[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colorectal-liver-metastasis-crlm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colorectal-liver-metastasis-crlm":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,97,123,147],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100622584","the-use-of-artificial-intelligence-for-the-prediction-of-recurrence-after-resection-of-colorectal-liver-metastases-100622584",false,"NCT07385521","The Use of Artificial Intelligence for the Prediction of Recurrence After Resection of Colorectal Liver Metastases","A Retrospective Observational Study to Use Artificial Intelligence for Prediction of Disease REcurrence of COlorectal Cancer Liver METastasis After Hepatic Resection","AI-RECOLMET","Inclusion Criteria:\n\n* Pathologically confirmed diagnosis (at final pathology) of liver metastases from colon or rectal adenocarcinoma\n* \\> 6 months of follow-up\n* no other concomitant neoplastic disease\n\nExclusion Criteria:\n\n* All subjects receiving hepatic resection but not fulfilling the inclusion criteria","ALL","18 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","Colorectal cancer is the third most common cancer worldwide and the fourth most common cause of cancer-related death. Survival is primarily determined by stage of disease and the presence of metastases. The combination of chemotherapy and liver resection remains the treatment option with the highest survival benefit for patients with liver metastases from colorectal cancer, with surgery still being the only recognized potential curative treatment; surgical locoregional treatment can also be combined with thermal ablation to enhance the possibility of complete liver clearance. Despite significant improvements in prognosis, a large proportion of patients (almost half) will still experience recurrence following treatment. There is a clinical need to identify a priori patients who are different likely to develop disease recurrence after locoregional treatment (liver resection ± thermal ablation) and to respond differently to chemotherapy, in order to refine risk-based allocation of treatments and resources. Widespread digitalization of healthcare generates a large amount of data, and together with today accessible high-performance computing, artificial intelligence technologies can be applied to overcome the current limitations in estimating colorectal cancer liver metastases recurrence and response to locoregional and chemotherapy treatments, thus achieving better treatment allocation than current practice. All radiomic features can also help in training the neural network aimed at detecting liver metastases before they become visually detectable by the radiologist. Therefore, this study aims to evaluate whether a multifactorial machine learning model (including clinical and radiomic) can identify patients with colorectal cancer liver metastases with a high risk of progression after chemotherapy and recurrence after liver resection",[25,26,27,28],"Colorectal Liver Metastasis (CRLM)","Liver Resection","Hepatectomy","Liver Ablation",[30,31,27,32,33,34],"Colorectal liver metastases","Liver resection","Liver ablation","Machine learning (ML)","Artificial Intelligence (AI)","RECRUITING","2026-01-29",{"date":38,"type":39},"2026-02-04","ACTUAL",{"date":41,"type":39},"2025-02-19",{"date":43,"type":21},"2027-02-19",{"name":45,"class":46},"Francesco De Cobelli","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":68,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100617686","phase-2-injection-of-ip-001-into-thermally-ablated-hepatic-tumors-in-patients-with-colorectal-liver-metastases-100617686","NCT07321847","Injection of IP-001 Into Thermally Ablated Hepatic Tumors in Patients With Colorectal Liver Metastases","Intratumoral Injection of IP-001 Following Standard-of-care Complete Hepatic Tumor Ablation in Patients With Liver-only Metastatic Colorectal Cancer","INJECTABL-3","Inclusion Criteria:\n\n1. Patients ≥ 18 y of age at the time of signing the Informed Consent Form in accordance with local regulatory and\u002For national laws and International Council for Harmonisation (ICH)\u002FGood Clinical Practice (GCP) regulations (consent must be received before any study-specific activity is performed).\n2. Patients with liver-only metastatic CRC (and no radiologic or clinical evidence of extrahepatic metastases) with:\n\n   1. No more than 5 CRLM (≤ 3 cm for largest diameter)\n   2. An indication to receive percutaneous or laparoscopic SOC complete CRLM ablation with the intent of leaving no detectable liver disease\n   3. Tumors amenable to ablation treatment in a single session\n   4. No residual primary colorectal tumor at Treatment Day 1 or plans to have the primary tumor excised within 4-12 weeks following Treatment Day 1. (Patients with rectal cancer who underwent chemoradiotherapy for the primary cancer must have a complete clinical response.)\n3. Prior systemic anticancer treatment for metastatic colorectal cancer is permitted but not required. Patients must have received no more than two prior lines of systemic anticancer treatment for mCRC.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 2.\n5. Patients with adequate hematological function (defined as an absolute neutrophil count ≥ 1.5 × 109\u002FL, hemoglobin level ≥ 9 g\u002FdL, and platelet count ≥ 50 × 109\u002FL) and coagulation function (defined as a partial thromboplastin time \\[PTT\\] or activated PTT \\[aPTT\\] and international normalized ratio \\[INR\\] ≤ 1.5 × the upper limit of normal \\[ULN\\]). (Note: the criteria for adequate hematological function must be met without erythropoietin dependency, use of growth factors, or the requirement for transfusions of blood, coagulation factors, platelets, or albumin within 14 d of Treatment Day 1.)\n6. Patients with adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransaminase (ALT) levels of ≤ 5 × the ULN, and a total bilirubin level ≤ 1.5 × the ULN (patients with documented Gilbert disease are allowed to participate in the study if their total bilirubin level is ≤ 3 × the ULN).\n7. Patients with adequate renal function, defined as an estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin or an estimated creatinine clearance ≥ 40 mL\u002Fmin (measured or calculated using the Cockcroft-Gault formula).\n8. Women with childbearing potential (WOCBP)\n\n   1. Must have a negative serum human chorionic gonadotropin pregnancy test in the Screening Period.\n   2. Are using highly effective contraception, are not lactating, and agree not to become pregnant during the trial treatment period and for 187 days after treatment with the investigational drug.\n9. Men agree not to donate sperm or to father a child during the trial treatment period and for 97 days after treatment with the investigational drug.\n\nExclusion Criteria:\n\n1. Patients from vulnerable populations (incapacitated or unconscious individuals, persons deprived of liberty).\n2. Patients with a known allergic reaction or hypersensitivity to shellfish, crabs, crustaceans, or any components used in trial treatment.\n3. Patients with any prior treatment with IP-001 for Injection in a different clinical trial.\n4. Patients who underwent any surgical liver resection, hepatic ablation or other hepatic locoregional therapy for CRLM within 3 months before Treatment Day 1; patients who received any other medical procedure, SACT, or treatment with any other investigational anticancer agents within 14 days before Treatment Day 1, or patients who at study enrollment have plans to receive SACT or locoregional therapies\u002Fprocedures prior to intrahepatic or extrahepatic progression.\n5. Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 d of randomization. Inhaled or topical steroids and adrenal replacement steroid doses (\\> 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.\n6. Patients who at screening have not recovered back to baseline or ≤ Grade 1 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) guidelines v6.0 from ongoing conditions related to any prior medicinal or procedural treatments (including major surgery) except for residual toxicities, unless conditions are deemed clinically non-significant by the Investigator and\u002For stable on supportive therapy (in consultation with Sponsor Medical Monitor), such as alopecia or Grade 2 neuropathy.\n7. Patients with any extrahepatic nodal or non-nodal CRC metastases, except:\n\n   1. History of infiltrated regional lymph nodes associated with the primary tumor if these lymph nodes were removed together with the primary tumor.\n   2. Pulmonary nodules unless they are considered suspect for metastases because they show at least one of the following characteristics:\n\n   i. new or increasing in size (at least 20% increase in longest diameter) in the last 12 mo; ii. unequivocal 18F-FDG tracer-uptake on PET; iii. solitary nodule \\>1 cm; iv. 2 - 5 nodules with at least 1 ≥ 0.8 cm; v. more than 5 nodules (excluding nodules that are stable in size over at least 1 y).\n8. Patients with a history of another active malignancy within 2 years prior to Treatment Day 1, except for superficial skin cancers or localized, low-grade tumors deemed cured and not treated with systemic therapy. Patients with incidental prostate cancer may enroll if Stage ≤ T2N0M0 and Gleason score ≤ 6.\n9. Patients with bleeding diathesis or anti-coagulation treatment that cannot be stopped 24 hours prior to Treatment Day 1 (low-dose aspirin will be allowed).\n10. Patients who have one of the following cardiovascular disorders:\n\n    1. Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association classification III or IV), or\n    2. Unstable angina pectoris or a history of myocardial infarction within the last 6 mo, or\n    3. Serious arrhythmias requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia), or\n    4. Significant QT-prolongation (QTcF ≥ 480 msec on screening electrocardiogram \\[ECG\\] \\[QTcF interval is not relevant in patients with pacemaker-controlled arrythmia\\]), or\n    5. Uncontrolled hypertension, defined as a resting systolic blood pressure \\> 150 mmHg and\u002For resting diastolic blood pressure \\> 90 mmHg, which cannot be controlled by anti-hypertensive therapy.\n11. Patients with any of the following infections\u002Fdiseases:\n\n    1. Known history of human immunodeficiency virus infection,\n    2. Known active Hepatitis B or C viral infection,\n    3. Any uncontrolled active systemic infection requiring intravenous antimicrobial treatment during screening,\n    4. Any active, known, or suspected autoimmune disease.\n12. Patients with a requirement for hemodialysis or peritoneal dialysis.\n13. Patients with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan or cavitating pulmonary lesion(s) or a known endobronchial disease manifestation.\n14. Patients who received a live, attenuated vaccine within 28 days of Treatment Day 1.\n15. Patients with any other serious underlying medical, psychological, familial, or geographical condition that, in the judgment of the Investigator, may limit compliance with the study or place the patient at high risk for treatment-related complications.",{"count":57,"type":21},717,"INTERVENTIONAL",[60,61],"PHASE2","PHASE3","The goal of this clinical trial is to learn if a new injectable drug (IP-001), administered after standard liver tumor ablation, can help prevent cancer from returning in people (males\u002Ffemales, ≥18 years old) with colorectal cancer that has spread only to the liver. The study will determine if injecting IP-001 into a liver tumor(s) after ablation will reduce the risk of cancer coming back in the liver and from spreading elsewhere in the body, will stimulate the immune system, will have any side effects, and will help improve a patient's response to other cancer therapies.\n\nResearchers will compare a standard of care liver ablation alone (microwave ablation \\[MWA\\], a technique that destroys tumors using heat), with MWA plus a high-dose IP-001 or MWA with a low-dose IP-001. During the treatment procedures, the doctor first performs the standard microwave ablation to destroy the tumor. Then, in the experimental-drug arms, IP-001 is injected in and around the treated tumor area to activate the immune system locally so that the body is more likely to find and eliminate any remaining cancer cells.",[64,65,66,67,25],"Colorectal Cancer (CRC)","Colon Cancer Liver Metastases","Rectal Cancer","Rectal Cancer With Liver Metastases",[30,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85],"Colorectal cancer","Microwave ablation","Thermal ablation","Intratumoral immunotherapy","Intratumoral injection","Immune activation","Ablation-induced immunity","Liver tumor ablation","Metastatic cancer","Cancer","IP-001","Tumor ablation","Systemic immune response","Interventional immuno-oncology","Interventional oncology","Abscopal effect","T-cell stimulation","NOT_YET_RECRUITING","2026-01-05",{"date":89,"type":39},"2026-01-07",{"date":91,"type":21},"2026-05",{"date":93,"type":21},"2033-12",{"name":95,"class":96},"Immunophotonics, Inc.","INDUSTRY",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":104,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":47},"100616817","feasibility-of-circulating-tumour-dna-ctdna-analysis-using-automated-capillary-blood-sampling-100616817","NCT07310537","Feasibility of Circulating Tumour DNA (ctDNA) Analysis Using Automated Capillary Blood Sampling","ctDNA TAP","Inclusion Criteria:\n\n* Age ≥ 21 years\n* A history of histologically confirmed (metastatic) colorectal adenocarcinoma\n* Currently diagnosed with (progressive) colorectal liver metastases (CRLM)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients who are treated and having a response on chemotherapy, as this may have an effect on the investigated biomarker load\n* Illiteracy and\u002For insufficient proficiency of the Dutch language\n* Known medical history of superficial or deep skin infection after venipuncture or intravenous line that required antibiotic treatment and or hospital admittance\n* Known medical history of immunodeficiency or current use of medical immunosuppressants\n* Known medical history of blood-borne diseases such as, but not limited to, the human immunodeficiency virus, hepatitis and viral hemorrhagic fever","21 Years",{"count":106,"type":21},35,"The goal of this observational study is to investigate whether circulating tumor-derived DNA (ctDNA) can be reliably detected and analyzed in blood obtained through automated capillary sampling in adult patients (≥21 years) with colorectal liver metastases (CRLM).\n\nThe main question it aims to answer is:\n\n* Can ctDNA be detected in small volumes of capillary blood collected using an automated sampling device?\n* Do ctDNA levels measured in capillary blood agree with those measured in venous blood from the same patients?\n\nResearchers will compare ctDNA measurements from capillary blood to those from venous blood (reference standard) to see if capillary sampling provides reliable results for ctDNA analysis.\n\nParticipants will:\n\n* Provide a small blood sample through automated capillary collection.\n* Provide a venous blood sample during the same study visit for comparison.",[109,25,110],"Colorectal Cancer (Diagnosis)","Circulating Tumor DNA (ctDNA)",[112,25,110,113],"Colorectal Cancer","Automated Capillary Blood Sampling","2026-01-02",{"date":116,"type":39},"2026-01-06",{"date":118,"type":39},"2025-11-17",{"date":120,"type":21},"2027-11",{"name":122,"class":46},"Erasmus Medical Center",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":47},"100595065","multi-reader-multi-case-trial-evaluating-computer-aided-tool-for-prognostic-prediction-of-colorectal-liver-metastases-100595065","NCT07027605","Multi-Reader Multi-Case Trial Evaluating Computer-Aided Tool for Prognostic Prediction of Colorectal Liver Metastases","A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Performance Improvement From Computer-aided Tool for the Prognostic Prediction of Colorectal Liver Metastases","Inclusion Criteria:\n\n* ≥ 18 years old\n* confirmation of histologically diagnosed liver metastases of colorectal adenocarcinoma\n* receiving colorectal resection with simultaneous liver resection.\n\nExclusion Criteria:\n\n* presence of other malignancies\n* absence of follow-up data\n* patients who were followed up postoperatively for less than 5 years and had no occurrences of death.",{"count":131,"type":21},166,"This study evaluates the impact of a novel computer-aided prognostic prediction tool for colorectal liver metastases (CRLM) on clinician performance. Colorectal cancer is a leading cause of cancer-related mortality worldwide, with 20-30% of patients presenting synchronous liver metastases, which are associated with poor prognosis and high postoperative recurrence rates. Simultaneous resection of primary tumor and liver metastases is a preferred treatment for selected patients but outcomes vary significantly. The latest web-based tool uses Random Forest models integrating demographic, clinical, laboratory, and genetic data to predict postoperative recurrence and mortality specifically for CRLM patients undergoing simultaneous resection. This multiple-reader, multiple-case (MRMC) study will assess 12 physicians who will predict 1-, 3-, and 5-year recurrence and mortality risks in 166 retrospective cases, with and without the tool's aid, separated by a washout period. The primary focus is to determine whether the tool improves prediction accuracy for 3-year postoperative mortality, measured by AUC-ROC. Secondary and exploratory endpoints include other time points, sensitivity, specificity, inter-rater reliability, decision-making confidence, and evaluation time. By enabling individualized risk assessment, this tool aims to support optimized clinical decision-making and tailored treatment strategies for CRLM patients undergoing simultaneous resection.",[25],[135,136,137],"Multi-Reader Multi-Case Controlled Clinical Trial","Prognostic Prediction","Colorectal Liver Metastases","2025-08-17",{"date":140,"type":39},"2025-08-19",{"date":142,"type":39},"2025-01-01",{"date":144,"type":21},"2025-09-25",{"name":146,"class":46},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":58,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":47},"100592086","phase-2-folfox-haic-as-conversion-treatment-for-initially-unresectable-colorectal-liver-metastasis-100592086","NCT06988852","FOLFOX-HAIC as Conversion Treatment for Initially Unresectable Colorectal Liver Metastasis","Conversion Treatment With Hepatic Arterial Infusion of Oxaliplatin, Leucovorin and Fluorouracil Plus Intravenous Bevacizumab or Cetuximab for Initially Unresectable Colorectal Liver Metastasis: A Prospective Study","Inclusion Criteria:\n\n* age 18-75 years\n* no history of other malignant diseases\n* refuse or progress in prior systemic treatment\n* diagnosed as CRLM confirmed by pathology, in spite of whether the primary tumor had been resected\n* at least one lesion in the liver could be measured\n* left ventricular ejection ≥45%, forced expiratory volume in one second\u002Fforced vital capacity≥60% and Eastern Cooperative Oncology Group (ECOG) score of 0-1\n* Child-Pugh class A\n* adequate organ function, i.e.: white blood cell (WBC) ≥3.0×109\u002FL, neutrophils ≥1.5×109\u002FL, platelet (PLT) ≥75×109\u002FL, total bilirubin ≤30μmol\u002FL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤200U\u002FL, creatinine ≤150μmol\u002FL\n\nExclusion Criteria:\n\n* extra-hepatic metastasis verified by medical imaging\n* unable to tolerate chemotherapy, anesthesia or surgery\n* allergy or previous intolerable to any agent of oxaliplatin, leucovorin, 5-Fu, bevacizumab or cetuximab\n* tumor spread in abdomen\n* cerebral infarction, cerebral hemorrhage, gastrointestinal hemorrhage\u002Fperforation within 6 months, coagulation disorders and gastrointestinal ulcer\n* primary tumor may not be completely resected\n* prior treatment of CRLM with resection, ablation or radiation\n* incomplete clinical or follow-up data","75 Years",{"count":156,"type":21},300,[60],"Try FOLFOX-HAIC combining bevacizumab or cetuximab for initially unresectable colorectal liver metastasis patients to increase the conversion to resection rate to improve long-term survival outcomes",[25],"2025-05-23",{"date":162,"type":39},"2025-05-25",{"date":164,"type":39},"2023-05-01",{"date":166,"type":21},"2030-12-31",{"name":168,"class":46},"Tongji Hospital"]