[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colon-cancer-liver-metastases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colon-cancer-liver-metastases":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,95,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100569738","colorectal-metastasis-to-liver-extraction-with-auxiliary-transplant-and-delayed-resection-100569738",false,"NCT06698146","Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection","Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection Registry Study","CLEAR","Inclusion:\n\n1. All Patients of either gender ≥ 18 years of age who are listed for Liver transplant candidates at Northwestern with liver metastases due to colorectal cancer (CRLM).\n2. Subjects must be able to provide informed consent themselves and without the use of a legally authorized representative (LAR), to be determined by the PI or Sub-I at the time of Consent.\n\nExclusion:\n\n1. Adults unable to consent\n2. Pregnant Women\n3. Certain clinical\u002Fsurgical\u002Fanatomical parameters, at the discretion of the PI.","ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","10 Years","OBSERVATIONAL","Liver transplantation (LT) has become an accepted treatment for selected patients with unresectable liver metastases due to colorectal cancer (CRLM). The goal of this study is to look at and compare the clinical results of all the different approved methods (living vs. Deceased, whole organ vs. Split, one staged vs. Two staged) used to perform a standard liver transplant procedure for recipients with CRLM. Investigators will look at things like different procedure results, recovery in the hospital, and survival rates one year after the transplant. Investigators will also take blood samples from participants to be used in future research. All the transplant methods the investigators are comparing are standard practices approved by the United Network of Organ Sharing (UNOS).",[26,27,28],"Liver Transplant Surgery","Colorectal Cancer Metastatic","Colon Cancer Liver Metastases",[30,27,31],"Liver Transplant","Colorectal Cancer","RECRUITING","2026-02-06",{"date":35,"type":36},"2026-02-10","ACTUAL",{"date":38,"type":36},"2025-08-27",{"date":40,"type":21},"2035-01-01",{"name":42,"class":43},"Northwestern University","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100617686","phase-2-injection-of-ip-001-into-thermally-ablated-hepatic-tumors-in-patients-with-colorectal-liver-metastases-100617686","NCT07321847","Injection of IP-001 Into Thermally Ablated Hepatic Tumors in Patients With Colorectal Liver Metastases","Intratumoral Injection of IP-001 Following Standard-of-care Complete Hepatic Tumor Ablation in Patients With Liver-only Metastatic Colorectal Cancer","INJECTABL-3","Inclusion Criteria:\n\n1. Patients ≥ 18 y of age at the time of signing the Informed Consent Form in accordance with local regulatory and\u002For national laws and International Council for Harmonisation (ICH)\u002FGood Clinical Practice (GCP) regulations (consent must be received before any study-specific activity is performed).\n2. Patients with liver-only metastatic CRC (and no radiologic or clinical evidence of extrahepatic metastases) with:\n\n   1. No more than 5 CRLM (≤ 3 cm for largest diameter)\n   2. An indication to receive percutaneous or laparoscopic SOC complete CRLM ablation with the intent of leaving no detectable liver disease\n   3. Tumors amenable to ablation treatment in a single session\n   4. No residual primary colorectal tumor at Treatment Day 1 or plans to have the primary tumor excised within 4-12 weeks following Treatment Day 1. (Patients with rectal cancer who underwent chemoradiotherapy for the primary cancer must have a complete clinical response.)\n3. Prior systemic anticancer treatment for metastatic colorectal cancer is permitted but not required. Patients must have received no more than two prior lines of systemic anticancer treatment for mCRC.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 2.\n5. Patients with adequate hematological function (defined as an absolute neutrophil count ≥ 1.5 × 109\u002FL, hemoglobin level ≥ 9 g\u002FdL, and platelet count ≥ 50 × 109\u002FL) and coagulation function (defined as a partial thromboplastin time \\[PTT\\] or activated PTT \\[aPTT\\] and international normalized ratio \\[INR\\] ≤ 1.5 × the upper limit of normal \\[ULN\\]). (Note: the criteria for adequate hematological function must be met without erythropoietin dependency, use of growth factors, or the requirement for transfusions of blood, coagulation factors, platelets, or albumin within 14 d of Treatment Day 1.)\n6. Patients with adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransaminase (ALT) levels of ≤ 5 × the ULN, and a total bilirubin level ≤ 1.5 × the ULN (patients with documented Gilbert disease are allowed to participate in the study if their total bilirubin level is ≤ 3 × the ULN).\n7. Patients with adequate renal function, defined as an estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin or an estimated creatinine clearance ≥ 40 mL\u002Fmin (measured or calculated using the Cockcroft-Gault formula).\n8. Women with childbearing potential (WOCBP)\n\n   1. Must have a negative serum human chorionic gonadotropin pregnancy test in the Screening Period.\n   2. Are using highly effective contraception, are not lactating, and agree not to become pregnant during the trial treatment period and for 187 days after treatment with the investigational drug.\n9. Men agree not to donate sperm or to father a child during the trial treatment period and for 97 days after treatment with the investigational drug.\n\nExclusion Criteria:\n\n1. Patients from vulnerable populations (incapacitated or unconscious individuals, persons deprived of liberty).\n2. Patients with a known allergic reaction or hypersensitivity to shellfish, crabs, crustaceans, or any components used in trial treatment.\n3. Patients with any prior treatment with IP-001 for Injection in a different clinical trial.\n4. Patients who underwent any surgical liver resection, hepatic ablation or other hepatic locoregional therapy for CRLM within 3 months before Treatment Day 1; patients who received any other medical procedure, SACT, or treatment with any other investigational anticancer agents within 14 days before Treatment Day 1, or patients who at study enrollment have plans to receive SACT or locoregional therapies\u002Fprocedures prior to intrahepatic or extrahepatic progression.\n5. Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 d of randomization. Inhaled or topical steroids and adrenal replacement steroid doses (\\> 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.\n6. Patients who at screening have not recovered back to baseline or ≤ Grade 1 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) guidelines v6.0 from ongoing conditions related to any prior medicinal or procedural treatments (including major surgery) except for residual toxicities, unless conditions are deemed clinically non-significant by the Investigator and\u002For stable on supportive therapy (in consultation with Sponsor Medical Monitor), such as alopecia or Grade 2 neuropathy.\n7. Patients with any extrahepatic nodal or non-nodal CRC metastases, except:\n\n   1. History of infiltrated regional lymph nodes associated with the primary tumor if these lymph nodes were removed together with the primary tumor.\n   2. Pulmonary nodules unless they are considered suspect for metastases because they show at least one of the following characteristics:\n\n   i. new or increasing in size (at least 20% increase in longest diameter) in the last 12 mo; ii. unequivocal 18F-FDG tracer-uptake on PET; iii. solitary nodule \\>1 cm; iv. 2 - 5 nodules with at least 1 ≥ 0.8 cm; v. more than 5 nodules (excluding nodules that are stable in size over at least 1 y).\n8. Patients with a history of another active malignancy within 2 years prior to Treatment Day 1, except for superficial skin cancers or localized, low-grade tumors deemed cured and not treated with systemic therapy. Patients with incidental prostate cancer may enroll if Stage ≤ T2N0M0 and Gleason score ≤ 6.\n9. Patients with bleeding diathesis or anti-coagulation treatment that cannot be stopped 24 hours prior to Treatment Day 1 (low-dose aspirin will be allowed).\n10. Patients who have one of the following cardiovascular disorders:\n\n    1. Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association classification III or IV), or\n    2. Unstable angina pectoris or a history of myocardial infarction within the last 6 mo, or\n    3. Serious arrhythmias requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia), or\n    4. Significant QT-prolongation (QTcF ≥ 480 msec on screening electrocardiogram \\[ECG\\] \\[QTcF interval is not relevant in patients with pacemaker-controlled arrythmia\\]), or\n    5. Uncontrolled hypertension, defined as a resting systolic blood pressure \\> 150 mmHg and\u002For resting diastolic blood pressure \\> 90 mmHg, which cannot be controlled by anti-hypertensive therapy.\n11. Patients with any of the following infections\u002Fdiseases:\n\n    1. Known history of human immunodeficiency virus infection,\n    2. Known active Hepatitis B or C viral infection,\n    3. Any uncontrolled active systemic infection requiring intravenous antimicrobial treatment during screening,\n    4. Any active, known, or suspected autoimmune disease.\n12. Patients with a requirement for hemodialysis or peritoneal dialysis.\n13. Patients with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan or cavitating pulmonary lesion(s) or a known endobronchial disease manifestation.\n14. Patients who received a live, attenuated vaccine within 28 days of Treatment Day 1.\n15. Patients with any other serious underlying medical, psychological, familial, or geographical condition that, in the judgment of the Investigator, may limit compliance with the study or place the patient at high risk for treatment-related complications.",{"count":54,"type":21},717,"INTERVENTIONAL",[57,58],"PHASE2","PHASE3","The goal of this clinical trial is to learn if a new injectable drug (IP-001), administered after standard liver tumor ablation, can help prevent cancer from returning in people (males\u002Ffemales, ≥18 years old) with colorectal cancer that has spread only to the liver. The study will determine if injecting IP-001 into a liver tumor(s) after ablation will reduce the risk of cancer coming back in the liver and from spreading elsewhere in the body, will stimulate the immune system, will have any side effects, and will help improve a patient's response to other cancer therapies.\n\nResearchers will compare a standard of care liver ablation alone (microwave ablation \\[MWA\\], a technique that destroys tumors using heat), with MWA plus a high-dose IP-001 or MWA with a low-dose IP-001. During the treatment procedures, the doctor first performs the standard microwave ablation to destroy the tumor. Then, in the experimental-drug arms, IP-001 is injected in and around the treated tumor area to activate the immune system locally so that the body is more likely to find and eliminate any remaining cancer cells.",[61,28,62,63,64],"Colorectal Cancer (CRC)","Rectal Cancer","Rectal Cancer With Liver Metastases","Colorectal Liver Metastasis (CRLM)",[66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83],"Colorectal liver metastases","Colorectal cancer","Microwave ablation","Thermal ablation","Intratumoral immunotherapy","Intratumoral injection","Immune activation","Ablation-induced immunity","Liver tumor ablation","Metastatic cancer","Cancer","IP-001","Tumor ablation","Systemic immune response","Interventional immuno-oncology","Interventional oncology","Abscopal effect","T-cell stimulation","NOT_YET_RECRUITING","2026-01-05",{"date":87,"type":36},"2026-01-07",{"date":89,"type":21},"2026-05",{"date":91,"type":21},"2033-12",{"name":93,"class":94},"Immunophotonics, Inc.","INDUSTRY",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":55,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":44},"100577697","phase-2-fmt-ql1706bevacizumab-xelox-as-first-line-treatment-for-advanced-mss-type-colon-cancer-with-liver-metastasis-100577697","NCT06801665","FMT+ QL1706+Bevacizumab+ XELOX as First-line Treatment for Advanced MSS-type Colon Cancer With Liver Metastasis","Fecal Microbiota Transplantation Combined With QL1706, Bevacizumab, and XELOX as First-line Treatment for Advanced MSS-type Colon Cancer With Liver Metastasis: A Prospective, Multi-center, Single-arm Phase II Study","Inclusion Criteria:\n\n1. Histological or cytological confirmed advanced colon cancer with liver metastasis.\n2. Signed written informed consent.\n3. Have not received anti-tumor treatment.\n4. According to the investigators assessment, at least one measurable target lesion defined by RECIST v1.1.\n5. Patients of both sexes, aged ≥18 years and ≤75 years.\n6. ECOG PS 0-1;\n7. Expected survival time ≥ 3 months;\n8. Have adequate organ and bone marrow function, laboratory examination within 7 days prior to enrollment meets the following requirements, as follows:\n\n1\\) Blood routine: ANC ≥ 1.5 × 10\\^9\u002FL, Platelet count ≥ 100 × 10\\^9\u002FL, HGB ≥100 g\u002FL (no blood transfusion or erythropoietin dependence within 14 days); 2) Liver function: TBIL ≤1.5 x ULN; ALT\u002FAST ≤ 5 x ULN; ALP ≤5×ULN; 3) Renal function: Cr ≤1.5×ULN, or creatinine clearance ≥50 mL\u002Fmin: Urine routine results showed urinary protein \\\u003C 2+; 4) Coagulation function: INR or PT ≤1.5 x ULN. 9.For female subjects of reproductive age, a urine or serum pregnancy test should be performed and the result is negative 3 days prior to receiving the initial study drug administration.\n\n10\\. For women of childbearing potential (WOCBP): agreement to refrain from heterosexual intercourse or use contraception.\n\n11\\. For men: agreement to refrain from heterosexual intercourse or use a condom, and agreement to refrain from donating sperm.\n\nExclusion Criteria:\n\n1. Suffered from other malignancies in the past 5 years, excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ and papillary thyroid carcinoma.\n2. Patients requiring elective surgery during the trial.\n3. Patients who cannot take oral drugs, or have conditions that the investigator determines to significantly affect gastrointestinal absorption, such as chronic diarrhea, intestinal obstruction, etc., and are not suitable for treatment.\n4. Patients during pregnancy (positive pregnancy test) or lactation.\n5. Central nervous system metastasis or meningeal metastasis.\n6. Uncontrollable bone metastasis, or patients at risk of fracture, requiring surgery, local radiation therapy.\n7. Patients with active infection requiring systemic anti-infection treatment.\n8. Patients with a history of immunodeficiency, including those who are positive for HIV antibody tests.\n9. Patients with known, active autoimmune diseases.\n10. Patients with uncontrolled active hepatitis B, patients with hepatitis C virus infection (HCV antibody positive).\n11. A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe arrhythmia, acute coronary syndrome within 6 months, congestive heart failure, aortic dissection, stroke, and T IA history.\n12. Severe bleeding events occur within half a year, or high bleeding risk factors such as active digestive tract ulcers and esophageal and gastric varices due to liver cirrhosis.\n13. Patients with diabetes who cannot be stably controlled by drugs (including insulin).\n14. Mental or language disorders that prevent communication with the patient;\n15. Patients participating in another clinical trial.\n16. MSI-H\u002F d MMR without immunotherapy; left colorectum of Ras, Raf wild-type.\n17. The investigator believes that the subject has other serious systemic diseases or other conditions that make him unsuitable for participation in this trial.","75 Years",{"count":104,"type":21},30,[57],"The investigators plan to initiate a prospective, multicenter, phase II study, recruiting 30 patients with advanced colon cancer patients with liver metastasis who have not received prior treatment. This study plans to reconstruct intestinal microecology through fecal microbiota transplantation (FMT), and combine with QL1706+Bevacizumab+XELOX to enhance the anti-tumor immune effect at the same time, thereby improving the prognosis of colon cancer patients with liver metastasis.",[28],"2025-12-28",{"date":110,"type":36},"2026-01-02",{"date":112,"type":36},"2025-04-17",{"date":114,"type":21},"2027-02-01",{"name":116,"class":43},"Hua Jiang",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":102,"enrollmentInfo":124,"targetDuration":4,"studyType":55,"phases":126,"briefSummary":128,"conditions":129,"keywords":130,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":4},"100521466","salt-for-unresectable-colorectal-liver-metastases-100521466","NCT06069960","SALT for Unresectable Colorectal Liver Metastases","Sequential Adult Left Lateral Lobe Liver Transplantation (SALT) in Patients With Unresectable Colorectal Liver Metastases: a Single-center, Prospective, Single-arm Study","Inclusion Criteria:\n\n1. Age 18-75;\n2. Physical fitness status (ECOG) 0\\~1;\n3. Histologically confirmed primary colorectal neoplasm. The time from primary colorectal tumor resection to transplantation is ≥3 months and the stage of primary colorectal tumor is ≤T3N1. Accept T4N0 or T4N2 if primary tumor resection interval is ≥ 2 years\n4. Liver metastases (CRLM) located in bilateral livers, or limited to liver and unresectable CRLM after discussion by MDT;\n5. According to PET\u002FCT, CT and MRI, there are no other abdominal metastases except the liver or 1-3 resectable lung metastases;\n6. Patients have received at least 6-8 weeks of first-line chemotherapy at the time of screening. According to RECIST criteria, CRLM was stable or partially regressed during and after treatment (still not completely resectable);\n7. The CEA (carcinoembryonic antigen) value before screening is ≤80 µg\u002FL or the highest level after treatment is reduced by ≥ 50%;\n8. Sign the informed consent form.\n\nExclusion Criteria:\n\n1. Extrahepatic tumor burden (except for resectable lung metastases) and\u002For large vessel tumor infiltration;\n2. The largest liver tumor lesion \\>5.5cm at the time of screening;\n3. Tumor progression during chemotherapy or severe comorbidities that make transplantation impossible;\n4. BRAF mutation and\u002For microsatellite instability primary tumor (MSI);\n5. Suffering from other primary malignant tumors in the past 5 years;\n6. Cardiopulmonary disease that cannot be corrected, with high surgical risk, or anatomical abnormality that makes liver transplantation impossible;\n7. Substance abuse, medical, psychological or social conditions may interfere with the patient's participation in the study or evaluation of the study results;\n8. Combined with AIDS and other diseases that affect surgery or tumor progression;\n9. Pregnant or lactating patients;\n10. Other reasons that the researchers think are not suitable for participation.",{"count":125,"type":21},40,[127],"NA","Colon cancer is a common malignancy with a low survival rate worldwide, and unresectable colon cancer liver metastases (ICRLM) have a worse prognosis. The liver is the most common metastatic organ of colorectal cancer, and palliative chemotherapy is the only option for most ICRLM patients. Regrettably, the median survival time of all patients receiving chemotherapy is only 2 years, and the 5-year survival rate is only 10%. Liver transplantation is an ideal choice for patients with ICRLM, which can significantly improve the postoperative survival rate. But the most serious problem facing such patients is the shortage of donor livers. In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment (2-3 segment) transplantation combined with delayed total hepatectomy can greatly alleviate the shortage of liver donors in the above-mentioned patients. Based on the experience of clinical operation, our center proposes and designs a clinical study of sequential adult left lateral lobe liver transplantation (SALT) for the treatment of iCRLM. On the basis of RAPID, the safety and efficacy of sequential adult left lateral lobe liver transplantation were evaluated for the above patients.",[28],[131,132,133],"liver transplantation","two-stage liver resection","colorectal liver metastases","2023-10-03",{"date":136,"type":36},"2023-10-06",{"date":138,"type":21},"2023-10-20",{"date":140,"type":21},"2027-06-30",{"name":142,"class":43},"RenJi Hospital"]