[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-metastases-of-colorectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-metastases-of-colorectal-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100651776","phase-2-hepatic-arterial-infusion-chemotherapy-in-patients-with-inoperable-colorectal-cancer-liver-metastasis-100651776",false,"NCT07764497","Hepatic Arterial Infusion Chemotherapy in Patients With Inoperable Colorectal Cancer Liver Metastasis","A Phase II Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Best Systemic Chemotherapy in Patients With Inoperable Hepatic Metastasis From Colorectal Cancer","HAIP-6192","Inclusion Criteria:\n\n1. History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. Patients with resectable or ablatable lung metastasis are eligible.\n2. Physically able to tolerate major partial hepatectomy.\n3. The primary tumor may be in place at the time of registration if not obstructing the intestinal lumen or significantly bleeding. If present, the primary tumor will be resected at the time of pump placement.\n4. Chest, Abdominal and Pelvic CT scan with CT angiogram within 6 weeks prior to registration. (MRI angiogram with contrast of the abdomen may be substituted for CT of the abdomen).\n5. The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist. In the event that two hepatobiliary surgeons cannot agree, a third surgeon will be consulted. Continued discrepancy will result in the patient's case being presented at weekly hepatobiliary conference for consensus opinion. Inoperable metastases are defined as: requiring a resection that leaves less than 2 hepatic segments (not including the caudate lobe) behind with adequate arterial\u002Fportal inflow, venous outflow and biliary drainage. \\* A patient is considered resectable if the procedure includes a minor wedge or thermo-ablation encompassing 10% or less of the volume of the remaining 2 segments.\n6. Patient's liver metastases must comprise \\\u003C70% of the liver parenchyma.\n7. Female patients of child-bearing age must undergo a pregnancy test and have a negative result.\n8. A patient must have had prior chemotherapy.\n9. ECOG PS \\\u003C 2.\n10. Within 14 days of registration: o WBC \\>3X10E9\u002FL; ANC ≥ 1.5X10E9\u002FL; Platelet count \\>100X10E9\u002FL; INR \\\u003C 1.5; HGB ≥ 90 g\u002FL; Estimated creatinine clearance ≥30 ml\u002Fmin (using Cockcroft and Gault formula); Total serum bilirubin \\\u003C25.6 umol\u002FL.\n11. Age ≥ 18 years.\n12. Signed informed consent.\n13. Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n14. Patients with limited\u002Fresponding lung metastases on Physician's discretion.\n\nExclusion Criteria:\n\n1. Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration).\n2. Patient may not have received prior treatment with FUDR.\n3. Active infection, ascites, hepatic encephalopathy.\n4. Active concurrent malignancies, except a patient's potentially resectable colorectal primary.\n5. Extrahepatic metastases except for resectable or ablatable lung metastasis.\n6. Patient must not have obstruction of GI or GU tract.\n7. Female patients who are pregnant or lactating.\n8. Patients may not be receiving any other investigational agents.\n9. Patients with history of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke will also be excluded (history of stroke or transient ischemic attack within 6 months prior to Day 1).\n10. Serious or non-healing active wound, ulcer, or bone fracture.\n11. Chronic daily treatment with aspirin (\\> 325 mg\u002Fd) or nonsteroidal anti- inflammatory medications known to inhibit the platelet function.\n12. Presence of bleeding diathesis or coagulopathy.\n13. History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure of \\> 150\u002F100 mmHg on medication), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e. atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or peripheral vascular disease (Grade II or greater).","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to assess how many patients with initially inoperable colorectal liver metastasis are able to have a liver surgery after treatment with hepatic artery infusion chemotherapy and standard of care systemic chemotherapy.",[27,28,29,30],"Colorectal Adenocarcinoma Metastatic in the Liver","Liver Metastasis Colon Cancer","Liver Metastases From Colorectal Cancer","Liver Metastases of Colorectal Cancer","RECRUITING","2026-08-11",{"date":34,"type":35},"2026-08-14","ACTUAL",{"date":37,"type":35},"2014-07",{"date":39,"type":21},"2036-12",{"name":41,"class":42},"Sunnybrook Health Sciences Centre","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100553809","phase-2-chemotherapy-plus-egfr-monoclonal-antibody-in-patients-with-liver-metastases-from-colorectal-cancer-with-ctdna-superselective-negative-genes-100553809","NCT06490913","Chemotherapy Plus EGFR Monoclonal Antibody in Patients With Liver Metastases From Colorectal Cancer With ctDNA Superselective Negative Genes","Chemotherapy Plus EGFR Monoclonal Antibody in Patients With Liver Metastases From Colorectal Cancer With ctDNA Superselective Negative Genes：a Phase II Single-arm Study","Inclusion Criteria:\n\n* 18-75 years (including 18 and 75 years);\n* ECOG PS 0 or 1;\n* Colorectal cancer diagnosed histologically and\u002For cytologically with metastatic or recurrent lesions that are not curable with surgery;\n* Patients with liver metastases of RAS wild-type colorectal cancer who have not received prior treatment;\n* At least one measurable lesion as defined in RECIST version 1.1;\n* Fertile patients must be willing to take highly effective pregnancy avoidance measures during the study period and ≥120 days after the last dosing; Female patients with negative urine or serum pregnancy test results within ≤7 days before the first administration of the study drug;\n* Have fully understood the study and voluntarily signed the informed consent.\n* Adequate organ and bone marrow function, meeting the following definitions:\n\n  1. Blood routine (no transfusion, no use of granulocyte colony stimulating factor \\[G-CSF\\], no use of other drugs for correction within 14 days before treatment); Absolute neutrophil count (ANC) ≥1.5×109\u002FL; Hemoglobin (HB) ≥9.0 g\u002FdL; Platelet count (PLT) ≥80×109\u002FL;\n  2. Blood biochemistry, serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL\u002Fmin; Serum albumin ≥2.8g\u002FdL. Patients with poor nutritional status before neoadjuvant therapy could also be enrolled if they met the criteria through parenteral nutrition. Total bilirubin (TBIL) ≤ 1.5×ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;\n\nExclusion Criteria:\n\n* Pregnant or lactating women;\n* Patients with a known history of allergy to any investigative drug, similar drug, or excipient;\n* Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;\n* Patients with a history of thromboembolism, except thrombosis caused by PICC;\n* There are patients with active infection;\n* Patients with difficult to control hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90mmHg);\n* Patients with brain metastases with clinical symptoms or imaging evidence;\n* Treatment contraindications exist in combination with other chronic diseases;\n* Patients with previous immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, nephritis and other conditions, and the current AE is still ≥ grade 2;\n* According to NCI CTCAE version 5.0 evaluation criteria, existing patients with various toxic and side effects caused by previous treatment ≥ grade 2;\n* Other conditions that the investigator determined were not suitable for inclusion in the study.\n* Received any anti-tumor therapy and participated in other clinical studies within 4 weeks before enrollment.","75 Years",{"count":53,"type":21},33,[24],"The purpose of this Phase II single-arm study is to prospectively explore the efficacy of chemotherapy plus EGFR inhibitors in patients with liver metastases from total wild-type colorectal cancer with ctDNA superselective negative genes.",[30],"NOT_YET_RECRUITING","2024-07-01",{"date":60,"type":35},"2024-07-08",{"date":62,"type":21},"2024-11-01",{"date":64,"type":21},"2025-12-31",{"name":66,"class":67},"Fujian Cancer Hospital","OTHER_GOV"]