (transfusion to meet this level is not permitted); and\n     2. Serum total bilirubin \\\u003C 3 mg\u002FdL, and\n     3. Serum Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 5 × ULN;\n  3. Prothrombin time (PT)-international normalized ratio (INR) \\\u003C 2.3 or Prothrombin time (PT) \\\u003C 6 seconds (transfusion to achieve this level is not permitted)\n  4. Adequate renal function with a serum creatinine of \\\u003C 1.5 × ULN or a creatinine clearance \\> 40 mL\u002Fmin (Cockcroft-Gault formula)\n* Age and Reproductive Status:\n\n  1. Males and females, ages 21 or older.\n  2. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.\n  3. Women must not be breastfeeding.\n  4. WOCBP must agree to follow instructions for method(s) of contraception (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of study treatment with nivolumab and 7 months after the last dose of study treatment.\n  5. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of study treatment with nivolumab and 7 months after the last dose of study treatment. In addition, male participants must be willing to refrain from sperm donation during this time.\n  6. Azoospermic males are exempt from contraceptive requirements. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, and still must undergo pregnancy testing as described in this section.\n\nExclusion Criteria:\n\nHCC specific criteria (Group A):\n\n* Target Disease Exceptions\n\n  1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n  2. Any evidence of tumour metastasis or co-existing malignant disease.\n  3. Participants showing evidence of macrovascular invasion on imaging tests.\n  4. Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation.\n  5. Participants previously receiving any prior systemic therapy, trans-arterial embolization or chemoembolisation (TAE\u002FTACE), selective internal radiation therapy (SIRT) and stereotactic radiation therapy (SBRT) for HCC.\n\n     CRLM specific criteria (Group B)\n* Target Disease Exceptions a) Patients with extra-hepatic colorectal metastases.\n\nGeneral Inclusion Criteria:\n\n* Medical Conditions\n\n  1. Active co-infection with:\n\n     1. Both hepatitis B and C as evidenced by detectable HBV surface antigen (HBs Ag) or HBV DNA and HCV RNA, OR\n     2. Hepatitis D infection in participants with hepatitis B\n  2. Known positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n  3. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the participant to receive protocol therapy, or interfere with the interpretation of study results.\n  4. Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n  5. Participants with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n  6. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n* Prior\u002FConcomitant Therapy\n\n  1. Participants receiving or expected to receive IFN-based therapies during the study period.\n  2. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n  3. Treatment with botanical preparations (e.g., herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to start of therapy.\n* Physical and Laboratory Test Findings\n\n  a. Positive pregnancy test\n* Allergies and Adverse Drug Reaction\n\n  1. History of severe hypersensitivity to a monoclonal antibody.\n  2. History of allergy or hypersensitivity to study drug components\n* Other Exclusion Criteria\n\n  1. Prisoners or participants who are involuntarily incarcerated.\n  2. Participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.","21 Years",{"count":154,"type":22},60,[70],"This is a single arm phase II study of adjuvant intra-dermal NA DC vaccine combined with intravenous nivolumab in patients with resectable HCC (group A) or CRLM (group B) planned for curative surgery (with\u002Fwithout local ablation).",[106,107,158,159,30],"Colorectal Cancer","Colorectal Carcinoma",[161,162,163,158,107,164,165],"Tumour neoantigens","Tumor neoantigens","Cancer vaccine","Immunotherapy","anti-PD1","2026-07-30",{"date":168,"type":49},"2026-07-31",{"date":170,"type":49},"2021-04-15",{"date":172,"type":22},"2027-06",{"name":174,"class":56},"National Cancer Centre, Singapore",{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":67,"phases":184,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":90},"100614617","phase-1-hepzato-kit-and-opdualag-for-metastatic-melanoma-and-liver-metastasis-100614617","NCT07281924","Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis","A Phase 1b\u002F2 Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of Melphalan Percutaneous Hepatic Perfusion Therapy (HEPZATO KIT™) With Nivolumab and Relatlimab (Opdualag) in Patients With Metastatic Melanoma and Liver Metastasis","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic melanoma with liver metastasis (LM). Liver biopsy positive for presence of melanoma metastases is required.\n* 0-1 line of prior systemic therapy in the unresectable\u002Fmetastatic setting - prior adjuvant anti-programmed cell death-1 (anti-PD-1) or BRAF\u002FMEK targeted therapy is considered 1 line of prior systemic therapy if less than 6 months from the last treatment.\n* Evaluable\u002Fmeasurable disease according to RECIST v1.1.\n* Demonstrate adequate organ function; all screening labs to be obtained within 28 days prior to registration.\n* Patients must weigh greater than or equal to 35 kilograms (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System).\n\nExclusion Criteria:\n\n* Prior treatment with HEPZATO KIT™ or nivolumab and relatlimab (Opdualag™)\n* Radiotherapy is permitted within 30 days prior to C1D1 as long as radiation is given with palliative intent and towards a non-target lesion.\n* History of hypersensitivity or treatment discontinuation due to grade 3+ immune-related adverse events (irAEs) from prior anti-PD-(L)1 therapy. Patients who are able to successfully resume immune checkpoint therapy without recurrence of grade 3 irAEs are eligible to participate.\n* Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation.\n* Prednisone use greater than or equal to 10 mg\u002Fd or equivalent\n* Organ transplant recipients",{"count":183,"type":22},15,[69,70],"This study is being done to see if combining HEPZATO KIT™ with nivolumab and relatlimab (Opdualag™) in patients with metastatic melanoma with liver metastasis is safe, tolerable, and will have a synergistic effect leading to improved clinical outcomes compared to the historic cohort of patients with liver metastasis treated with combination immune checkpoint inhibitor therapy.",[187,30],"Metastatic Melanoma",[189,76,190,191,192,193,194,195,196,197,198,199],"immunotherapy","Anti-PD-1","Anti-LAG-3","Melphalan","Percutaneous Hepatic Perfusion Therapy","Liver directed therapy","Nivolumab","Relatlimab","Immune Checkpoint Inhibitors","Hepzato","Opdualag","2026-07-27",{"date":202,"type":49},"2026-07-29",{"date":204,"type":22},"2026-08",{"date":206,"type":22},"2030-12",{"name":208,"class":56},"University of Wisconsin, Madison",{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":215,"targetDuration":217,"studyType":23,"phases":4,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100648032","dragon-registry---international-multicenter-registry-and-medical-image-bank-for-patients-with-primarily-unresectable-liver-cancer-or-liver-metastases-that-underwent-combined-portal-and-hepatic-vein-embolization-pvehve-to-increase-future-liver-remnant-before-resection-100648032","NCT07717437","DRAGON Registry - International Multicenter Registry and Medical Image Bank for Patients With Primarily Unresectable Liver Cancer or Liver Metastases That Underwent Combined Portal and Hepatic Vein Embolization (PVE\u002FHVE) to Increase Future Liver Remnant Before Resection.","Inclusion Criteria:\n\n* Patients who have undergone PVE\u002FHVE or technical variations on this procedure\n* 18 Years and older\n* Men and women",{"count":216,"type":22},350,"5 Years","The DRAGON registry aims to collect data on combined portal and hepatic vein embolization (PVE\u002FHVE) for liver tumors, a technique expected to enhance liver regeneration compared to standard PVE. This collaborative registry focuses on identifying associations between baseline clinical\u002Fimaging parameters, clinical outcomes, and safety for patients undergoing PVE\u002FHVE.",[105,30],[221,76,222,223,224,225,226,227,228,229,230,231,232,233,234,235,106,236,237],"Liver cancer","Portal vein embolization","PVE","HVE","PVE\u002FHVE","Future liver remnant","Liver resection","Hepatectomy","Post-hepatectomy liver failure","Surgical oncology","Double Vein Embolisation","FLR","Liver Venous Deprivation","LVD","Hepatic Vein Embolization","Perihilar cholangiocarcinoma","Intrahepatic cholangiocarcinoma","2026-07-16",{"date":240,"type":49},"2026-07-21",{"date":242,"type":49},"2021-03-16",{"date":244,"type":22},"2032-11-30",{"name":246,"class":56},"Maastricht University Medical Center",31,{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":67,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":90},"100444045","phase-2-ctdna-directed-post-hepatectomy-chemotherapy-for-patients-with-resectable-colorectal-liver-metastases-100444045","NCT05062317","ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases","Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases","Inclusion Criteria:\n\n* Patients ≥18 years of age with CLM undergoing elective hepatectomy with curative intent (primary colorectal primary cancer previously removed OR being removed at time of hepatectomy) after preoperative chemotherapy (i.e., FOLFOX\u002FFOLFIRI +\u002F- bevacizumab or panitumumab\u002Fcetuximab) from 07\u002F01\u002F2021 - 12\u002F31\u002F2023\n* Must receive ≥ 4 cycles of preoperative chemotherapy\n\nExclusion Criteria:\n\n* Patients with primary colorectal tumor that will remain in situ\n* Inability to undergo postoperative chemotherapy, or postoperative chemotherapy not planned a priori\n* Unwilling\u002Funable to undergo blood draws for ctDNA, patient or provider-determined\n* Other active malignancies requiring treatment\n* Women who are pregnant",{"count":256,"type":22},120,[70],"To determine if the detection of ctDNA after surgical resection of CLM can stratify patients into high and low-risk cohorts for early disease recurrence in order to inform post-operative adjuvant therapy.",[30],"2026-07-13",{"date":262,"type":49},"2026-07-14",{"date":264,"type":49},"2022-04-26",{"date":266,"type":22},"2027-02-28",{"name":268,"class":56},"M.D. Anderson Cancer Center",{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":67,"phases":279,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":90},"100577114","phase-3-sbrt--pd-1-monoclonal-antibody-in-unresectable-colorectal-liver-metastases-100577114","NCT06794086","SBRT + PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases","SBRT Combined With PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases: A Prospective, Multicenter, Single-arm, Phase II Clinical Study (SPARKLE-L)","SPARKLE-L","Inclusion Criteria:\n\n1. Written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulatory and institutional guidelines before any procedures related to the study protocol that are not part of routine care are performed.\n2. Patients with pMMR\u002FMSS colorectal adenocarcinoma;\n3. Age 18-75 years;\n4. Patients with histologically or cytologically confirmed colorectal cancer liver metastasis, with or without extrahepatic oligometastatic lesions, who are deemed by the hepatobiliary surgeon within the multidisciplinary team (MDT) to be ineligible for upfront R0 resection of liver metastases (unresectability is defined as one or more of the following conditions: ① Involvement of both left and right branches of the portal vein at the first hepatic hilum; ② Involvement of ≥2 hepatic veins at the second hepatic hilum; ③ No indication for upfront R0 resection\u002Fablation after MDT discussion);\n5. Liver metastases are measurable by imaging (based on RECIST 1.1 criteria), with a maximum diameter of ≤6 cm;\n6. Patients who have not previously received radiotherapy for liver metastases, or whose liver tissue near the planned irradiation site has not been previously irradiated, and who have at least 700 cc of liver volume outside the treatment area;\n7. Previous hepatectomy, systemic chemotherapy, or local ablation therapy, or hepatic arterial infusion pump chemotherapy is allowed, with a washout period of 2 weeks;\n8. Child-Pugh score Class A ;\n9. ECOG performance status 0-1;\n10. Peripheral blood counts and liver and renal function within allowable ranges (tested within 15 days before the start of treatment);\n11. No history of other malignancies, not pregnant or breastfeeding, and effective contraception should be used during the study period and for 6 months after the last dose;\n12. Life expectancy of ≥6 months.\n\nExclusion Criteria:\n\n1. Active hepatitis, cirrhosis, or Child-Pugh score Class B or C;\n2. Extrahepatic metastases: bone or brain metastases, or ≥3 unresectable lung metastases (according to the 8th edition of the UICC);\n3. Unmeasurable liver metastases;\n4. History of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);\n5. Patients who have participated in or are currently participating in other clinical trials within the past 4 weeks;\n6. History of prior treatment with anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapies;\n7. Severe electrolyte abnormalities;\n8. Presence of gastrointestinal diseases, such as active gastric or duodenal ulcers, ulcerative colitis, or unresected tumors with active bleeding; or other conditions that may lead to gastrointestinal bleeding or perforation (Note: Gastrointestinal fistulas that have not healed after surgical treatment, such as rectovesical, rectourethral, or rectovaginal fistulas, are exclusionary unless a stoma has been created and there are no active symptoms);\n9. History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months;\n10. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants unwilling to strictly practice contraception during the study, as well as their partners;\n11. Patients with active autoimmune deficiency diseases requiring systemic treatment within the past 2 years (i.e., use of immunomodulators, corticosteroids, or immunosuppressive drugs);\n12. Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for over 3 years, or in situ cancers that can be cured with adequate treatment);\n13. Presence of severe ECG abnormalities or active coronary artery disease within 12 months before study entry, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction, or New York Heart Association (NYHA) Class II or higher congestive heart failure;\n14. Patients with active infections (fever above 38°C due to infection);\n15. Patients with poorly controlled hypercalcemia, hypertension, or diabetes;\n16. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n17. Patients with psychiatric disorders affecting clinical management or a history of central nervous system diseases;\n18. Patients with severe complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);\n19. Presence of any CTCAE Grade 2 or higher toxicity from prior treatments that has not resolved (except for anemia, alopecia, and skin pigmentation);\n20. Any unstable medical condition that may affect patient safety or compliance with the study;\n21. Patients deemed by the investigator to be unsuitable for participation in this clinical trial.","75 Years",{"count":66,"type":22},[280],"PHASE3","To explore the efficacy and safety of stereotactic body radiation therapy (SBRT) combined with PD-1 monoclonal antibody in the treatment of unresectable colorectal cancer liver metastasis through a prospective study, providing high-level evidence-based medical evidence for the use of SBRT combined with PD-1 inhibitors in the treatment of unresectable colorectal cancer liver metastasis.",[158,30],[284,285],"Stereotactic body radiation therapy","PD-1 Monoclonal Antibody","2026-06-29",{"date":288,"type":49},"2026-06-30",{"date":290,"type":49},"2025-04-10",{"date":292,"type":22},"2027-01-20",{"name":294,"class":56},"Jun Huang",{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":304,"conditions":305,"keywords":310,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":322},"100538199","french-assessment-of-mrd-by-liquid-biopsies-in-colorectal-with-liver-metastasis-patients-frenchmrdcrlm-100538199","NCT06287723","French Assessment of MRD by Liquid Biopsies in Colorectal With Liver Metastasis Patients (FRENCH.MRD.CRLM)","French Assessment of Minimal Residual Disease by Liquid Biopsies in Colorectal With Liver Metastasis Patients","Inclusion Criteria:\n\n* Patient 18 years or older.\n* Colorectal cancer liver metastasis or metastases, according to the assessment of the MDT.\n* Metachronous and synchronous metastases will be included, as long as treatment intention of metastases resection is curative. In case of rare instances, where the liver metastases is removed before surgery of the primary tumor, postOP ctDNA is collected when the patient is considered completely tumor-free, i.e. after complete surgery of both the liver metastases and the primary tumor.\n* Treatment is planned with curative intent (patients treated with RFA can be included, BUT in these cases a tissue sample from the primary CRC tumor is a requisite)\n\nExclusion Criteria:\n\n* Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome.\n* Extrahepatic metastases\n* Malignant colorectal polyps diagnosed after polypectomy.\n* Synchronous colorectal and non-colorectal cancer diagnosed per operative (except skin cancer other than melanoma)\n* Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from eligibility screening\n* Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and\u002For otherwise considered by the Investigator to be unlikely to complete the study.\n* Liver cirrhosis\n* CRLM intervention\u002Fsurgery cannot be\u002Fwas not performed with curative intent\n* No tumor tissue available (preferably CRLM lesion, or alternatively primary tumor)\n* Pregnant or nursing woman, or in childbearing age and not willing to use contraception\n* Protected and vulnerable adult\n* Not covered by Health insurance\n* Patient unable to understand and sign written informed consent.",{"count":303,"type":22},30,"Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough.\n\nThere is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points.\n\nThe GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient.\n\nFRENCH.MRD.CRLM is the French study and part of the european GUIDE.MRD project.",[158,30,306,307,308,309],"Stage IV Colorectal Cancer","Minimal Residual Disease","Liquid Biopsy","ctDNA",[311,307,312],"Stage IV colorectal cancer","Liquid biopsy","2026-06-17",{"date":315,"type":49},"2026-06-22",{"date":317,"type":49},"2024-04-15",{"date":319,"type":22},"2029-04-15",{"name":321,"class":56},"University Hospital, Montpellier",2,{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":67,"phases":332,"briefSummary":333,"conditions":334,"keywords":335,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":90},"100502979","alpha-radiation-emitters-device-dart-for-the-treatment-of-liver-metastases-100502979","NCT05829291","Alpha Radiation Emitters Device (DaRT) for the Treatment of Liver Metastases","A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Liver Metastases","Inclusion Criteria:\n\n1. Referred for a two staged hepatectomy following a multidisciplinary team discussion, to resect liver metastases of colorectal cancer\n2. Targetable lesion(s) must be technically amenable for complete coverage (including margins) by the Alpha DaRT Seeds \u002F Target(s) must be reachable for implantation\n3. Liver lesions are visible and measurable by CT according to RECIST v 1.1\n4. Age ≥ 18 years old\n5. ECOG Performance Status Scale ≤ 2\n6. Subjects' life expectancy is at least 12 weeks\n7. The following laboratory parameters\n\n   * WBC ≥ 3500\u002Fµl, granulocyte ≥ 1500\u002Fµl\n   * Hemoglobin \\> 85 g\u002FL\n   * Total bilirubin \\\u003C 51.3 umol\u002FL\n   * Platelet count \\>75 X 109 \u002FL or \\> 50% Prothrombin activity\n   * Amylase and lipase \\\u003C 1.5 X the upper limit of normal\n   * AST and ALT ≤ 5 X ULN\n   * Prothrombin time (PT) international normalized ratio (INR) \\\u003C 2.3 or PT \\\u003C 6 seconds above control. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists\n8. Subjects are willing and able to sign an informed consent form\n9. Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test within seven days before the Ra-224 implantation\n10. Subjects must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy\n\nExclusion Criteria:\n\n1. Concurrent cancer that is distinct in primary site or histology from colorectal cancer. Except cervical carcinoma in situ, prostate cancer with good prognosis, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \\& T1). Any cancer curatively treated 3 years prior to entry is permitted.\n2. Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids\n3. Contraindication to angiography:\n\n   * Any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agent\n   * Severe peripheral vascular disease precluding catheterization\n   * History of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically\n4. Known hypersensitivity to any of the components of the treatment.\n5. Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n6. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.\n7. Brain metastases\n8. Active clinically serious infections\n9. Major surgery within 4 weeks of start of the study therapy\n10. Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n11. Any condition that is unstable or which could jeopardize the safety of the patient and his\u002Fher compliance in the study\n12. High probability of protocol non-compliance (in opinion of investigator)\n13. Pregnant or breastfeeding women\n14. Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT\n\n    \\-",{"count":331,"type":22},10,[102],"This is a single center study enrolling up to 10 patients. The primary objective is to Evaluate the feasibility and safety of the DaRT for the treatment of Liver Metastases. The secondary objective is to evaluate the pathological response of liver metastases according to the Modified tumor regression grade\\[1\\] and to evaluate the radiological response of liver metastases using the RECIST criteria.",[30],[336,337,30,338],"Alpha radiation","Alpha emitting radiation","Brachytherapy","2026-06-15",{"date":341,"type":49},"2026-06-16",{"date":343,"type":49},"2023-10-01",{"date":345,"type":22},"2027-07",{"name":347,"class":348},"Alpha Tau Medical LTD.","INDUSTRY",{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":67,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":90},"100364058","oar-based-dose-escalated-sbrt-with-real-time-adaptive-mri-guidance-for-liver-metastases-100364058","NCT04020276","OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases","A Phase I Study of OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases","Inclusion Criteria:\n\n* Have a diagnosis of histologically confirmed or clinically suspected metastatic cancer to the liver.\n* Participant must be a candidate for SBRT to at least one intrahepatic lesion but no more than 6 intrahepatic lesions.\n* Participant must be a candidate for treatment on the ViewRay treatment unit. Must be screened to rule out implants and devices that are not MRI compatible.\n* Be willing and able to provide written informed consent.\n* Participants may be therapy-naïve or have had prior systemic therapy up to two weeks prior to study entry.\n* No active central nervous system (CNS) metastatic disease. NOTE: Subjects with CNS involvement must meet all of the following to be eligible:\n\n  * At least 28 days from prior definitive treatment of their CNS disease by surgical resection, SBRT or Whole Brain Radiation Therapy (WBRT) at the time of registration\n  * AND asymptomatic and off systemic corticosteroids and\u002For enzyme-inducing antiepileptic medications for brain metastases for \\>14 days prior to registration.\n* Demonstrate adequate organ function as defined in the following table; all screening labs should be performed within 28 days of SBRT treatment initiation.\n\n  * Platelet count greater than or equal to 50000 \u002FµL\n  * Absolute Neutrophil Count (ANC) greater than or equal to 1000 \u002FµL\n  * Hemoglobin (Hgb) greater than or equal to 8 g\u002FdL or greater than or equal to 5.6 mmol\u002FL without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)\n  * Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) Creatinine\u002FCalculated creatinine clearance (CrCl) greater than or equal to 30 mL\u002Fmin for subject with creatinine levels greater than 1.5 X institutional upper limit of normal (ULN)\n  * Bilirubin greater than or equal to 1. 5 × ULN OR direct bilirubin greater than or equal to ULN for participants with total bilirubin levels greater than 1.5 ULN\n  * Aspartate aminotransferase (AST) and ALT (SGPT) greater than or equal to 5 × ULN\n  * International Normalized Ratio (INR) or Prothrombin Time (PT) greater than or equal to 1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n  * Activated Partial Thromboplastin Time (aPTT) greater than or equal to 1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n* For participants enrolled on the liver dose escalation arm, screening labs must be consistent with Child Pugh class A unless therapeutic anticoagulation places them in Child Pugh B. In that case, trial entry or exclusion will be at the discretion of the treating physician.\n* Have a performance status of 2 or less on the Eastern Cooperative Oncology Group (ECOG) performance scale.\n* Life expectancy of \\> 12 weeks.\n* Women of childbearing potential (WOCP) should have a negative urine or serum pregnancy test prior to initiation of radiation therapy. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* WOCP must not be pregnant or breast-feeding.\n* WOCP must be willing to use an effective method of birth control such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence for the duration of the radiotherapy and 60 days thereafter.\n\nNOTE: A person of childbearing potential is anyone (regardless of sexual orientation, gender identity, having undergone a tubal ligation, or remaining celibate by choice) who was born with a uterus and at least one ovary and meets both of the following criteria:\n\n* Is post-menarcheal (i.e., has had at least one prior menses)\n* Has not undergone a hysterectomy or bilateral oophorectomy or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n* Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the initiation of SBRT.\n* History of a second invasive cancer in the last 3 years (except for appropriately treated low-risk prostate cancer, treated non-melanoma skin cancer, appropriately treated ductal carcinoma in situ or early stage invasive carcinoma of breast appropriately treated in situ\u002Fearly stage cervical\u002Fendometrial cancer.\n* Has an active infection requiring systemic therapy.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with follow up scans or visits.\n* Has a primary tumor histology of germ cell tumor, leukemia, or lymphoma.\n* Has a primary liver cancer such as cholangiocarcinoma or hepatocellular carcinoma.\n* Has had prior radiation therapy that significantly overlaps with the liver.\n* Has a diagnosis of Crohn's disease, ulcerative colitis, or scleroderma.\n* Participants with Gilbert's disease or other primary disorders of bilirubin metabolism will not be allowed on the trial.\n* For participants in the liver dose escalation arm only, has pre-existing liver disease such that patients are classified as Child Pugh B or worse. If the participant is anti-coagulated such that their INR places them in the CP-B classification, exclusion or inclusion will be at the discretion of the treating physician.\n* Pregnancy or women of childbearing potential and men who are sexually active and refuse to use medically acceptable forms of contraception.\n* Participants with implanted hardware that would preclude MRIs.",{"count":357,"type":22},32,[102],"The purpose of this trial is to identify a safe maximum tolerated dose level for MRI-guided Stereotactic Body Radiation Therapy (SBRT) treatment of bowel and liver metastases, respectively.\n\nEligible participants will be on study for up to 12 months.",[30,361,362],"Stereotactic Body Radiation Therapy","MRI-guided Treatment","2026-06-09",{"date":365,"type":49},"2026-06-11",{"date":367,"type":49},"2019-11-04",{"date":369,"type":22},"2028-12",{"name":208,"class":56},{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":67,"phases":380,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":90},"100186044","proton-therapy-in-the-treatment-of-liver-metastases-100186044","NCT01697371","Proton Therapy in the Treatment of Liver Metastases","Phase I-II Trial of Stereotactic Body Proton Therapy for Patients With Liver Metastases","Inclusion Criteria:\n\nPathologically confirmed non-lymphoma liver metastases or\n\nNew radiographic liver lesions consistent with metastases in patients with known pathologically confirmed non-lymphoma cancer\n\n1-3 liver lesions measurable on CT\u002FMRI or PET\u002FCT performed within 6 weeks prior to study entry\n\nLiver metastases measuring \\\u003C5cm\n\nLife expectancy \\>6 months\n\nDisease outside the liver is allowed\n\nAge ≥ 18\n\nECOG Performance Scale = 0-1\n\nAdequate bone marrow function, defined as follows:\n\n* Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3 based upon CBC\u002Fdifferential obtained within 4 weeks prior to registration on study\n* Platelets ≥ 60,000 cell\u002Fmm3 based upon CBC\u002Fdifferential obtained within 4 weeks prior to registration on study\n* Hemoglobin ≥ 8.0 g\u002Fdl based upon CBC\u002Fdifferential obtained within 4 weeks prior to registration on study (Note: the use of transfusion or other intervention to achieve Hgb ≥ 8.0 is acceptable.)\n\nAdequate kidney function (serum creatinine \\\u003C2mg\u002FdL) based on chemistry panel obtained within 4 weeks prior to registration on study\n\nAdequate liver function, defined as total bilirubin \\\u003C5 mg\u002FdL, serum albumin \\>2.0g\u002FdL, serum levels of liver enzymes \\\u003C 5 times the upper limit of normal, and INR \\\u003C 1.5\n\nPrevious liver resection or ablative therapy is permitted\n\nChemotherapy and\u002For targeted agent therapy must be completed at least 2 weeks prior to radiation and started at least 14 days after completion of SBPT Women of childbearing potential and male participants must practice adequate contraception\n\nPatient must sign study specific informed consent prior to study entry\n\nPretreatment evaluations required for eligibility include:\n\n* A complete history and general physical examination\n* For women of childbearing potential, a serum or urine pregnancy test must be performed within 72 hours prior to registration\n* INR, total bilirubin, albumin, alkaline phosphatase, ALT, AST within 4 weeks prior to study entry\n\nExclusion Criteria:\n\nPrior invasive malignancy other than liver met primary (except non-melanomatous skin cancer) unless disease free for \\> 3years\n\nPrior radiotherapy that would results in overlap of radiation fields\n\nPrior radiotherapy to the liver\n\nSevere, active co-morbidity that may impact survival\n\nCNS metastases\n\nTense ascites requiring frequent paracentesis\n\nActive liver infection\n\nPregnancy, nursing women, or women of child bearing potential, and men who are sexually active and not willing\u002Fable to use medically acceptable forms of contraception\n\nMetastases location within 2cm of GI tract\n\n\\-",{"count":379,"type":22},35,[102],"Local control of hepatic metastases appears to be a major determinant of overall survival. However, many patients are not suitable for resection due to medical or surgical reasons. Therefore, there is an important role for a treatment that can provide the equivalent of tumor resection with minimal morbidity. Stereotactic body radiotherapy (SBRT) delivers an ablative regimen of highly focused external beam radiotherapy that targets one or more discrete extracranial lesions. Published reports using SBRT to treat liver metastases have shown actuarial local control rates ranging from 50-100% with higher doses associated with better local control.\n\nIn patients with metastatic liver disease, aggressive local therapy using modern radiotherapy techniques are promising and project to have a substantial role in the treatment of metastatic liver cancer to treat unresectable disease. The dosimetric advantage of proton therapy may lead to improved clinical outcomes with less morbidity, however, there is no clinical data to confirm this assertion. We thus propose a phase I study to determine the feasibility and safety of stereotactic body proton therapy in patients with liver metastases followed by a phase II study to determine the efficacy of such treatment on local control.",[30],"2026-06-03",{"date":385,"type":49},"2026-06-05",{"date":387,"type":49},"2012-08-22",{"date":389,"type":22},"2033-09",{"name":391,"class":56},"Loma Linda University",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":399,"enrollmentInfo":400,"targetDuration":4,"studyType":67,"phases":401,"briefSummary":402,"conditions":403,"keywords":405,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":90},"100469866","liver-transplantation-for-non-resectable-colorectal-liver-metastases-translational-research-100469866","NCT05398380","Liver Transplantation for Non-resectable Colorectal Liver Metastases: Translational Research","Clinical Impact of Molecular Biomarkers in Liver Transplantation for Non-resectable Colorectal Liver Metastases: Translational Research","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Male or female, aged 18-70 years old inclusive at study entry.\n3. ECOG (Eastern Cooperative Oncology Group) 0 or 1.\n4. Histologically-proven primary colorectal tumor.\n5. Bilateral, limited at liver and non-resectable CRLM by consensus in Multidisciplinary Committee.\n6. Resection of primary colorectal tumor according oncological principles and adequate TNM stage.\n7. Time from primary colorectal tumor resection to transplant ≥ 12 months.\n8. Primary colorectal tumor stage ≤ T3N1. If time between primary tumor resection is ≥ 2 years, stage T4N0 or T4N2 is accepted.\n9. No signs of extrahepatic metastatic disease according to PET\u002FCT scan, CT and pelvic MRI.\n10. The patient has undergone systemic chemotherapy for a minimum of 3 months at the time of screening and maximum of 2 lines of fluoropyrimidine based chemotherapy combined or not with irinotecan or oxaliplatin associated or no not with targeted therapy based in molecular biomarkers.\n11. Demonstrated stability or partial regression of CRLM following RECIST criteria v 1.1., at minimum 3 months since the last treatment received and immediately prior to screening.\n12. CEA (Carcinoembryonic antigen) values ≤ 80 µg\u002FL immediately prior to screening.\n13. Adequate blood test regarding:\n\n    * Creatinine ≤1.25 x upper normal level or estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73m2 using following the Chronic Kidney disease epidemiology collaboration (CKD-EPI) formula.\n    * Platelets ≥80 × 109\u002FL\n    * Neutrophiles ≥ 2.5 × 109\u002FL\n14. Patients with hepatic failure after resection will be considered if it occurs as a consequence of an inadequate preoperative estimation of the functional volume that would have contraindicated the surgery. They should meet the inclusion criteria and none of the exclusion criteria.\n\nExclusion Criteria:\n\n1. Largest Lesion \\>5.5cm immediately prior to screening\n2. Patients with Lynch Syndrome\n3. BRAF mutation and\u002For primary tumor of microsatellite instability (MSI)\n4. Recurrence of primary tumor confirmed by colonoscopy or pelvic MRI within the last 12 months prior to screening.\n5. Previous or concurrent cancer in the last 5 years. Any cancer curatively treated 5 years prior to entry or treated basal cell carcinoma is permitted.\n6. Substance abuse, medical, psychological or social conditions that may interfere with the patient´s participation in the study or evaluation of the study results.\n7. Cardiac or pulmonary disease uncontrolled as contraindication for any surgical procedure.\n8. Active infection.\n9. Pregnant or breast-feeding patients\n10. Any reason why in the opinion of the investigator, the patient should not participate.","70 Years",{"count":379,"type":22},[102],"The patients with non-resectable colorectal liver metastases (CRLM) have always being considered a particular subgroup of CRLM in which the therapeutic approach, is focused on strategies that allow a potential surgery like neoadjuvant systemic treatments. But, the underlying biology that causes this particular profile of spread in a proportion of patients that always recur and progress in the liver has not been properly characterized from a biological point of view. Unfortunately, these patients finally develop liver metastasis not amenable for local treatments and become refractory to systemic treatments even without developing extrahepatic liver metastases. As a result, liver transplantation (LT) is a potential for patients without extrahepatic involvement and nonresectable CRLM. There are several studies that aims to evaluate if LT increases overall survival compared to best alternative care. To our knowledge, none of these studies incorporate objectives focused on the underlying tumor biology of this particular population and the development of focused strategies including a dynamic disease monitoring and targeted treatments for this particular population.The METLIVER trial will permit to expand the genetic studies to the whole complexity of metastatic lesions and a more precise evaluation of their genetic heterogeneity. Moreover, it will help to precise the type of genetic analyses on liquid biopsies that can be designed for patients that will unfortunately relapse mostly with lung metastases after LT. Our proposal will maximize the opportunity to produce an unprecedented knowledge on CRLM evolution and will provide new opportunities for relapsed patients.",[158,30,404],"Genetic Change",[406,407,408,409],"Liver Transplantation","Non-resectable colorectal liver metastases","Tumoral biomarkers","Translational research","2026-05-21",{"date":412,"type":49},"2026-05-22",{"date":414,"type":49},"2022-01-01",{"date":416,"type":22},"2026-12-31",{"name":418,"class":56},"Hospital Vall d'Hebron",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":425,"enrollmentInfo":426,"targetDuration":428,"studyType":23,"phases":4,"briefSummary":429,"conditions":430,"keywords":435,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":57},"100637253","china-metastatic-liver-cancer-clinical-registry-cohort-database-100637253","NCT07602504","China Metastatic Liver Cancer Clinical Registry Cohort Database","Inclusion Criteria:\n\n1. Patients with histologically or radiologically confirmed metastatic liver cancer.\n2. Age ≥ 18 years.\n3. Patients who have voluntarily signed the informed consent form.\n4. Patients with complete baseline clinical data.\n\nExclusion Criteria:\n\n1. Patients with primary liver cancer (e.g., hepatocellular carcinoma).\n2. Patients with other malignant tumors that may interfere with the evaluation of liver metastasis.\n3. Patients who have previously participated in other interventional clinical trials.\n4. Patients with severe cognitive disorders or communication barriers that prevent informed consent.\n5. Patients with incomplete or missing key clinical data.","80 Years",{"count":427,"type":22},2000,"10 Years","This study is led by the Department of Hepatobiliary Surgery of the First Affiliated Hospital of the University of Science and Technology of China (USTC), in close collaboration with multiple participating centers nationwide. The primary objective is to establish a standardized, large-scale clinical cohort database specifically for metastatic liver cancer. By collecting comprehensive data on patient demographics, primary tumor characteristics, systemic therapies, and local interventions, this registry aims to elucidate the clinical patterns and prognostic factors of secondary liver malignancies. This database will serve as a robust platform for conducting high-quality real-world studies and advancing evidence-based clinical research in the management of metastatic liver cancer.",[30,431,105,432,433,434],"Metastases to Liver","Neoplasms","Liver Diseases","Colorectal Cancer Metastatic",[436],"Liver Metastases; Metastatic Colorectal Cancer","2026-05-16",{"date":412,"type":49},{"date":440,"type":22},"2026-06-01",{"date":442,"type":22},"2036-05-31",{"name":444,"class":445},"Anhui Provincial Hospital","OTHER_GOV",{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":67,"phases":453,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":90},"100539178","phase-2-platform-study-of-immunotherapy-combinations-in-colorectal-cancer-liver-metastases-100539178","NCT06300463","Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases","Inclusion Criteria:\n\n* Diagnosis of metastatic colorectal adenocarcinoma with liver metastases\n* Participant must be planning to undergo a surgical resection of their liver metastases.\n* Tumor is non-MSI-H\u002FdMMR\n* Presence of measurable disease\n* Participants must be willing to consent to additional molecular analyses of tumor samples removed during surgery for research purposes\n* Women of childbearing potential (WOCBP), or anyone with a uterus, must not be pregnant or breastfeeding. All participants of childbearing potential must agree to use highly effective contraception during this study\n* Participants may not receive chemotherapy, growth factor support, transfusions, or albumin administration within 14 days of start of study treatment.\n\nExclusion Criteria:\n\n* Not eligible for surgery\n* Any medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.\n* Previous allogeneic tissue\u002Forgan transplant\n* Previously received PD-1, PD-L1, or CTLA-4 therapy including experimental immunologic agents\n* Participants must not have any contraindications to immune checkpoint inhibitors\n* Participants must not have active autoimmune disease that has required systemic treatment within 2 years prior to registration. Some exceptions are allowed",{"count":66,"type":22},[70],"The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The main questions it aims to answer are:\n\n* whether these combinations of immunotherapy change the tumor microenvironment in the liver\n* whether these combinations of immunotherapy are safe and effective when used in colorectal cancer with liver metastases\n\nParticipants will be randomly assigned to one of the following:\n\n* Botensilimab and balstilimab\n* Botensilimab, balstilimab, and AGEN1423\n* Botensilimab, balstilimab, and radiation\n\nParticipants will be asked to come in to receive drug infusions (and radiation, if applicable) before and after their surgical resection. Participants will be followed for up to 2 years.",[434,30,158],[457,458,164],"Botensilimab","Balstilimab","2026-05-13",{"date":461,"type":49},"2026-05-15",{"date":463,"type":49},"2024-03-26",{"date":465,"type":22},"2027-12",{"name":467,"class":56},"Weill Medical College of Cornell University",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":67,"phases":476,"briefSummary":477,"conditions":478,"keywords":484,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":322},"100535953","phase-2-same-in-prevention-of-oxaliplatin-associated-liver-injury-100535953","NCT06258525","SAMe in Prevention of Oxaliplatin-associated Liver Injury","A Phase II, Open-Label Trial of S-Adenosylmethionine (SAMe) in Prevention of Oxaliplatin Associated Liver Injury","Inclusion Criteria:\n\n* Stage IV patients with resectable liver predominant metastatic colorectal cancer (new diagnosis or recurrent) referred to Cedars Sinai Medical Center for oxaliplatin based systemic therapy.\n* Age ≥ 18 years.\n* Patients who are planning to undergo liver resection following oxaliplatin based chemotherapy treatment.\n* ECOG Performance Status 0-2 or Karnofsky Performance Status (KPS) ≥ 60%.\n* Demonstrate adequate organ and marrow function (within 28 days of study treatment initiation)\n* Female subjects of childbearing potential should have a negative urine or serum pregnancy within 14 days prior to receiving the first dose of study medication for eligibility verification purposes. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Female subjects of childbearing potential should be willing to use adequate methods of birth control (hormonal or barrier method of birth control) or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\>1 year.\n* Male subjects should agree to use an adequate method of contraception starting with the first dose of therapy through 120 days after the last dose of therapy.\n* Subjects taking vitamin E ≥800 IU\u002Fday must be on a stable dose defined as:\n\n  1. No changes in prescribed dose within 180 days of the screening visit and\n  2. No new vitamin E-containing medications within 180 days of the screening visit or\n  3. Discontinuation of vitamin E ≥800 IU\u002Fday for at least 180 days prior to the screening visit.\n* Subjects taking anti-diabetic medications must be on a stable dose for at least 90 days prior to the date of the screening visit.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.\n* No other anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) or investigational agent may be used from 28 days prior to registration and until the end-of-study visit.\n* Has previously received chemotherapy for metastatic disease (neoadjuvant or adjuvant therapy is allowed as long as treatment was completed ≥6 months prior to recurrence).\n* Has pre-existing grade ≥ 3 neuropathy precluding use of oxaliplatin.\n* Has known additional malignancy that is progressing or requires active treatment.\n* Has a known hypersensitivity to any of the study supplement\u002Fdrugs (SAMe, oxaliplatin, flourouacil, folinic acid and capecitabine).\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n* Has any gastrointestinal disorder (e.g., bowel obstruction) or neurologic condition (e.g., oropharyngeal dysphagia) that may result in impairment of oral intake, inability to swallow the oral supplement, and\u002For impairment of absorption of study drug in the opinion of the treating investigator.\n* Has previous clinical diagnosis of cirrhosis, has had known history of Hep A\u002FB\u002FC or nonalcoholic fatty liver disease (NAFLD), liver transplantation, or any other cause for decompensated liver disease.\n* Known human immunodeficiency virus (HIV) infection.\n* Any of the following within 6 months prior to the screening visit: unstable cardiovascular disease, myocardial infarction, coronary artery bypass surgery, coronary angioplasty, transient ischemic attack, or cerebrovascular accident.\n* Any other condition that, in the investigator's opinion, would impede competence or compliance or delay completion of the study.\n* History of Parkinson's disease or bipolar disorder.\n\nPatients taking the following prohibited medications:\n\n* Olanzapine\n* MAO inhibiters, including:\n\n  * Isocarboxazid\n  * Linezolid\n  * Methylene blue injection\n  * Phenelzine\n  * Rasagiline\n  * Selegiline\n  * Tranylcypromine\n  * Any other MAO inhibitors The above prohibited medications cannot be taken -14 days prior to Day 0 and during study treatment.. Patients currently on or plan to be prescribed anti-psychotic medications not listed above may be excluded at the discretion of the Investigator. - Active infection as evidenced by positive urine culture, blood culture, or pneumonia.",{"count":303,"type":22},[70],"This is an open-label, phase II study that may provide evidence that taking S-adenosylmethionine (SAMe) supplementation prevents oxaliplatin, a type of chemotherapy drug, associated liver toxicity in patients with resectable colorectal liver metastases. Resectable means that it is able to removed with surgery. Patients will take two SAMe tablets in the morning and one tablet in the evening for 3-6 months (about 6-8 cycles of chemotherapy) in addition to oxaliplatin based chemotherapy followed by surgical removal of the colorectal liver metastases.",[158,30,479,480,481,482,483],"Liver Metastasis Colon Cancer","Liver Injury","Sinusoidal Obstruction Syndrome","5-Fluorouracil Toxicity","Liver Toxicity, Chemically-Induced",[485,486,311],"S-adenosylmethionine","Oxaliplatin","2026-05-01",{"date":489,"type":49},"2026-05-06",{"date":491,"type":22},"2026-07",{"date":493,"type":22},"2028-08",{"name":495,"class":56},"Cedars-Sinai Medical Center",{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":504,"enrollmentInfo":505,"targetDuration":4,"studyType":67,"phases":507,"briefSummary":508,"conditions":509,"keywords":512,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":57},"100472167","incremental-value-of-magnetic-resonance-imaging-in-selection-of-pancreatic-cancer-patients-for-surgery-100472167","NCT05428358","Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery","Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery (MAGIPAC): A Randomized Clinical Trial.","MAGIPAC","Inclusion criteria:\n\n* Pancreatic cancer patients considered to have a locally resectable or borderline resectable tumor by the local hepato-pancreato-biliary multidisciplinary team board\n* No liver metastases on CT\n* At least 18 years old and able to provide informed consent\n* Expected pancreatic ductal adenocarcinoma based on CT scan\n\nExclusion criteria:\n\n* Metastatic disease\n* Prior receipt of neoadjuvant chemotherapy or downstaging\u002F-sizing treatment\n* Comorbidity rendering major surgery unfeasible (inoperable)\n* No informed consent\n* Unable to undergo MRI (Kidney insufficiency (eGFR \\\u003C 60 ml\u002Fmin\u002F1.73 m2 body surface ar-ea); Claustrophobia; Cardiac pacemaker)\n* Postoperative histology other than adenocarcinoma of pancreato-biliary origin.\n* MRI with liver-specific contrast performed during standard workup.","99 Years",{"count":506,"type":22},200,[102],"The aim of the study is to examine the incremental value of using magnetic resonance imaging (MRI) in addition to computed tomography (CT) in the diagnostic workup of pancreatic cancer patients.",[510,511,30],"Pancreatic Cancer","Pancreatic Neoplasm",[513],"magnetic resonance imaging","2026-04-28",{"date":516,"type":49},"2026-04-29",{"date":518,"type":49},"2022-08-30",{"date":520,"type":22},"2028-12-01",{"name":522,"class":56},"University of Aarhus",{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":533,"conditions":534,"keywords":540,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":90},"100635757","outcomes-after-liver-and-biliary-resection-at-a-high-volume-center-100635757","NCT07556835","Outcomes After Liver and Biliary Resection at a High-Volume Center","Ambispective Cohort Study of Clinical and Oncologic Outcomes in Patients Undergoing Liver and Biliary Resection at San Jacopo Hospital, Pistoia","BILIVER","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients undergoing liver resection and\u002For biliary resection at San Jacopo Hospital, Pistoia\n* Diagnosis of benign or malignant hepatobiliary disease\n* Availability of clinical, surgical, and follow-up data\n* For the prospective cohort, provision of written informed consent when required according to local regulations\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnancy\n* No liver or biliary resection performed\n* Biopsy only without resection\n* Refusal or unavailability of consent for the prospective cohort when consent is required",{"count":532,"type":22},1000,"The goal of this observational study is to evaluate clinical and oncologic outcomes in adult patients undergoing liver and\u002For biliary resection for benign and malignant diseases.\n\nThis study evaluates postoperative morbidity and mortality within 90 days after surgery, as well as overall survival and disease-free survival in patients with malignant disease.\n\nParticipants will:\n\n* undergo standard surgical and perioperative management according to routine clinical practice\n* have clinical, surgical, and follow-up data collected from institutional medical records\n* be followed for postoperative outcomes and long-term oncologic outcomes up to 5 years",[28,535,108,106,536,30,537,538,539],"Hepatobiliary Diseases","Liver Metastases From Colorectal Cancer","Biliary Tract Diseases","Benign Liver Disease","Gallbladder Carcinoma",[541,227,542,228,543,544,545,546,547,548,549,550,551,552,108],"Hepatobiliary surgery","Biliary resection","Postoperative complications","Postoperative mortality","Clavien-Dindo classification","Overall survival","Disease-free survival","Surgical outcomes","Observational study","Ambispective cohort","CRLM","HCC","2026-04-22",{"date":516,"type":49},{"date":556,"type":22},"2026-04",{"date":558,"type":22},"2036-12",{"name":560,"class":56},"Azienda USL Toscana Centro",{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":277,"enrollmentInfo":568,"targetDuration":4,"studyType":67,"phases":570,"briefSummary":571,"conditions":572,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":579,"locationsCount":90},"100537643","phase-2-neoadjuvant-serplulimab--bevacizumab-with-folfox-vs-folfox-alone-in-rasbraf-wt-pmmrmss-crc-patients-100537643","NCT06280495","Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS\u002FBRAF WT, pMMR\u002FMSS CRC Patients","Neoadjuvant Combination of Serplulimab and Bevacizumab With FOLFOX Versus FOLFOX Alone for Resectable Liver Metastases in RAS\u002FBRAF Wild-Type, pMMR\u002FMSS Colorectal Cancer Patients","Inclusion Criteria:\n\n* Age ≥18 and ≤75 years old\n* Histologically confirmed colorectal adenocarcinoma\n* Radiological and\u002For pathological confirmation of liver metastases, with ≤5 lesions\n* Genetic testing and\u002For immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR\u002FMSS\n* Absence of extrahepatic metastases confirmed by CT, MRI, or PET\u002FCT (if necessary)\n* Primary colorectal tumor has been or can be radically resected\n* Liver metastatic lesions are resectable (including radiofrequency ablation and SBRT), and postoperative NED (no evidence of disease) is expected. Resectable liver metastases are specifically defined as ① ≤5 metastatic lesions; ② R0 resection can be performed (including radiofrequency ablation and SBRT); ③ Sufficient residual liver volume is expected after resection; ④ At least one hepatic vein can be preserved after resection, with preserved blood flow in and out of the residual liver and preserved bile ducts, and can preserve at least two adjacent liver segments; ⑤ No extrahepatic metastases.\n* No prior anti-tumor therapy for liver metastases, except for surgical resection of primary lesions\n* Normal hematological function (platelets \\>90×109\u002FL; white blood cells \\>3×109\u002FL; neutrophils \\>1.5×109\u002FL)\n* Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminases ≤5 times ULN, alkaline phosphatase ≤2.5 ULN, no ascites, normal coagulation function, albumin ≥35g\u002FL\n* Liver function classified as Child-Pugh grade A\n* Serum creatinine below the upper limit of normal (ULN), or calculated creatinine clearance rate \\>50ml\u002Fmin (using Cockcroft-Gault formula)\n* ECOG performance status 0-1\n* Expected lifespan \\>3 months\n* Signed written informed consent\n* Willing and able to be followed up until death or end of study or study termination.\n\nExclusion Criteria:\n\n* Diagnosis of colorectal cancer with distant extrahepatic metastases\n* Prior chemotherapy, targeted therapy, intervention, or immunotherapy for liver metastases\n* No planned surgical resection for liver metastatic lesions\n* Received oxaliplatin-containing adjuvant chemotherapy regimen within the past one year\n* Any toxicity residuals from previous chemotherapy, excluding alopecia, such as peripheral neuropathy ≥NCI CTC v3.0 grade 2\n* Use of immunosuppressive drugs one week prior to study treatment initiation, excluding topical corticosteroids via nasal, inhalational, or other routes or physiological doses of systemic corticosteroids (i.e., not exceeding 10 mg\u002Fday of prednisone or equivalent) or steroids used for prevention of contrast agent allergy\n* Interstitial lung disease requiring corticosteroid treatment\n* Known active autoimmune disease requiring symptomatic treatment or with a history of such disease within the past 2 years. Patients with vitiligo, psoriasis, alopecia, or Graves' disease who have not required systemic treatment within the past 2 years, patients with hypothyroidism requiring only thyroid hormone replacement therapy, and patients with type I diabetes requiring only insulin replacement therapy can be included\n* Known history of primary immunodeficiency\n* Patients with active tuberculosis\n* History of allogeneic organ or hematopoietic stem cell transplantation\n* Known allergy to any monoclonal antibody or chemotherapy drug (Fluorouracil, oxaliplatin) preparation or excipient component\n* Bleeding tendency or coagulation disorder\n* Significant symptoms of intestinal obstruction\n* Hypertensive crisis or hypertensive encephalopathy\n* Severe uncontrolled systemic complications such as infection or diabetes\n* Clinically severe cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), hypertension that remains uncontrolled after appropriate drug treatment, unstable angina pectoris, congestive heart failure (NYHA 2-4), or arrhythmia requiring medication\n* Past or physical examination showing central nervous system diseases (such as primary brain tumor, epilepsy uncontrolled by standard treatment, any history of brain metastasis, or stroke)\n* Diagnosis of other malignant tumors within the past 5 years (excluding basal cell carcinoma and\u002For carcinoma in situ of the cervix after radical surgery)\n* Patients who received any investigational drug therapy within the last 28 days prior to the study\n* Pregnant or lactating women and women of childbearing age not using or refusing to use effective non-hormonal contraception (intrauterine devices, barrier contraception combined with spermicidal gel, or sterilization surgery) or men with reproductive potential unwilling or unable to comply with the study protocol",{"count":569,"type":22},156,[70,280],"The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases (RAS\u002FBRAF wild-type, pMMR\u002FMSS) compared to FOLFOX alone.",[158,30],"2026-04-15",{"date":575,"type":49},"2026-04-20",{"date":577,"type":49},"2024-02-01",{"date":142,"type":22},{"name":580,"class":56},"Sun Yat-sen University",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":67,"phases":590,"briefSummary":591,"conditions":592,"keywords":593,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":90},"100596354","histotripsy-plus-chemotherapy-vs-chemotherapy-alone-for-advanced-colorectal-liver-metastasis-100596354","NCT07044362","Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis","Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial","Inclusion Criteria:\n\n* Participants with liver-confined colorectal cancer liver metastasis (CRLM) or participants who have low-volume pulmonary disease along with CRLM\n* Participants receiving first line therapy with base of 5-FU with either oxaliplatin or irinotecan, or who are within 3 months of beginning chemotherapy, or participants who have completed chemotherapy treatment within 1 month of the histotripsy evaluation\n* Participants who have undergone other liver-directed therapy, such as ablation, embolization\n* Participants with multiple unresectable metastases that cannot be completely treated with resection and\u002For ablation\n* Participants aged ≥18 years\n\nExclusion Criteria:\n\n* Participants with resectable disease\n* Participants with non-pulmonary extra-hepatic disease including but not limited to bone or peritoneal metastasis.\n* Participants who are not able to tolerate general anesthesia\n* Participants who have Childs C Cirrhosis\n* Other non-skin malignancy within 2 years of study\n* WBC count \\\u003C 3,000 \u002FuL\n* Absolute Neutrophil Count \\\u003C 1,500 \u002FuL\n* History of Non-malignant serious concurrent illness that would increase the risk of histotripsy\n* Participants with MSI-High\n* Participants aged \\\u003C 18 years\n* Pregnant participants",{"count":589,"type":22},100,[102],"The goal of this clinical trial is to learn if histotripsy plus chemotherapy works to treat unresectable, bilobar liver- confined colorectal cancer liver metastasis (CRLM). The main question this clinical trial aims to answer is:\n\n• Does the management of this condition with uninterrupted palliative chemotherapy and histotripsy demonstrate improved progression-free survival?\n\nParticipants will:\n\n* Receive chemotherapy treatment per standard procedure.\n* Undergo histotripsy treatment according to current standard procedures at Cleveland Clinic.\n* Occasionally receive Computerized Tomography (CT) scan with and without contrast, give biopsy of treated and untreated liver lesions, and participate in a blood draw of up to 3 teaspoons at each in-person visit.\n* Participate in genetic testing, as a part of the standard of care for the treatment.",[158,30,105],[594,595,596,597,598,599,600],"Histotripsy","Liver-confined","Liver colorectal cancer liver metastasis","Liver-confined colorectal cancer liver metastasis","Chemotherapy","Advanced Colorectal","Advanced Colorectal Liver Metastasis","2026-03-18",{"date":603,"type":49},"2026-03-19",{"date":605,"type":49},"2025-06-30",{"date":607,"type":22},"2028-10-01",{"name":609,"class":56},"Case Comprehensive Cancer Center",{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":67,"phases":618,"briefSummary":619,"conditions":620,"keywords":621,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":90},"100373522","phase-2-tissue-analysis-after-tumor-ablation-for-liver-metastases-leading-to-immediate-retreatment-100373522","NCT04143516","Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment","Clinical Trial Optimizing Tumor Ablation for Liver Metastases: Rapid Tissue Analysis Allowing for Immediate Retreatment; Metabolic Imaging Biomarker Validation; and Predictive Genetic Signatures","Inclusion Criteria:\n\n* Diagnosis of liver metastases from various primary tumors\n* Confined liver disease or limited extrahepatic disease stable\u002Fcontrolled for at least 4 months (extrahepatic disease amenable to treatment is allowed)\n* Lesions of ≤3 cm in maximum diameter\n* At least one FDG-avid lesion to be treated\\*\\*\\*\n* INR \\\u003C 1.5\\*\n* Platelet count ≥ 50,000\n\nExclusion Criteria:\n\n* Age \\\u003C 18\n* Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from ablation injury with technical modifications such as hydro or air dissection\n* INR \\> 1.5 that cannot be corrected with fresh frozen plasma \\*\\*\n* Platelet count of \\\u003C50,000 that cannot be corrected with transfusion\n* More than 3 tumors in the liver\n* More than 5 tumors of extrahepatic disease (including mediastinal nodes and pulmonary nodules, abdominal or other lymph nodes, and bone metastasis)\n* Presence of any peritoneal Carcinomatosis\n\n  * For patients on Coumadin, general clinical guidelines for IR ablation will be followed.\n\n    * For patients with no FDG-PET avid tumors aim 2 of the protocol will not be assessed",{"count":506,"type":22},[70,280],"This study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. The results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.",[30],[622,623,624,625,626],"Optimizing Tumor Ablation","Rapid Tissue Analysis","Metabolic Imaging Biomarker Validation","Predictive Genetic Signatures","19-332","2026-03-17",{"date":603,"type":49},{"date":630,"type":49},"2019-10-25",{"date":632,"type":22},"2026-10",{"name":634,"class":56},"Memorial Sloan Kettering Cancer Center",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":641,"enrollmentInfo":642,"targetDuration":4,"studyType":67,"phases":643,"briefSummary":644,"conditions":645,"keywords":650,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":660,"completionDateStruct":662,"leadSponsor":664,"locationsCount":4},"100628445","phase-1-an-open-label-single-arm-dose-escalation-phase-i-study-evaluating-the-safety-tolerability-and-preliminary-efficacy-of-edb-102-in-patients-with-egfr-l858r-mutant-third-generation-tki-resistant-advanced-non-small-cell-lung-cancer-with-liver-metastases-100628445","NCT07461727","An Open-Label, Single-Arm, Dose-Escalation Phase I Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of EDB-102 in Patients With EGFR L858R-Mutant, Third-Generation TKI-Resistant Advanced Non-Small Cell Lung Cancer With Liver Metastases","Inclusion Criteria:\n\n1. Age ≥18 and ≤75 years, any sex.\n2. Histologically or cytologically confirmed, unresectable locally advanced or metastatic (stage IV) non-small cell lung cancer (NSCLC)\n3. Prior treatment with at least one third-generation EGFR-TKI (e.g., osimertinib) with radiologically confirmed disease progression according to RECIST 1.1 or intolerance, and no concomitant anticancer therapy during this period.\n4. Availability of tumor tissue obtained after progression on third-generation EGFR-TKI, with EGFR L858R mutation confirmed in the post-progression tumor tissue or blood sample by central laboratory- or study site-validated methods (e.g., WES or RNAseq).\n5. At least one measurable hepatic lesion per RECIST 1.1, confirmed by biopsy, with the EGFR L858R mutation verified in the lesion by central laboratory- or study site-validated methods (e.g., WES or RNAseq).\n6. ECOG performance status of 0 or 1.\n7. Adequate organ and bone marrow function: a) Hematologic: within 14 days prior to enrollment and without recent transfusion or growth factor therapy: ANC ≥1.5×10⁹\u002FL, Hb ≥90 g\u002FL, PLT ≥75×10⁹\u002FL, WBC \\>3.0×10⁹\u002FL. b) Hepatic: TBIL ≤1.5×ULN, ALT ≤5×ULN, AST ≤5×ULN. c) Renal: serum creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL\u002Fmin. d) Coagulation: PT ≤1.5×ULN, APTT ≤1.5×ULN, INR ≤1.5×ULN.\n8. Ability and willingness to provide written informed consent, comply with study procedures, and cooperate with study personnel.\n\nExclusion Criteria:\n\n1. Prior exposure to any gene-editing therapies (e.g., CRISPR, TALEN, ZFN)\n2. Receipt of chemotherapy, radiotherapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy, or other anticancer agents within 4 weeks prior to the first dose of study drug. For oral fluoropyrimidines or small-molecule targeted agents, the washout period is 2 weeks or 5 half-lives of the drug, whichever is longer\n3. Receipt of any investigational, unapproved therapy within 4 weeks prior to the first dose of study drug.\n4. Presence of other known driver gene alterations conferring TKI resistance, excluding EGFR mutations, unless these occur as co-mutations, including: Bypass pathway activation: High-level MET amplification: detected by WES (gene copy number \\>5) or FISH (MET\u002FCEP7 ratio ≥2.0). High-level HER2 amplification: detected by ISH (gene copy number ≥6 per nucleus, HER2\u002FCEP17 ratio ≥2.0). Other acquired resistance driver mutations: Newly emerged confirmed resistance mutations, e.g., KRAS or BRAF-V600E. Activating mutations in PI3K\u002FAKT\u002FmTOR pathway genes (e.g., PIK3CA). Loss of primary EGFR mutation: absence of the original EGFR L858R mutation in post-resistance tumor tissue.\n5. Known allergy or adverse reaction to any lipid nanoparticle (LNP) components.\n6. Uncontrolled hypertension (systolic BP \\>150 mmHg and\u002For diastolic BP \\>100 mmHg despite regular antihypertensive therapy) or history of hypertensive crisis or hypertensive encephalopathy.\n7. Liver disease, including cirrhosis, hepatitis, or history of hepatitis B or C infection.\n8. Unstable angina or acute myocardial infarction, or history of these events within the past 6 months.\n9. History of malignancy within the past 5 years, except for treated basal cell carcinoma, cutaneous squamous cell carcinoma, cervical cancer, or gastrointestinal cancers.\n10. Pregnant, breastfeeding, positive pregnancy test, or unwillingness to use contraception in premenopausal women. Women are considered postmenopausal if amenorrheic for ≥2 years. Male patients unwilling to use contraception during the study are also excluded.\n11. Leptomeningeal, brainstem, or spinal metastases, or active CNS metastases with compression. Subjects with previously treated brain metastases may participate if clinically stable ≥4 weeks prior to first study drug administration and off corticosteroids for ≥14 days.\n12. Any condition deemed by the investigator to make the subject unsuitable for participation in the study.","65 Years",{"count":183,"type":22},[69],"The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of EDB-102 Injection in patients with advanced non-small cell lung cancer (NSCLC) who have liver metastases. The study specifically targets patients harboring the EGFR-L858R mutation who have disease progression after treatment with third-generation EGFR tyrosine kinase inhibitors (TKIs, e.g., osimertinib).\n\nEDB-102 is a novel in vivo gene-editing therapy. It consists of CRISPR-Cas9 mRNA and a single-guide RNA (sgRNA) encapsulated in lipid nanoparticles (LNPs). The drug is designed to specifically identify and disrupt the mutant EGFR-L858R gene in tumor cells, thereby inhibiting tumor growth. Due to the liver-targeting properties of the LNP carrier, this therapy is particularly aimed at patients with liver metastases.\n\nThis is a Phase I, open-label, dose-escalation study. Participants will receive a single intravenous (IV) infusion of EDB-102. The study will follow a \"3+3\" design to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). Participants will be monitored for adverse events, and tumor biopsies will be collected to assess the gene-editing efficiency of the drug.",[646,647,30,648,649],"Non-Small Cell Lung Cancer","Metastatic Non-small Cell Lung Cancer","EGFR Gene Mutation","EGFR L858R",[651,652,649,653,654,655,656],"EDB-102","CRISPR-Cas9","Lipid Nanoparticles (LNP)","In vivo Gene Editing","TKI Resistance","Osimertinib Resistance","2026-03-05",{"date":659,"type":49},"2026-03-10",{"date":661,"type":22},"2026-02-10",{"date":663,"type":22},"2029-01-31",{"name":665,"class":56},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":667,"slug":668,"hasResults":12,"nctId":669,"briefTitle":670,"officialTitle":670,"acronym":671,"eligibilityCriteria":672,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":673,"targetDuration":4,"studyType":67,"phases":675,"briefSummary":676,"conditions":677,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":90},"100543939","phase-3-ultra-high-dose-radiation-for-liver-metastasis-using-mr-guided-treatment-with-stereotactic-ablative-single-fraction-100543939","NCT06362395","Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction","ULTRAS","Inclusion Criteria:\n\n* Histologically confirmed malignancy (colorectal adenocarcinoma, pancreatic adenocarcinoma, head and neck SCC, cervix SCC, skin SCC and NSCLC) with metastatic liver disease detected on imaging. Biopsy of metastasis is preferred, but not mandatory.\n* One, two or three liver metastases \"target lesion\", ≥ 2 cm from luminal and biliary structures\n* Target lesions(s) that can receive high\u002Fultra-high dose SBRT: Maximum number: 3, Maximum diameter of each target lesion: 6cm\n* Non-target lesion(s) can be treated with 3- or 5-fraction SBRT for non-target liver metastases\n* Patients must be Child-Pugh score A within one month prior to study entry.\n* Must be ≥ 18 years of age.\n* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Expected life expectancy \\> 6 months.\n* Suitable for MR-linac treatment (e.g., ability to lie on the treatment couch for at least one hour)\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.\n* Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in English. The baseline assessment must be completed within required timelines, prior to treatment start. Inability (lack of comprehension in English, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study.\n* Women of child bearing potential must use an accepted and effective method of contraception and\u002For abstain from sexual intercourse while on protocol treatment and for at least 6 months after the last day of RT. Sexually active males must use an accepted and effective method of contraception and\u002For abstain from sexual intercourse while on protocol treatment and for at least 6 months after SBRT.\n* Women must not be pregnant or breast-feeding. All females of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 4 weeks prior to registration. All breastfeeding women should discontinue breastfeeding prior to study registration.\n\nExclusion Criteria:\n\n* Liver metastases from primary cancer other than listed in the eligibility criteria (i.e., tumor with low α\u002Fβ ratio).\n* Target lesion \"planned for high\u002Fultra-high dose SBRT\" in proximity (\\\u003C2cm) to luminal or biliary structures.\n* Evidence of \\> 5 liver metastases (exception is in cases of oligoprogression, patients may have more than 5 liver metastases, but SBRT for target lesions will be required for 1, 2, or 3 liver metastases only).\n* Any previous RT to the abdomino-pelvic region that would result in significant overlap of RT volume for the current study.\n* Previous liver-directed transarterial radioembolization (note that previous transarterial chemoembolization, microwave ablation, or radiofrequency ablation are permitted).\n* Individuals with severe, active co-morbidity including any of the following:\n* Chronic obstructive pulmonary disease or other pulmonary illness requiring hospitalization within 30 days of study registration\n* Unstable angina and\u002For congestive heart failure requiring hospitalization within the 30 days of study registration\n* Acute myocardial infarction within 30 days of study registration\n* Diseases precluding RT (e.g., active scleroderma, lupus or inflammatory bowel disease)\n* Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical devices.\n* History of claustrophobia\n* The total length of treatment volume is beyond the capacity of MRL machine\n* Participants must not be receiving any other standard anti-cancer therapy or experimental agent concurrently with SBRT (≥1 week break of systemic therapy prior to SBRT is required).",{"count":674,"type":22},114,[280],"This international multi-centre phase 3 randomized control trial investigates whether giving a very high dose of radiation in a single treatment session (ultra-high dose: experimental) using advanced technology called MR-Linac is more effective than a high dose (control) for treating liver tumors that have spread from other parts of the body (liver metastases). This study also aims to identify predictors of treatment response and side effects by analyzing various factors such as imaging markers and genetic profiles.\n\nLiver metastases are common in several cancers, but surgery is often not feasible for many patients. Stereotactic body radiotherapy (SBRT), which delivers focused radiation to tumors, is an alternative treatment option. Previous studies have shown promising results with SBRT, but the optimal radiation dose for liver metastases is still uncertain.\n\nThis study will look at patients with specific types of primary cancers known to respond well to SBRT. Treatment effectiveness will be assessed by monitoring tumor control, overall survival, and quality of life.\n\nBy comparing ultra-high dose SBRT with standard high dose, the study aims to determine if the former can provide better tumor control with fewer side effects. If successful, this approach could offer a significant advancement in the treatment of liver metastases, potentially improving outcomes and quality of life for patients.",[30],"2026-03-03",{"date":680,"type":49},"2026-03-04",{"date":682,"type":49},"2024-12-05",{"date":684,"type":22},"2031-09",{"name":686,"class":56},"University Health Network, Toronto",{"id":688,"slug":689,"hasResults":12,"nctId":690,"briefTitle":691,"officialTitle":692,"acronym":693,"eligibilityCriteria":694,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":695,"targetDuration":697,"studyType":23,"phases":4,"briefSummary":698,"conditions":699,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":733,"startDateStruct":734,"completionDateStruct":736,"leadSponsor":738,"locationsCount":740},"100368284","the-momentum-study-the-multiple-outcome-evaluation-of-radiation-therapy-using-the-mr-linac-study-100368284","NCT04075305","The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study","The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study","MOMENTUM","Inclusion Criteria:\n\n* Patient is to undergo or has completed imaging or treatment procedures on an MR-Linac;\n* Patient provides written, informed consent;\n* Patient is 18 years old or older.\n\nExclusion Criteria:\n\n* MRI exclusion criteria, including\n* MRI contraindications as per usual clinical care, such as (possible) pregnancy; claustrophobia and metal or electronic implants not compatible with MRI.",{"count":696,"type":22},8000,"2 Years","The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.",[700,701,702,703,704,705,706,707,708,709,710,711,712,713,714,715,716,717,718,719,720,721,722,723,510,724,725,726,727,728,729,432,730,731,105,28,30,732],"Oncology","Breast Cancer","Prostate Cancer","Gynecologic Cancer","Brain Tumor","Brain Cancer","Gynecologic Tumor","Prostate Tumor","Prostate Neoplasm","Breast Tumor","Radiation Toxicity","Quality of Life","Rectal Cancer","Rectal Tumor","Rectal Neoplasms","Lung Cancer","Lung Tumor","Lung Neoplasm","Esophageal Cancer","Esophagus Cancer","Esophageal Tumor","Esophageal Neoplasm","Esophagus Tumor","Esophagus Neoplasm","Pancreatic Tumor","Pancreatic Neoplasms","Head and Neck Cancer","Head and Neck Neoplasms","Head and Neck Tumor","Tumor","Bladder Cancer","Bladder Neoplasm","Oligometastases",{"date":657,"type":49},{"date":735,"type":49},"2019-02-01",{"date":737,"type":22},"2030-08-01",{"name":739,"class":56},"UMC Utrecht",18]