[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-metastasis-colon-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-metastasis-colon-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,45,79,106,134,174,202,226,255,278,301,333,358,387,407,435,471,491,520,546,568,592,622,644],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100507233","preoperative-ketogenic-diet-for-reduction-of-hepatic-steatosis-100507233",false,"NCT05884723","Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis","Implementation of a Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis Prior to Hepatectomy: a Randomized Control Trial","Inclusion Criteria:\n\n* Patients 18 years of age or older undergoing any type of liver resection (e.g. wedge, formal hepatectomy), either open or laparoscopic, for colorectal liver metastases (CRLM)\n* Patients with evidence of hepatic steatosis on pre-operative imaging (CT or MR) or biopsy.\n* Ability to use an app based nutritional program to track macronutrient uptake throughout the dietary intervention.\n\nExclusion Criteria:\n\n* Patients undergoing liver resection for any other indication\n* Patients on sodium glucose co-transporter 2 (SGLT-2) inhibitors (these are contraindicated with a ketogenic diet).\n* Patients without evidence of hepatic steatosis.\n* Patients with evidence of liver fibrosis or cirrhosis on preoperative bloodwork or imaging.\n* Patients with alcohol-related hepatic steatosis.\n* Patients with a known bleeding disorder.","ALL","18 Years",{"count":19,"type":20},124,"ESTIMATED","INTERVENTIONAL",[23],"NA","Non-alcoholic fatty liver disease is becoming increasingly common in Canada and throughout the world. Fatty liver can increase the risks of perioperative complications for those who need liver surgery. A ketogenic diet is low in carbohydrates and can be very effective in reducing liver fat content. The purpose of this randomized control trial is to compare the effect of a short duration (4 week) preoperative ketogenic diet on operative and disease outcomes in patients undergoing liver surgery. One arm will be randomized to the ketogenic diet and the other will receive standard of care pre-operative dietary consultation.",[26,27,28],"Liver Steatoses","Liver Metastasis Colon Cancer","NAFLD",[30,28,31],"ketogenic diet","colorectal liver metastases","RECRUITING","2026-05-15",{"date":35,"type":36},"2026-05-19","ACTUAL",{"date":38,"type":36},"2024-05-01",{"date":40,"type":20},"2032-12",{"name":42,"class":43},"Anton Skaro","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"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":53,"type":20},30,[55],"PHASE2","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.",[58,59,27,60,61,62,63],"Colorectal Cancer","Liver Metastases","Liver Injury","Sinusoidal Obstruction Syndrome","5-Fluorouracil Toxicity","Liver Toxicity, Chemically-Induced",[65,66,67],"S-adenosylmethionine","Oxaliplatin","Stage IV colorectal cancer","NOT_YET_RECRUITING","2026-05-01",{"date":71,"type":36},"2026-05-06",{"date":73,"type":20},"2026-07",{"date":75,"type":20},"2028-08",{"name":77,"class":43},"Cedars-Sinai Medical Center",2,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100524620","guidemrd-01-crc-clinical-validation-and-benchmarking-of-top-performing-ctdna-diagnostics---colorectal-cancer-100524620","NCT06111105","GUIDE.MRD-01-CRC: Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Colorectal Cancer","GUIding Multi-moDal thErapies Against MRD by Liquid Biopsies in Colorectal Cancer - GUIDE.MRD-01-CRC","Colorectal cancer stage III\n\nInclusion Criteria:\n\n* Colorectal cancer, UICC stage III\n* Has received curative-intent resection and is a candidate for adjuvant chemotherapy\n* Patient able to understand and sign written informed consent\n\nExclusion Criteria:\n\n* Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome\n* Inflammatory bowel disease (Crohn's disease or ulcerative colitis)\n* Verified distant metastases\n* Not treated with adjuvant chemotherapy despite indication (incomplete treatment not included)\n* Treated with neoadjuvant chemo-radiation therapy\n* No tissue sample available for the project, or tumor content in the tissue sample is \\\u003C20%\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\nColorectal cancer liver metastasis\n\nInclusion Criteria:\n\n* Colorectal cancer liver metastasis\n* Planned for curative-intent treatment\n* Performance status 0-1\n\nExclusion Criteria:\n\n* Liver cirrhosis\n* Extrahepatic metastases\n* Other cancer within the last 5 years\n* Intervention not performed with curative intent\n* No tissue available from CRLM or primary tumor",{"count":87,"type":20},590,"OBSERVATIONAL","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\nGUIDE.MRD-01-CRC is a part of the GUIDE.MRD project.",[91,27],"Colorectal Cancer Stage III",[93,94,95],"Circulating tumor DNA","ctDNA diagnostics","Minimal residual disease","2026-04-28",{"date":98,"type":36},"2026-05-04",{"date":100,"type":36},"2023-08-01",{"date":102,"type":20},"2031-07-31",{"name":104,"class":43},"Claus Lindbjerg Andersen",15,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":44},"100622260","phase-2-oncolytic-virus-h101--sbrt--chemotherapy--targeted-therapy--immunotherapy-for-unresectable-crlm-100622260","NCT07381309","Oncolytic Virus (H101) + SBRT + Chemotherapy + Targeted Therapy + Immunotherapy for Unresectable CRLM","Oncolytic Virus (H101) Peritumoral Injection Combined With SBRT, Chemotherapy, Targeted Therapy, and Immunotherapy for Unresectable MSS\u002FpMMR Colorectal Cancer Liver Metastases (CRLM)","VVSHIP","Inclusion Criteria:\n\n1. The patient or their legal representative understands and signs the informed consent form.\n2. Patients with pMMR\u002FMSS colorectal adenocarcinoma.\n3. Aged 18-75 years.\n4. Patients with histologically or cytologically confirmed colorectal cancer liver metastases. There must be at least one injectable lesion in the liver, which must also meet the criteria for a measurable target lesion according to RECIST version 1.1 (≥10 mm in the longest diameter on spiral CT\u002FMRI scan with a slice thickness of no greater than 5 mm).\n5. Patients with definitively unresectable metachronous liver metastases; OR patients deemed surgically resectable but who refuse surgery, provided the liver metastases meet the following requirements: ① The number of metastatic lesions must be no more than 5, and the sum of the longest diameters of all metastatic lesions must be ≤100 mm; ② The longest diameter of a single lesion must be ≤100 mm; ③ The longest diameter of the lesion to be injected must be ≥10 mm and ≤80 mm.\n6. The liver metastases have not received prior radiotherapy, OR the area of the liver near the planned radiotherapy site has not been previously irradiated. At least 700 cc of liver volume must be preserved outside the treatment area.\n7. Prior treatments such as hepatic resection, systemic chemotherapy, local ablation therapy, or hepatic artery infusion pump chemotherapy are allowed, provided a washout period of 2 weeks is observed. Patients must have recovered from prior anti-tumor therapy-related adverse events to baseline or Grade ≤1 (according to CTCAE version 5.0) (excluding alopecia and Grade 2 anemia).\n8. Child-Pugh score A or B\n9. ECOG Performance Status 0-1\n10. Peripheral blood counts and liver\u002Frenal function within the allowable ranges (tested within 15 days before treatment initiation)\n11. No prior history of other concomitant malignancies. Patients must not be pregnant or breastfeeding and should use effective contraception during the study and for 6 months after the last dose.\n12. Life expectancy ≥6 months.\n\nExclusion Criteria:\n\n1. Synchronous colorectal cancer liver metastases.\n2. Active hepatitis, cirrhosis, or Child-Pugh class C.\n3. Extralepatic metastases to: central nervous system \u002F bone marrow \u002F brain (UICC 8th edition).\n4. Liver metastases not measurable.\n5. Prior history of oncolytic virus therapy (e.g., T-VEC).\n6. Liver metastases not meeting the requirements for peritumoral injection volume or unsuitable for peritumoral injection.\n7. History of severe drug allergy (e.g., to oncolytic adenovirus, PD-1 monoclonal antibody, platinum agents, 5-FU, leucovorin, 5-HT3 receptor antagonists, bevacizumab, etc.).\n8. Antiviral therapy (e.g., acyclovir, ganciclovir, valacyclovir, vidarabine) within 4 weeks prior to the first dose of study treatment.\n9. Participation in another clinical trial within 4 weeks or ongoing participation.\n10. History of prior therapy targeting PD-1, PD-L1, PD-L2, CTLA-4, or any other T-cell co-stimulation or checkpoint pathway.\n11. Severe electrolyte abnormalities.\n12. Significant portal hypertension: history of upper gastrointestinal bleeding or severe hypersplenism.\n13. Arterial or deep venous thrombosis within the past 6 months; history or evidence of bleeding tendency within the past 2 months.\n14. Pregnant or breastfeeding women, or women with a positive pregnancy test before the first dose; or female participants and their partners unwilling to use strict contraception during the study.\n15. Active autoimmune disease requiring systemic treatment (e.g., immunomodulators, corticosteroids, immunosuppressants) within the past 2 years.\n16. Past or current other active malignancies (except malignancies cured \\>3 years ago or carcinoma in situ treated curatively).\n17. Severe ECG abnormalities; active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina, or myocardial infarction within 12 months; New York Heart Association (NYHA) class II or higher congestive heart failure.\n18. Active infection (with fever \\>38°C).\n19. Poorly controlled hypercalcemia, hypertension, or diabetes.\n20. Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.).\n21. Psychiatric disorder affecting clinical treatment or history of central nervous system disease.\n22. Severe complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.).\n23. Persistent toxicity ≥ Grade 2 (CTCAE v5.0) from prior therapy (except anemia, alopecia, skin pigmentation).\n24. Use of any other investigational drug or participation in another interventional trial within 14 days prior to study treatment.\n25. Pregnant, breastfeeding, or planning pregnancy during the study; men or women unwilling to use effective contraception.\n26. Any unstable medical condition that may affect patient safety or compliance, as judged by the investigator to be unsuitable for the trial.","75 Years",{"count":116,"type":20},114,[55],"This prospective study aims to investigate the efficacy and safety of peritumoral injection of the oncolytic virus H101 in combination with stereotactic body radiotherapy (SBRT), PD-1 monoclonal antibody, chemotherapy, and targeted therapy for the treatment of patients with unresectable, microsatellite stable\u002Fmismatch repair proficient (MSS\u002FpMMR) colorectal adenocarcinoma liver metastases. The ultimate goal is to provide high-level evidence-based medical support for this combined modality approach.",[120,27],"CRC",[122,123,124,125],"Stereotactic body radiation therapy","Targeting Therapy","PD-1 Monoclonal Antibody","Oncolytic Virus","2026-04-22",{"date":96,"type":36},{"date":129,"type":20},"2026-06-01",{"date":131,"type":20},"2029-02-01",{"name":133,"class":43},"Jun Huang",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":144,"conditions":145,"keywords":157,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":44},"100573965","electrochemotherapy-ect-in-patients-with-primary-visceral-tumors-andor-secondary-visceral-localizations-of-any-histotype-100573965","NCT06753136","Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and\u002For Secondary Visceral Localizations, of Any Histotype","Treatment of Visceral Localizations With Electrochemotherapy in Patients With Primary Visceral Tumors and\u002For Secondary Visceral Localizations, of Any Histotype: Monocenter, Single Arm, Clinical Investigation","Inclusion Criteria:\n\n* Male\u002FFemale ≥ 18 years\n* Ability to understand the proposed treatment and express an informed acceptance by signing the informed consent\n* Diagnosis of primary and\u002For secondary visceral localizations of any histotype\n* Patients who are not eligible for standard curative procedures\n\nExclusion Criteria:\n\n* Absolute contraindications to invasive procedures\n* Concomitant presence of brain, lung, bone metastases\n* Uncorrectable coagulation changes\n* Bleomycin allergy\n* Absolute contraindications to taking Bleomycin\n* Poor respiratory function or pulmonary fibrosis\n* Acute lung infections\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study","99 Years",{"count":5,"type":20},[23],"This is an monocenter, single arm, clinical investigation that evaluate the impact of the method on the objective response rate (ORR) of visceral lesions undergoing electrochemotherapy. Electrochemotherapy is a well-defined method for the treatment of cutaneous and subcutaneous metastases of different tumor histotypes.\n\nAlthough still limited, the various experiences in the treatment of visceral localizations, particularly in liver metastases from colorectal cancer are promising and show that electrochemotherapy is a safe treatment, even in the case of lesions near large vessels or nerves. The investigators therefore propose a clinical investigation with a Medical Device according to EU Regulation 745\u002F2017, using electrochemotherapy (Cliniporator) with bleomycin for the treatment of visceral, primary or secondary, unresectable localizations, with percutaneous or intraoperative technique (laparoscopic or laparotomy), as needed.",[146,147,148,27,149,150,151,152,153,154,155,156],"Primary Visceral Tumors of Any Histotype","Visceral Lesions","Liver Cancer","Melanoma","Primary Pancreatic Tumor","Retroperitoneal Sarcoma","Abdominal and\u002For Peritoneal Localizations","Merkel Cell Carcinoma","Squamous Cell Carcinoma","Secondary Visceral Localizations of Any Histotype","Non-melanoma Skin Cancer",[158,159,160,161,162,163,164],"electrochemotherapy","visceral lesions","Laparoscopic procedure","Laparotomic procedure","Percutaneous procedure","bleomycin","medical device","2026-04-09",{"date":167,"type":36},"2026-04-13",{"date":169,"type":36},"2025-07-23",{"date":171,"type":20},"2030-02-28",{"name":173,"class":43},"Istituto Oncologico Veneto IRCCS",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":183,"conditions":184,"keywords":189,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":44},"100413844","biopsy-after-radioembolization-to-identify-changes-in-tumor-cells-from-the-radiation-100413844","NCT04668872","Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation","Correlation of Histopathological Findings With Radiation Exposure Levels After Y90 Transarterial Radioembolization (TARE) of Hepatic Metastases: A Feasibility Study","Inclusion Criteria:\n\n* age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* histologically confirmed primary adenocarcinoma of the colon or rectum\n* CLM considered unresectable or not amenable to percutaneous ablation\n* existent tissue samples from a standard of care biopsy of the target tumor within 42 days prior to treatment OR clinical indication for biopsy at the time of the treatment under the institutional guidelines for progression of disease.\n* adequate blood cell counts (WBC \\> 1.5 x 109\u002FL, platelet count \\> 50 x 109\u002FL)\n* adequate renal function (creatinine \\\u003C 1.5 mg\u002FdL)\n* total bilirubin level ≤ 1.5 mg\u002FdL\n\nAdditional inclusion criteria for patients, undergoing 90Y radiation segmentectomy:\n\nA. patients not amenable to surgery or thermal ablation\n\nExclusion Criteria:\n\nStudy exclusion criteria will be similar to general TARE exclusion criteria, which are as follows:\n\n* prior hepatic radiotherapy (The lesion \u002F lobe being treated cannot have had prior treatment with radiotherapy - untreated lesions \u002F lobes in the liver may be evaluated under the protocol)\n* severe cirrhosis\n* severe portal hypertension\n* uncorrectable flow to the gastrointestinal tract and\u002For \\>30 Gy (or \\>50 Gy in multiple sessions) radiation absorbed dose to the lungs\n\nAll patients with liver-dominant disease will be considered candidates for TARE even in the face of oligometastatic (up to 5 sites) extrahepatic disease, that is stable or controlled by chemotherapy.",{"count":182,"type":20},80,"The purpose of this study is to study the way radioembolization works by collecting biopsy samples of participants' tumors after the procedure. This research may improve the way that radioembolization is performed, which could help people whose cancer has spread to the liver. The research may also provide information about how tumors respond to radioembolization.",[185,186,187,188,27,58],"Colon Cancer Liver Metastasis","Colon Cancer","Adenocarcinoma of the Colon","Adenocarcinoma of the Rectum",[31,190,191,185,186,187,188,58,192,193],"transarterial radioembolization","Y90 TARE","Memorial Sloan Kettering Cancer Center","20-355","2026-03-11",{"date":196,"type":36},"2026-03-12",{"date":198,"type":36},"2020-12-07",{"date":200,"type":20},"2026-12-07",{"name":192,"class":43},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":211,"conditions":212,"keywords":213,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":44},"100400261","selective-internal-radiation-therapy-with-90y-resin-micropheres-for-refractory-colorectal-cancer-liver-metastases-100400261","NCT04491929","Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases","Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases - SIRT - A Translational Feasibility Study","SIRT","Inclusion Criteria:\n\n* Diagnosis of metastatic colorectal adenocarcinoma with liver dominant disease\n* Diagnosis of liver metastasis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.\n* The Liver metastasis are not eligible for resection, RFA or SBRT\n* All patients must be off all chemotherapeutic regimens for 14 days prior to SIRT treatment\n* All patients must be off vascular endothelial growth factor inhibitors for 6 weeks prior to SIRT treatment\n* Progressive disease, severe intolerance during or following all standard lines of chemo-therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Age 18 years or older\n* Able to understand written information\n* Consent to samples for translational research\n\nExclusion Criteria:\n\n* Pretherapeutic work-up procedure with Tc-99m macroaggregated albumin (MAA) scintigraphy showing extrahepatic foci in GI-tract\n* Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition\n* Previous radiation therapy to the lungs and\u002For to the upper abdomen overlapping with dose to the liver at interventionist´s decision\n* Lung shunt greater than 20% or \\> 30 Gray radiation absorbed dose to the lungs, at estimated by Tc-99m-MAA\n* Pregnancy\n* Symptomatic lung disease precluding SIRT at interventionist´s decision\n* Active uncontrolled infection\n* Any pre-treatment laboratory findings within 30 days of treatment demonstrating: alanine aminotransferase level greater than 5 times upper normal limit and\u002For serum bilirubin greater than 2 mg\u002Fdl (\\>34 umol\u002Fl)\n* Current or previously evidence of ascites on CT-scan or physical examination\n* Tumour volume greater than 50% of liver volume\n* Conditions precluding translational samples",{"count":53,"type":20},"Observational, feasibility study investigating biological aspects in patients with liver metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis of biological samples.",[27],[214,215,216],"Liver metastasis Colon Cancer","Circulating Tumour DNA","Selective Internal Radiation Therapy","2026-01-12",{"date":219,"type":36},"2026-01-13",{"date":221,"type":36},"2020-11-01",{"date":223,"type":20},"2028-09-30",{"name":225,"class":43},"Aarhus University Hospital",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":21,"phases":237,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":44},"100453559","ldlt-in-non-resectable-colo-rectal-cancer-liver-metastasis-100453559","NCT05186116","LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis","Living Donor Liver Transplantation (LDLT) in Non Resectable Colo-rectal Cancer Liver Metastasis. The LIVERMORE Trial (LIVing Donor livEr tRansplant Modena cOloRectal mEtastasis) [Original Title in Italian: \"Trapianto di Fegato da Donatore Vivente Per Metastasi Epatiche Non Resecabili da Adenocarcinoma Del Colon\"]","LIVERMORE","Inclusion Criteria:\n\n* Age ≥18.\n* Histologically confirmed colon and rectum (intraperitoneal) adenocarcinoma.\n* Pathological classification of primary tumor as pT1-3, without peritoneal tumor deposits, absence of mucinous component \\>50%, confirmed R0 resection, no limitations for RAS mutations, B-RAF wild type.\n* No signs of extra hepatic metastatic disease or local recurrence according to CT scan+MRI+PET\u002FCT scans.\n* Liver metastases not eligible for curative liver resection\n* Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (complete \\[CR\\] or partial response \\[PR\\] or standard disease \\[SD\\]) during second- line treatment for at least 4 months.\n* Carcinoembryonic Antigen (CEA) values stable or decreasing during the enrollment prior to liver transplant.\n* Performance status, ECOG (Eastern Cooperative Oncology Group) 0-2.\n* Signed informed consent and expected cooperation of the patients for the treatment and follow-up, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Hereditary CRC syndromes including FAP (Familial adenomatous polyposis) and Lynch syndrome.\n* Prior extra hepatic metastatic disease or primary tumor local relapse.\n* Palliative resection of primary CRC tumor.\n* Disease progression\n* Other malignancies in the previous 5 years (with exception of in situ cervical carcinoma and basal cell carcinoma; superficial bladder tumors are allowed if curatively treated).\n* Active intra-venous or alcohol abusers (patients may be eligible if abstention \\> 6 months is demonstrated)\n* Active HIV infection\n* Psychiatric disorders and patient low compliance\n* Any reason why, in the judgment of the investigators, the patient should not participate (to be formally declared)","77 Years",{"count":236,"type":20},25,[23],"This study is an interventional open label prospective study that aims to assess both overall and disease-free survival of patients treated with LDLT, partial or whole graft LT from deceased donors for unresectable CRLM.\n\nSecondary outcomes are graft survival and donor outcomes in terms of safety and quality of life.\n\nDonor selection is performed according to the currently used Institutional and National standards and protocols.",[240,27],"Colon Adenocarcinoma",[242,243,244,245],"LDLT","living donor","CRLM","transplant oncology","2025-09-20",{"date":248,"type":36},"2025-09-25",{"date":250,"type":36},"2022-01-01",{"date":252,"type":20},"2032-01-01",{"name":254,"class":43},"Azienda Ospedaliero-Universitaria di Modena",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":44},"100529886","prospective-cohort-study-on-thermal-ablation-of-malignant-liver-tumors-100529886","NCT06179602","Prospective Cohort Study on Thermal Ablation of Malignant Liver Tumors","Prospective Cohort Study on Thermal Ablation of Malignant Liver Tumors Within the IMAGIO Project (A-IMAGIO)","A-IMAGIO","Inclusion Criteria:\n\n* 18 years or above\n* Candidate for percutaneous thermal liver ablation as discussed in a multidisciplinary tumorboard (MDT)\n* Informed consent\n\nExclusion Criteria:\n\n* Patients lacking capacity to give informed consent.","110 Years",{"count":265,"type":20},1500,"The endpoint of this study is to develop and validate algorithms, using artificial intelligence and machine learning, to optimize patient selection, treatment planning, treatment evaluation and outcome prediction in patients undergoing thermal ablation of a malignant liver tumor. The long-term objective is to establish thermal ablation as the treatment of choice for the vast majority of patients with a primary or secondary liver tumor by development of an accessible workflow that can be widely implemented in different centers performing thermal ablation. Over a time span of at least four years, data will be collected prospectively, encompassing patient information, tumor characteristics, and treatment details. Additionally, pre-, intra-, and post-procedural imaging will be systematically gathered.",[148,59,27,268],"Hepatocellular Carcinoma","2025-09-03",{"date":271,"type":36},"2025-09-10",{"date":273,"type":36},"2024-01-01",{"date":275,"type":20},"2028-01-01",{"name":277,"class":43},"Leiden University Medical Center",{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":21,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":44},"100531517","simultaneous-vs-staged-resection-of-colorectal-cancer-with-synchronous-liver-metastases-100531517","NCT06200831","Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases","Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases - A Multicentre Randomized Controlled Trial","SYLMET","Inclusion Criteria:\n\n* Age 18-80 years old.\n* Both CRC and liver metastases in situ at time of evaluation.\n* Resectable primary tumor in the colon or upper rectum.\n* Less than 5 liver metastases, evaluated by the multidisciplinary tumor board meeting as possible to treat with surgical resection and\u002For ablation (RFA\u002FMWA).\n\nExclusion Criteria:\n\n* Unresectable primary tumor.\n* Locally advanced primary tumor (T4).\n* Primary tumor in the lower rectum with indication for abdominoperineal resection.\n* Acute or imminent bowel obstruction.\n* Perforation or major bleeding from the primary tumor.\n* Pre-treatment of the primary tumor with a colon stent.\n* Liver resection requiring resection of more than 2 adjacent segments (Couinaud).\n* Liver metastases planned treated with irreversible electroporation (IRE).\n* Non-resectable lung metastases.\n* Metastases outside of liver (besides resectable lung metastases).\n* Eastern Cooperative Oncology Group (ECOG) Performance status ≥ 3.","80 Years",{"count":182,"type":20},[23],"The SYLMET Trial is a randomized trial to compare simultaneous and two-staged resection of primary colorectal and synchronous liver metastases. This is an investigator-initiated, multicentre, randomized controlled trial to assess complications (primary endpoint), survival, cost-effectiveness, and quality of life (secondary endpoints).This trial will include patients with resectable primary tumour in the colon or upper rectum with less than five liver metastases that is possible to treat with surgical resection and\u002For ablation (RFA\u002FMWA) at time of evaluation.",[58,291,27,59],"Colorectal Neoplasms Malignant","2025-07-28",{"date":294,"type":36},"2025-07-31",{"date":296,"type":36},"2024-06-01",{"date":298,"type":20},"2031-12-31",{"name":300,"class":43},"Oslo University Hospital",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":263,"enrollmentInfo":309,"targetDuration":311,"studyType":88,"phases":4,"briefSummary":312,"conditions":313,"keywords":318,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":78},"100497317","on-treatment-biomarkers-in-metastatic-colorectal-cancer-for-life-100497317","NCT05755672","On-treatment Biomarkers in Metastatic Colorectal Cancer for Life","On-treatment Biomarkers in Metastatic Colorectal Cancer for Life: The On-CALL Study","On-CALL","Inclusion Criteria:\n\n* Clinical diagnosis of synchronous metastatic colorectal cancer, planned cancer treatment with curative intent at the Skåne University Hospital\n\nExclusion Criteria:\n\n* Not accepting the study inclusion terms (informed consent not obtained)\n* Age below or above the age limit",{"count":310,"type":20},100,"10 Years","By virtue of an increased strategic use of cytotoxic and biological agents, and more options for locoregional treatment, the survival of patients with metastatic colorectal cancer (mCRC) has improved considerably in the past decades. The personalized approach to systemic treatment is further aided by the use of complementary molecular biomarkers. However, the evolutionary dynamics of mCRC, a disease harnessed by multiple adaptive genetic alterations towards its final stages, poses a particular challenge to single-sample biomarker analyses and standardized linear treatment protocols. The aim of the On-treatment biomarkers in metastatic ColorectAL cancer for Life (On-CALL) study is to generate further knowledge on the evolutionary progression of mCRC during treatment, and to elucidate the mechanisms underlying the therapeutic failure still seen in a substantial number of patients.\n\nThe On-CALL study is a prospective, single-arm observational study. All patients diagnosed with synchronous mCRC treated with curative intent at Skåne University Hospital will be invited to participate. Clinical and histopathological data will be compiled at study entry. An individual tissue microarray block with samples from resected primary tumours and metastases representing the full extent of the tumour spread will be constructed for each patient. Blood samples will be drawn for biomarker analyses at multiple time points prior to, during and after systemic treatment. DNA sequencing of tumour tissue and circulating tumour DNA (ctDNA) will be performed to define the spatial clonal landscape in primary tumours and metastases, as well as over time.",[314,315,316,27,317],"Metastatic Colorectal Cancer","Chemotherapy Effect","Peritoneal Metastases","Lung Metastases",[319,320,321,322,323],"Metastatic colorectal cancer","Chemotherapy","Targeted therapy","Tumor heterogeneity","Tumor evolution","2025-07-14",{"date":326,"type":36},"2025-07-17",{"date":328,"type":36},"2023-03-01",{"date":330,"type":20},"2033-03",{"name":332,"class":43},"Region Skane",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":21,"phases":342,"briefSummary":343,"conditions":344,"keywords":345,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":78},"100463415","gadoxetate-abbreviated-mri-in-metastatic-colorectal-cancer-100463415","NCT05314400","Gadoxetate Abbreviated MRI in Metastatic Colorectal Cancer","A Prospective Study Evaluating Diagnostic Accuracy, Outcome, and Economic Impact of Abbreviated Gadoxetate-enhanced MRI of the Liver in Patients With Metastatic Colorectal Carcinoma","Inclusion Criteria:\n\n* Male or female, 18 years of age or older\n* Diagnosis of colorectal cancer, biopsy proven\n* Prior imaging showing liver lesions that may be metastases\n* Provision of signed and dated informed consent form\n* Willingness to comply with study procedures and availability for the duration of the study\n* Able to tolerate MRI required by protocol\n\nExclusion Criteria:\n\n* Presence of implanted medical device or metallic object that is MR incompatible\n* Baseline eGFR of \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n* Severe claustrophobia not relieved by oral anxiolytics\n* Documented severe allergic-like reaction gadolinium-based contrast agent\n* Weight greater than allowable on MRI table\n* Pregnancy\n* Diffuse liver metastases, i.e. definitively unresectable\n* Severe liver dysfunction, ALBI grade 3",{"count":341,"type":20},200,[23],"After a patient is diagnosed with colon cancer, they receive a CT of the chest, abdomen, and pelvis to see if the cancer has spread (metastasized) to other parts of the body. A common site for the cancer to spread to is the liver. If an abnormality is seen in the liver on CT, sometimes an MRI of the liver is required to determine a) whether it is cancer or not and b) whether there are small tumours in the liver that were not visible on CT.\n\nDuring the MRI, the patient is injected with intravenous (IV) contrast. This makes liver lesions more conspicuous and also helps determine if they are cancerous or not. The most commonly used IV contrast agent is called Gadovist. However, there is another IV contrast agent called Primovist that is better at detecting liver metastases from colon cancer than Gadovist. This is very important information for surgeons, because if they considering cutting out (resecting) the liver tumours, they want to make sure they get them all.\n\nUnfortunately, Primovist is used sparingly in Canadian hospitals because it is more expensive than Gadovist and the MRI takes longer. Some early small studies have suggested that it may be possible to shorten the Primovist MRI significantly (e.g. from 60 minutes to 15 minutes), making it economically feasible to offer Primovist to more patients. However, there have not been any large studies performed to confirm these findings.\n\nThe purpose of this study is to compare the accuracy of colon cancer liver metastasis detection between a regular, full-length Primovist MRI versus a shortened Primovist MRI protocol. The economic impact will also be assessed.",[27],[58,346,347,348],"Liver Metastasis","Gadoxetate (Primovist \u002F Eovist)","Abbreviated MRI","2025-07-08",{"date":351,"type":36},"2025-07-11",{"date":353,"type":36},"2022-07-01",{"date":355,"type":20},"2027-10-01",{"name":357,"class":43},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":21,"phases":368,"briefSummary":370,"conditions":371,"keywords":372,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":44},"100564549","phase-1-dose-finding-efficacy-and-immunological-response-of-ip-001-following-mwa-or-ire-for-crlm-100564549","NCT06630624","Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM","INJECTABL-II: Dose Finding, Efficacy and Immunological Response of a Novel Immuno-Adjuvant (IP-001) Following Microwave Ablation or Irreversible Electroporation for Colorectal Liver Metastases.","INJECTABL-II","All phases:\n\nInclusion Criteria:\n\n* Measurable metastatic CRC based on RECIST v1.1;\n* The primary tumor has been resected before study inclusion or the patient is asymptomatic with respect to the in situ primary tumor;\n* Last imaging ≤ 4 weeks prior to the on-study ablative procedure;\n* Age ≥ 18 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status of no more than 1;\n* A life expectancy of at least 3 months at the time of inclusion;\n* Adequate bone marrow, liver, and renal function as assessed by laboratory tests. These results should be judged by the local investigator and should be conducted within 7 days prior to definite inclusion;\n* Written informed consent.\n\nExclusion Criteria:\n\n* Compromised liver function defined as warning signs of portal hypertension, INR \\> 1,5 without use of anticoagulants, bilirubin \\> x 1.5 Upper limit of normal range (ULN) ASAT \\>5.0 x ULN, ALAT \\>5.0 x ULN.\n* Compromised kidney function defined as eGFR \\<45 ml\u002Fmin (using the Cockcroft Gault formula);\n* Active autoimmune disease requiring disease-modifying therapy at the time of screening or during the study period: i.e. \\> 10 mg prednisolone per day or other immunosuppressive therapy (e.g. methotrexate);\n* Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results;\n* Known allergic reaction to shellfish, crabs, crustaceans, or any trial components;\n* Known history of HIV or active Hepatitis C or Hepatitis B infection;\n* Uncontrolled infections (\\> grade 2 NCI-CTC version 3.0); requiring antibiotics;\n* Pregnant or breast-feeding subjects; Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment;\n* Known allergy to contrast agent that cannot be adequately prevented;\n* Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study;\n* Major surgery or radiotherapy ≤ 3 weeks (7 days for single fraction of palliative radiotherapy) prior to the on-study ablative procedure;\n* Systemic therapy ≤ 4 weeks prior to the on-study ablative procedure;\n* CTCAE Grade ≥1 from all side effects of prior therapies or prior procedures at the time of inclusion.\n\nPhase 1\n\nInclusion Criteria:\n\n* Progressive or stable metastatic CRC on CT-scan after at least 1 lines of standard of care systemic treatment. Standard of care systemic treatment will be defined and determined by the treating oncologist. A summary of standard of care systemic treatment for CRLM as used by the medical oncologists at Amsterdam UMC has been listed in Table 1. Patients can also be included if systemic treatment has to be terminated due to toxicity or when patients refuse (further) systemic treatment, or when patients are in a therapy break from systemic therapy as patients can continue with further systemic treatment one month after the study treatment;\n* At least 2 CRLM eligible for MWA with a minimum diameter of 1cm and a maximum diameter of 3cm and one (optional but not required) CRLM that will be left untreated and is eligible for biopsy;\n* No limitations on intrahepatic or extrahepatic disease;\n\nExclusion Criteria:\n\n\\- No additional exclusion criteria.\n\nPhase 2 part 1:\n\nInclusion Criteria:\n\n* At least one CRLM and a maximum of three CRLM size ≤ 3 cm eligible for MWA with curative intent;\n* Additional unablatable CRLM should be resectable with a maximum of 10 additional CRLM;\n* Resectability and ablatability should be re-confirmed intra-operatively by US in case of combined\u002Fstaged resection and ablation. Intra-operatively also full exploration for hepatic, peritoneal and regional lymph node metastases should be performed;\n\nExclusion Criteria:\n\n* Radical treatment unfeasible or unsafe (e.g. insufficient FLR);\n* The presence of extrahepatic nodal or non-nodal metastases. One locally treatable lung metastasis is allowed;\n* Any surgical resection or focal ablative liver therapy for CRLM prior to inclusion;\n\nPhase 2 part 2:\n\nInclusion Criteria:\n\n* Liver only or liver dominant measurable metastatic CRC based on RECIST v1.1;\n* Liver dominant metastatic disease is defined as the hepatic tumorload (number and estimated volume) exceeding the extrahepatic tumorload, with a maximum of 5 unequivocal extrahepatic metastases in ≤2 different organ systems;\n* At least 2 CRLM, of which at least one is eligible for the study treatment (RFA, MWA and IRE);\n* At least 50% (number and estimated volume) of the CRLM should be eligible for ablation. A maximum of 4 CRLM can be assigned for the study treatment. One CRLM has to be left untreated;\n* At least one untreated CRLM and one 'to-be-treated' CRLM should be eligible for biopsy;\n* Maximum size of CRLM for study treatment is 3cm;\n* Any CRLM with a maximum lesion size of 5cm at time of inclusion;\n* Limited extrahepatic disease, restricted to the lungs and lymph nodes, with a maximum lesion size of 3cm at time of inclusion. See below for additional information regarding pulmonary nodules;\n* Progressive disease on CT-scan after standard of care systemic treatment. Standard of care systemic treatment will be defined and determined by the treating oncologist. Patients can also be included if systemic treatment has to be terminated due to toxicity or when patients refuse (further) systemic treatment.;\n\nExclusion Criteria:\n\n* Tumor diameter of ≥ 5 cm of any hepatic lesion at the time of inclusion. If lesion size exceeds 5 cm at start of the procedure, the patient will not be excluded;\n* Metastases in the lungs or lymph nodes ≥ 3 cm. If lesion size exceeds 3 cm at start of the procedure, the patient will not be excluded;\n* Metastases in any other organ than the liver, lungs of lymph nodes;",{"count":367,"type":20},120,[369,55],"PHASE1","The primary objectives of this phase I\u002FII, prospective clinical trial, are to assess the optimal dose, efficacy, safety and immunological effect of ablation and intra-tumoral injection of a novel immuno-adjuvant (IP-001) for colorectal liver metastases (CRLM). The study consists of three parts, devided into two phases.\n\nPhase 1 is a dose-escalation study according to a classic '3+3' design, to identify the dose level at which IP-001 exhibits an acceptable level of toxicity following microwave ablation (MWA) of CRLM in refractory metastatic colorectal cancer (CRC) patients.\n\nPhase 2, part 1 and part 2 are performed simultaneously. In phase 2 part 1, a single arm study assesses the efficacy of IP-001 following MWA for CRLM for curative intent. In phase 2 part 2, a randomized, two-armed study assesses the efficacy and immunomodulation of IP-001 following two ablative modalities: arm A (MWA) and arm C (irreversible electroporation (IRE)) for CRLM in refractory metastatic CRC patients.",[58,59,27],[373,374,375,376,377],"Colorectal liver metastases","Colorectal hepatic metastases","irreversible electroporation","Microwave ablation","Immunotherapy","2025-06-30",{"date":380,"type":36},"2025-07-03",{"date":382,"type":36},"2024-07-10",{"date":384,"type":20},"2031-08-01",{"name":386,"class":43},"M.R. Meijerink",{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":21,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":44},"100498814","phase-2-sbrt-of-metastases-following-neo-adjuvant-treatment-for-colorectal-cancer-with-synchronous-liver-metastases-100498814","NCT05775146","SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases","Phase II Single Arm Feasibility Trial to Evaluate Stereotactic Ablative Radiation of Metastases for the Management of Colorectal Cancer With Synchronous Oligo-metastases in Liver","Inclusion Criteria:\n\n* Age ≥ 18 years\n* ECOG (Eastern Cooperative Oncology Group) 0-2\n* Able to provide written informed consent\n* 1-5 Liver lesions with max size of ≤5cm for a single lesion and restricted to one lobe of liver; deemed at Multi-Disciplinary Tumor Board (MDT) to be potentially amenable for SBRT with curative intent\n* Liver lesion identified within 3 months of diagnosis of primary and deemed at Multi-Disciplinary Tumor Board (MDT) to be potentially amenable for SBRT with curative intent\n* Plan for resection of primary with curative intent\n* Patients with liver metastases and potentially resectable\u002Fablatable lung mets can be included.\n* Colon cancer patients who have undergone upfront resection of primary colonic lesion can be included\n* Able and willing to comply with the terms of the protocol including health-related quality of life (HRQoL) questionnaires\n* Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \\> 40 mIU\u002FmL to confirm menopause.\n* Females must not be breastfeeding\n* Male patients should agree to not donate sperm during the study\n\nExclusion Criteria:\n\n* Extra-hepatic metastases (except potentially resectable lung mets)\n* Not a suitable candidate for liver resection surgery\n* Not a suitable candidate for SBRT\n* Past history of cancer within 5 years (except basal cell carcinoma)\n* Patients who have undergone previous surgery or ablation for liver lesions\n* Planned simultaneous resection of primary and liver metastases\n* Pregnancy\n* Patients with Child-Pugh C and documented cirrhosis",{"count":5,"type":20},[55],"The purpose of this study is to prospectively evaluate the feasibility of SBRT for the management of synchronous oligo metastatic liver metastases from colorectal cancers.",[58,27],"2025-06-24",{"date":400,"type":36},"2025-06-27",{"date":402,"type":36},"2024-06-18",{"date":404,"type":20},"2028-06-30",{"name":406,"class":43},"AHS Cancer Control Alberta",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":16,"minAge":415,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":21,"phases":419,"briefSummary":420,"conditions":421,"keywords":422,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":4},"100587958","phase-1-detecting-colorectal-cancer-with-liver-metastatic-lesions-using-novel-precise-imaging-tools-100587958","NCT06935149","Detecting Colorectal Cancer With Liver Metastatic Lesions Using Novel Precise Imaging Tools","Detecting Liver Metastatic Lesions in Patients of Colorectal Cancer With Novel Precise Imaging Tools","PSMA","Main inclusion criteria:\n\n1. The participants can voluntarily sign informed consent forms\n2. The participants are male\u002Ffemale over 20 years old.\n3. The participant is currently undergoing cancer staging based on the previous pathological diagnosis of colorectal cancer\n4. The participants are confirmed liver metastasis by CT, abdominal ultrasound, MRI, and FDG PET\u002FCT within 30 days before receiving PSMA-PET\u002FCT.\n5. WHO performance status ≦ 2 points\n6. The participants can lie on table for two hours during PSMA-PET\u002FCT scanning.\n\nMain exclusion criteria: To improve the accurate interpretation of PMSA-PET imaging and reduce the occurrence of related-drug adverse events, the participants will be excluded by following below criteria.\n\n1. The colorectal cancer participants was diagnosed other organs metastases with multiple organ metastases not only the liver.\n2. The colorectal cancer participants have undergone any treate after diagnosis of liver metastasis.\n3. The participants have suffered from liver dysfunction such as AST\u002FALT ratio \\>2、total bilirubin \\>1.5 mg\u002FdL within 6 months.\n4. The participants suffered stage IV chronic kidney disease (eGFR\\\u003C30 mL\u002Fmin\u002F1.73 m2) within 6 months.\n5. The participants suffered acute kidney injury within 6 months.\n6. The participants suffered trauma or fracture.\n7. The participants are allergic to any radiopharmaceutical or imaging agent.\n8. The participants are history of claustrophobia or are inability to remain quiet during the examination.","20 Years","100 Years",{"count":418,"type":20},5,[369],"This study will demonstrate the diagnostic utility of PSMA PET among patients with CRC with liver metastasis.",[27],[423,413,424],"Liver metastasis","PET","2025-04-18",{"date":427,"type":36},"2025-04-24",{"date":429,"type":20},"2025-05-01",{"date":431,"type":20},"2025-12-31",{"name":433,"class":434},"Primo Biotechnology Co., Ltd","INDUSTRY",{"id":436,"slug":437,"hasResults":11,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":286,"enrollmentInfo":443,"targetDuration":4,"studyType":21,"phases":445,"briefSummary":446,"conditions":447,"keywords":449,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":44},"100519949","tango-liver-three-arm-nuclear-growth-observation-in-liver-surgery-100519949","NCT06050200","TANGO-LIVER Three Arm Nuclear Growth Observation in Liver Surgery","Comparison of Three Methods of Inducing Liver Hypertrophy Before Resection - a Randomized Controlled Trial","TANGO-LIVER","Inclusion Criteria:\n\n* age \\>= 18 years\n* patients qualified for liver resection\n* future remnant liver \\\u003C30% of standard liver volume\n* written informed consent\n\nExclusion Criteria:\n\n* liver cirrhosis\n* pregnancy\n* poor general health status or comorbidities excluding general anesthesia or hepatic resection\n* contraindications to iodine contrast agents",{"count":444,"type":20},154,[23],"Liver resection is the treatment of choice in patients with malignant liver lesions. Unfortunately, the surgery is not always an option, as in same patients the future remnant liver (FRL) is too small to supply all the functions. Therefore, some additional methods have been proposed to increase the size of the FRL.\n\nThe aim of this study is to compare the efficacy and safety of three methods of increasing the future remnant liver - Portal Vein Embolization (PVE) - embolization of one of the portal branches; Liver Vein Deprivation (LVD) - embolization both of the portal branch as well as the hepatic vein; and partial ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy) - ligation of portal vein branch with partial liver transection.\n\nThe efficacy of those three methods will be assessed both by analyzing the volumetric increase (by computer tomography scans) and by functional increase (by 99mTc-mebrofenin scintigraphy). Functional assessment of the liver hypertrophy seems to be of crucial importance, as some of the previous studies suggest that there might be a significant discrepancy in the increase of size comparing to the increase of function.\n\nThis is a prospective, interventional randomized study. The study group (154 patients) will consist of patients being considered as candidates for major hepatic resection, after inducing hypertrophy of the future remnant liver.\n\nThe primary study hypothesis is greater efficacy of ALPPS in preparing patients for large hepatic resection by inducing hypertrophy of the future remnant liver, as compared both to PVE and LVD.\n\nIn case of unsuccessful induction of hypertrophy by the embolization techniques, patients may be qualified to rescue ALPPS procedure.\n\nPrimary end-point:\n\nPercentage of patients with successful resection (patients, who gained sufficient increase of the FRL to proceed to the liver resection) with no post-surgical 90-day mortality.\n\nSecondary end-points:\n\n1. the rate and degree of volume increase in different groups\n2. the rate and degree of functional increase in different groups\n3. CCI index and complication rate \\>=3 degree according to the Clavien-Dindo classification after the first stage of treatment\n4. CCI index and complication rate \\>=3 degree according to the Clavien-Dindo classification after the second stage of treatment\n5. overall duration of hospital stay\n\nPatient will be randomly assigned to the three study groups. All patients will undergo an abdominal contrast enhanced computed tomography and 99mTc-mebrofenin scintigraphy prior to the first stage of treatment. During the first stage of treatment, patients will undergo, according to their group:\n\n1. Embolization of portal vein branch (PVE, portal vein embolization)\n2. Embolization of both portal vein branch and hepatic vein (LVD, liver venous deprivation)\n3. Partial ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy) - ligation of portal vein branch with partial liver transection, preferentially by laparoscopic technique Computed tomography scans and scintigraphy will be repeated at day 7, 14 and 21 after the first stage of treatment. The second stage of treatment, the liver resection, will be performed after achievement of sufficient mebrofenin clearance rate (\\>=2,69%\u002Fmin\u002Fm2). In case of failure to reach the desired clearance rate, the measurements will be continued every 7 days up to day 42. In case of uncertainty and discrepancy between the volumetric assessment in the computed tomography scan and the mebrofenin scintigraphy, it will be allowed to proceed to stage two (partial hepatectomy) after joint consultation of at least 3 hepatobiliary surgeons, 1 radiologist and 1 nuclear medicine specialist. Routine blood tests will be performed according to the standard procedure in the Department, depending on the patient clinical status. An additional blood sample will be collected from patients (after receiving and additional informed consent from the patient) and will be stored in the biobank.\n\nAll patients will be monitored for surgical and 90-day complications. The volume increase after first stage of treatment, the functional increase after first stage of treatment, percentage of patients successfully proceeding to the second stage of treatment and complication rate will be calculated.\n\nThe percentage of patients with complications \\>= 3 degree in Clavien-Dindo classification and CCI index for each patient will be calculated.\n\nFurthermore, the blood test results will be assessed to search for associations with patients' outcomes. Any possible differences in terms of baseline patients characteristics between groups will be addressed.\n\nStatistical analysis will be performed using U Mann-Whitney test, exact Fisher's test, logistic regression, general linear models, Kaplan-Meier method and log-rank test. All three groups will be assessed in terms of occurrence of primary and secondary end-points.",[59,148,448,27],"Liver Neoplasms",[450,451,452,453,454,455,456,457,458,459,460,461],"liver metastases","liver cancer","liver neoplasms","portal vein embolisation","liver venous deprivation","PVE","LVD","Associating Liver Partition and Portal vein Ligation for Staged hepatectomy","ALPPS","liver resection","mebrofenin scintigraphy","liver surgery","2025-03-26",{"date":464,"type":36},"2025-04-01",{"date":466,"type":36},"2024-08-28",{"date":468,"type":20},"2029-05",{"name":470,"class":43},"Medical University of Warsaw",{"id":472,"slug":473,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":141,"enrollmentInfo":478,"targetDuration":4,"studyType":21,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":44},"100423824","improving-survival-of-colorectal-liver-metastases-by-rfa-mediated-immunostimulation-100423824","NCT04798898","Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation","ISCOLIM","Inclusion Criteria:\n\n* Patients with colorectal liver metastases planned for resection\n* At least one tumor size \\>=3cm\n* Performance status 0-1\n\nExclusion Criteria:\n\n* Liver cirrhosis\n* Extrahepatic metastases that can not be addressed curatively\n* Other malignant diseases within 5 years prior to diagnosis\n* Prior RFA treatment",{"count":341,"type":20},[23],"To examine radio frequency ablation as a treatment supplement to stimulate immunogenicity and improve survival for patients undergoing curative-intent surgery for colorectal liver metastases.",[27],"2024-12-04",{"date":484,"type":36},"2024-12-05",{"date":486,"type":36},"2022-11-14",{"date":488,"type":20},"2026-12-01",{"name":490,"class":43},"University of Aarhus",{"id":492,"slug":493,"hasResults":11,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":21,"phases":500,"briefSummary":501,"conditions":502,"keywords":505,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":44},"100525798","application-of-high-dose-insulin-therapy-to-improve-liver-function-and-regeneration-100525798","NCT06126419","Application of High-dose Insulin Therapy to Improve Liver Function and Regeneration","Application of High-Dose Insulin Therapy Using a Hyperinsulinemic Normoglycemic Clamp to Improve Liver Function and Regeneration","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Candidate for major liver resection\n* Resectable colorectal liver metastasis\n\nExclusion Criteria:\n\n* Inability to give consent\n* Type 1 diabetes mellitus\n* Uncontrolled blood glucose levels (fasting level \\> 10 mmol\u002FL)\n* Unresectable colorectal liver metastasis\n* Extrahepatic metastatic disease that is unresectable",{"count":499,"type":20},70,[23],"The primary objective of this interventional study is determine if the future liver remnant can be optimized by improving liver function pre-operatively in patients who are scheduled for major hepatectomy. The main questions it aims to answer are:\n\n1. Does high-dose insulin therapy improve liver function in the pre-operative setting?\n2. What is the effect of high-dose insulin therapy on liver function and liver regeneration after a liver venous deprivation (LVD) procedure?\n3. What is the relationship between volume hypertrophy and function in the regenerating liver? Participants will receive a 6-hour infusion of insulin and dextrose to maintain a hyperinsulinemic-normoglycemic state in the weeks prior to planned liver surgery to assess its effect on liver function measured by 99m-Tc-Mebrofenin hepatobiliary scintigraphy.",[503,27,504],"Liver Dysfunction","Liver Regeneration",[506,507,508,509,510],"Hyperinsulinemic-Normoglycemic Clamp","High Dose Insulin Therapy","99mTc-Mebrofenin Hepatobiliary Scintigraphy","Colorectal Cancer Liver Metastasis","Liver Resection","2024-11-18",{"date":513,"type":36},"2024-11-20",{"date":515,"type":36},"2023-11-08",{"date":517,"type":20},"2026-12",{"name":519,"class":43},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":521,"slug":522,"hasResults":11,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":21,"phases":530,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":44},"100530344","phase-2-coldfire-iii-trial-efficacy-of-irreversible-electroporation-and-stereotactic-body-radiotherapy-for-perivascular-and-peribiliary-colorectal-liver-metastases-100530344","NCT06185556","COLDFIRE-III Trial: Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases","COLDFIRE-III Trial: Perivascular and Peribiliary Colorectal Liver Metastases (0-5cm): Irreversible Electroporation Versus Stereotactic Body Radiotherapy","COLDFIRE-III","Inclusion Criteria:\n\n* Histological documentation of primary colorectal tumor is available;\n* 1-3 CRLM visible on ceCT and\u002For MRI, size 0-5 cm and not eligible for resection or thermal ablation due to location close to a vessel or bile duct;\n* Additional CRLM are allowed if considered either resectable or ablatable with a maximum of 10 CRLM. In patients with extrahepatic disease, a maximum of 5 additional CRLM is allowed;\n* No or limited extrahepatic disease (1 extrahepatic lesion is allowed, with some exclusions mentioned in the exclusion criteria);\n* Prior focal liver treatment is allowed;\n* Subjects should preferably be treated with neo-adjuvant systemic therapy;\n* Subjects with recurrent (either local or distant-hepatic) CRLM after previous focal treatment who are unsuitable for (further) systemic therapy (further downsizing or conversion to resectable disease improbable);\n* Adequate bone marrow, liver and renal function as assessed by laboratory requirements to be conducted within 7 days prior to definite inclusion;\n* ASA classification 0 - 3;\n* Age \\>18 years;\n* Written informed consent;\n\nExclusion Criteria:\n\n* Radical treatment unfeasible or unsafe (e.g. insufficient FLR);\n* \\>10 CRLM; \\>5 CRLM when extra-hepatic disease is present;\n* Positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis;\n* Subjects who have progressive disease after neo-adjuvant systemic therapy;\n* History of epilepsy;\n* History of cardiac disease:\n* Uncontrolled hypertension. Blood pressure must be ≤160\u002F95 mmHg at the time of screening on a stable antihypertensive regimen;\n* Compromised liver function (e.g. signs of portal hypertension, INR \\> 1,5 without use of anticoagulants, ascites);\n* Pregnant or breast-feeding subjects;\n* Immunotherapy ≤ 2 weeks prior to the procedure;\n* Chemotherapy and\u002For targeted therapy ≤ 2 weeks prior to the procedure;\n* Severe allergy to contrast media not controlled with premedication;\n* Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.",{"count":529,"type":20},78,[55,531],"PHASE3","The primary objective of this phase IIb\u002FIII, prospective, randomized clinical trial is to compare the efficacy of irreversible electroporation (IRE) with stereotactic body radiotherapy (SBRT) in patients with perivascular or peribiliary colorectal liver metastases (CRLM), that are not amenable for surgical resection or thermal ablation. Efficacy is assessed in terms of local control at 2 years.",[58,59,27,534],"Unresectable Solid Tumor",[373,536],"colorectal hepatic metastases","2024-08-21",{"date":539,"type":36},"2024-08-23",{"date":541,"type":36},"2024-08-20",{"date":543,"type":20},"2031-09-01",{"name":545,"class":43},"Amsterdam UMC, location VUmc",{"id":547,"slug":548,"hasResults":11,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":11,"sex":16,"minAge":553,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":21,"phases":556,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":4},"100519704","phase-1-irreversible-electroporation-nanoknife--and-immunotherapy-for-the-treatment-of-stage-iv-colorectal-cancer-100519704","NCT06047015","Irreversible Electroporation (NanoKnife ®) and Immunotherapy for the Treatment of Stage IV Colorectal Cancer","Immune Response to Irreversible Electroporation (NanoKnife ®) and a Checkpoint Inhibitor With or Without CpG Oligodeoxynucleotides for the Treatment of Stage IV Colorectal Cancer","Inclusion Criteria:\n\n1. Biopsy-proven colorectal liver metastases with at least one measuring \\\u003C 3.5 cm in diameter and accessible to percutaneous IRE such that a complete ablation of the lesion is possible.\n2. Prior resection of the colorectal cancer primary.\n3. The imaging has been reviewed in multi-disciplinary Rounds and the colorectal liver metastases have been deemed unresectable.\n4. Patient has undergone chemotherapy and has not converted to resectable disease.\n5. Radiologic evidence of stable disease for at least two months on systemic therapy for colorectal cancer (may have had prior partial response or disease progression)\n6. Microsattelite instability (MSI)-stable or mismatch-proficient tumors\n7. Patient has HLA phenotype of Human Leukocyte Antigen (HLA) A1 or HLA A2.\n8. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Size of the metastasis being treated with IRE \\> 3.2 cm or \\\u003C 2 cm.\n2. Size of any non-IRE-treated liver metastasis \\> 4 cm\n3. Pregnancy\n4. Major comorbid disease\n5. Active autoimmune disease\n6. Bone or brain or peritoneal metastases.\n7. MSI High disease\n8. Patients with cardiac arrhythmia other than rate controlled atrial fibrillation.\n9. Metal implant that cannot be removed within 10 cm of the area to be treated.\n10. Peritoneal disease.\n11. Poor performance status\n12. Cirrhosis","16 Years",{"count":555,"type":20},12,[369,55],"The goal of this pilot clinical trial is to learn about the combination of immune boosting drugs and irreversible electroporation (IRE) in patients with colon cancer that has spread to the liver (metastasis). The main questions it aims to answer are:\n\n1. to document the rate of complications associated with combining IRE with immune boosting drugs.\n2. After one liver metastasis is treated with IRE and immune boosting drugs, what is the change in the size of the non-IRE-treated liver metastases?\n3. What is the immune response (measured in a blood sample) when IRE is combined with one or two types of immune boosting drugs?",[27],"2024-08-06",{"date":561,"type":36},"2024-08-09",{"date":563,"type":20},"2025-07",{"date":565,"type":20},"2028-12",{"name":567,"class":43},"University of Saskatchewan",{"id":569,"slug":570,"hasResults":11,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":577,"conditions":578,"keywords":581,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":44},"100361080","microwave-ablation-for-treatment-of-small-renal-tumors-and-primary-and-secondary-liver-neoplasms-100361080","NCT03981497","Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms","Retrospective and Perspective Analysis of Short, Medium and Long Term Clinical Performance of Patients Undergoing MicrowaveThermal Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms","Inclusion Criteria:\n\n* \\> 18 years with primary or secondary liver tumors or small kidney tumors that are not candidates for surgery or cannot be radically resected by surgery alone\n* Primary liver cancer: up to three liver nodules ≤ 3 cm\n* Secondary hepatic tumours: up to nodules ≤ 3 cm provided that the objective is complete hepatic clearance Renal tumours: single or multiple (von Hippel Lindau syndrome), \\\u003C 4 cm\n\nExclusion Criteria:\n\n* pregnant women\n* non-manageable coagulopathies\n* Extended extrahepatic or extrarenal disease\n* for liver ablation: presence of bilio-digestive anastomosis",{"count":576,"type":20},500,"The goal of this observational study is to collect data on efficacy and safety of microwave ablation (MWA) used to treat subjects with primary and secondary liver malignancies and renal malignancies. The main question it aims to evaluate the short, medium and long-term clinical course of patients treated with MWA.\n\nParticipants will not alter their normal clinical and therapeutic practice, due to the observational nature of the study, and all data regarding microwave treatments will be collected (including demographic data). follow their normal clinical and therapeutic path",[148,27,579,580],"Kidney Cancer","Renal Cell Carcinoma",[582],"MWA","2024-04-11",{"date":585,"type":36},"2024-04-12",{"date":587,"type":36},"2018-02-28",{"date":589,"type":20},"2030-12-31",{"name":591,"class":43},"Francesco De Cobelli",{"id":593,"slug":594,"hasResults":11,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":21,"phases":602,"briefSummary":603,"conditions":604,"keywords":606,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":44},"100520240","hepatopulmonary-radio-sterilization-with-immunotherapy-100520240","NCT06053996","Hepatopulmonary Radio-sterilization With Immunotherapy","Hepatopulmonary Radio-sterilization Combined With Checkpoint Inhibition, a Proof-of-concept Phase II Clinical Trial in Colorectal Cancer","TROS-8","Inclusion Criteria:\n\nDisease factors\n\n* Histologically- or cytologically-confirmed diagnosis of colorectal cancer (CRC).\n* Metastatic or recurrent CRC, deemed surgically or medically unresectable.\n* Subjects who are candidates to receive immunotherapy, whether MSS or MSI-high.\n* Subjects who have liver and \u002F or lung metastases amenable to SBRT.\n\nGeneral considerations\n\n* Age ≥18 years.\n* ECOG performance status ≤1 (Karnofsky ≥70%, see Appendix A).\n* Life expectancy of ≥ 3 months\n* Patients must have normal organ and marrow function as defined below:\n* absolute neutrophil count ≥1,500\u002FmcL\n* platelets ≥100,000\u002FmcL\n* hemoglobin ≥ 9.0 g\u002FdL\n* total bilirubin ≤ 1.5 x ULN except subjects with Gilbert Syndrome must have a total bilirubin level \\\u003C 3.0 mg\u002FdL).\n* AST(SGOT)\u002FALT(SGPT) ≤2.0 × institutional upper limit of normal\n* creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 mL\u002Fmin (using the Cockcroft Gault formula)\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of treatment.\n* Signed Written Informed Consent\n* Subjects must have signed and dated an IRB approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.\n* Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.\n\nExclusion Criteria:\n\n\\- Disease factors \u002F Tumor characteristics\n\n• Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.\n\nPrevious treatments and trials\n\n* Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 3 weeks of the first dose of treatment.\n* Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has had prior chemotherapy, targeted small molecule therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.\n* If subject received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n\nComorbidities, medications and immune modulation agents\n\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.\n* Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with type I diabetes mellitus, 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. Subjects that require intermittent use of bronchodilators or local steroids, e.g., inhaled or topical steroids, at a dose of less than the equivalent of 10mg prednisone daily, would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.\n* Has evidence of interstitial lung disease or active, non-infectious pneumonitis.\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* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\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 a diagnosis of 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* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies).\n* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Has received a live vaccine within 30 days prior to the first dose of trial treatment.\n* Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.\n* History of allergy or hypersensitivity to any study drug components, to compounds of similar chemical or biologic composition\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":601,"type":20},44,[23],"In this protocol the investigators aim to overcome hepatic-pulmonary metastases-induced resistance to immunotherapy through high dose radiation therapy (SBRT) targeted to the metastases themselves, aiming, when possible, to ablate all macroscopic disease in these organs.",[186,27,605],"Rectal Cancer",[607,608,609,610,611],"radiation","radiotherapy","SBRT","immunotherapy","Stereotactic ablative radiotherapy (SABR)","2023-09-21",{"date":614,"type":36},"2023-09-26",{"date":616,"type":20},"2023-11-01",{"date":618,"type":20},"2028-08-30",{"name":620,"class":621},"Sheba Medical Center","OTHER_GOV",{"id":623,"slug":624,"hasResults":11,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":21,"phases":631,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":44},"100505447","phase-3-collision-relapse-trial-100505447","NCT05861505","COLLISION RELAPSE Trial","COLLISION RELAPSE Trial - Recurrent Colorectal Liver Metastases: Repeat Local Treatment +\u002F- Neoadjuvant Systemic Therapy - a Phase III Prospective Randomized Controlled Trial","Inclusion criteria\n\n* Age \\>18 years\n* Good performance status (ECOG 0-2 \u002F\u002F ASA 1-3)\n* Histological documentation of primary colorectal tumor\n* Local treatment performed for initial CRLM\n* New recurrence ≤12 months\n* ≥1 locally treatable CRLM (resectable\\* and\u002For ablatable)\n* Total number of new CRLM ≤5\n* Chemo-naïve or history of response to CAPOX\u002FFOLFOX\u002FFOLRIRI\n* Life expectancy of at least 12 weeks\n* Adequate bone marrow, liver and renal function\n* Written informed consent Exclusion criteria\n* Extrahepatic disease\n* MSI\u002FdMMR\n* Radical local treatment unfeasible or unsafe (e.g. insufficient future liver volume)\n* Compromised liver function (e.g. signs of portal hypertension, INR \\> 1,5 without use of anticoagulants, ascites)\n* Uncontrolled infections (\\> grade 2 NCI-CTC version 3.0)\n* Pregnant or breast-feeding subjects\n* Immuno- or chemotherapy ≤ 6 weeks prior to the randomization\n* Severe allergy to contrast media not controlled with premedication\n* Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results\n\nECOG = Eastern Cooperative Oncology Group, ASA = American Society of Anesthesiologists, MSI = Microsatellite instability, dMMR = deficient mismatch repair\n\n\\* Resection for resectable lesions considered possible obtaining negative resection margins (R0) and preserving adequate liver reserve",{"count":630,"type":20},360,[531],"The primary objective is to demonstrate superiority of neoadjuvant systemic therapy followed by repeat local treatment as compared to upfront repeat local treatment in patients with at least one locally treatable recurrent CRLM in the absence of extrahepatic disease.",[58,59,27,315,634,635],"Surgery","Recurrence","2023-05-05",{"date":638,"type":36},"2023-05-17",{"date":640,"type":36},"2023-04-24",{"date":642,"type":20},"2028-05-01",{"name":545,"class":43},{"id":645,"slug":646,"hasResults":11,"nctId":647,"briefTitle":648,"officialTitle":648,"acronym":4,"eligibilityCriteria":649,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":650,"enrollmentInfo":651,"targetDuration":4,"studyType":21,"phases":653,"briefSummary":654,"conditions":655,"keywords":656,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":44},"100453492","liver-transplantation-for-non-resectable-colorectal-liver-metastasis-100453492","NCT05185245","Liver Transplantation for Non-Resectable Colorectal Liver Metastasis","Inclusion Criteria:\n\n* Primary tumor resected according to standard oncological practice, p≤T4a, R0 resection\n* Colorectal liver metastasis considered as non-resectable either up-front or after previous hepatic resections\n* No local recurrence of primary colon cancer confirmed by Positron Emission Tomography, Computed Tomography and colonoscopy\n* No extra-hepatic metastatic disease confirmed by Positron Emission Tomography and Computed Tomography\n* Good performance status Eastern Cooperative Oncology Group 0 or 1\n* Neutrophils \\> 1.000\n* Patients who received at least one line of chemotherapy for at least 3 months with partial response or stable disease according to modified Response Evaluation Criteria in Solid Tumours\n* Carcino-Embryonic Antigen \\\u003C 80 µg\u002FL or reduction of ≥ 50% of highest Carcino-Embryonic Antigen level observed\n* Written informed consent\n* No other contraindications to liver transplantation\n\nExclusion Criteria:\n\n* Presence of other malignancies\n* Local recurrence of primary tumor\n* Extra-hepatic metastatic disease\n* Patients who did not receive any neoadjuvant or adjuvant therapy\n* Palliative resection of primary tumor\n* Any other reason, according to the investigators, that could be a contraindication to protocol enrollment","73 Years",{"count":652,"type":20},20,[23],"The study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival.\n\nPatients included in this protocol will be evaluated either for whole or partial liver transplantation from deceased or living donors.\n\nType of different transplantations proposed are as follows:\n\n1. Whole liver graft or partial liver (split) from a deceased donor\n2. Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient.\n3. Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed.\n4. Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy.\n5. Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient.\n6. Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed.\n\nIn cases 2-3-5-6 total hepatectomy of native liver can be secondarily performed after having achieved a proper graft hypertrophy in order to avoid a small for size syndrome",[27,58],[657,658],"liver transplantation","non-resectable colorectal liver metastasis","2022-01-07",{"date":661,"type":36},"2022-01-11",{"date":663,"type":36},"2021-04-01",{"date":665,"type":20},"2030-03-30",{"name":667,"class":43},"IRCCS Azienda Ospedaliero-Universitaria di Bologna"]