[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-colorectal-carcinoma-mcrc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-colorectal-carcinoma-mcrc":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,69,96,123,158,181],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100636531","phase-1-a-phase-i-study-to-evaluate-the-safety-and-efficacy-of-l19il2-in-combination-with-ruxolitinib-in-patients-with-advanced-solid-tumors-100636531",false,"NCT07566897","A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of one of the following tumor types for which no further approved systemic treatment options are available:\n\n   1. Unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, that has progressed following:\n\n      * at least one prior line containing FOLFIRINOX and\u002For gemcitabine plus nab-paclitaxel, and\n      * at least one approved second-line regimen (e.g., 5-FU\u002Fleucovorin plus liposomal irinotecan), or where these regimens are not suitable due to contraindication or prior intolerance\n   2. Metastatic proficient mismatch repair \u002F microsatellite stable (pMMR\u002FMSS), BRAF V600E-negative colorectal adenocarcinoma, that has progressed following:\n\n      * at least one prior line of systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan, with or without anti-VEGF and, if RAS wild-type, with or without anti-EGFR, and\n      * at least one approved subsequent line of therapy with trifluridine-tipiracil, regorafenib or fruquintinib, or where these agents are not suitable due to contraindication or prior intolerance;\n   3. Metastatic clear cell renal cell carcinoma, that has progressed following:\n\n      * at least one prior PD-(L)1-based systemic regimen, and\n      * at least one VEGF-targeted tyrosine kinase inhibitor (TKI), or where these treatments are not suitable due to contraindication or prior intolerance\n2. Patients must have no further approved and available therapy options or be documented as ineligible or intolerant.\n3. Patients must have radiographic disease progression on\u002Fafter the last line of prior treatment.\n4. At least one unidimensionally measurable lesion as defined by RECIST v.1.1.\n5. Eastern cooperative oncology group (ECOG) performance status ≤ 2.\n6. Patient has an estimated life expectancy of at least 12 weeks.\n7. Hemoglobin \\> 10.0 g\u002FdL.\n8. Platelets ≥ 100 x 109\u002FL.\n9. Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL.\n10. Negative TB test (e.g., Mantoux or Quantiferon assay).\n11. Documented negative test for HIV, HBV, HCV excluding active infection is needed. For HBV serology: the determination of HBsAg and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and\u002For anti-HBc Ab), negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n12. Serum creatinine \\\u003C 1.5 x ULN and estimated Glomerular Filtration Rate (eGFR) value above 75 mL\u002Fmin\u002F1.73m2. An age-calibrated definition of Chronic Kidney Disease (CKD) has been proposed to distinguish age-related from disease-related changes in eGFR. For patients younger than 40 years, CKD is defined by estimated Glomerular Filtration Rate (eGFR) below 75 mL\u002Fmin\u002F1.73m2.\n13. All acute toxic effects (excluding alopecia) of any prior therapy must have been resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.5.0) Grade ≤ 1.\n14. Women Of Childbearing Potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to six months following the last study treatment administration, highly effective contraception methods, as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner. Double-barrier contraception is required.\n15. Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to six months following the last study treatment administration. Double-barrier contraception is required.\n16. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. Patients with primary brain tumors, brain metastases or CNS disease will be excluded.\n2. Chemotherapy, immunotherapy, or radiation therapy at the tumor sites within 4 weeks prior to study treatment start.\n3. Active or history of autoimmune disease that might deteriorate when receiving an immunostimulatory agent.\n4. Previous or concurrent cancer type that is distinct from the cancer being evaluated in this study. Exception made for any other cancer curatively treated ≥ 2 years prior to study treatment start.\n5. Presence of active severe bacterial or viral infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.\n6. Impaired cardiocirculatory functions due to any of the following conditions:\n\n   a History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.\n\n   b Inadequately controlled cardiac arrhythmias including atrial fibrillation. c Heart insufficiency (\\> Grade II, New York Heart Association (NYHA) criteria). d Any abnormalities observed during baseline ECG and Echocardiogram investigations are considered clinically significant by the investigator.\n\n   e Uncontrolled hypertension defined by systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg.\n\n   f Ischemic peripheral vascular disease (Grade IIb-IV).\n7. Known arterial aneurysms.\n8. INR \\> 3.\n9. Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 x ULN). At the discretion of the investigator, an increased exclusion threshold for patients with liver metastasis can be accepted as follows: ALT, AST and ALP ≥ 5 x ULN.\n10. Known uncontrolled coagulopathy or bleeding disorder, if the subject is being treated for coagulopathy or bleeding disorder and has tests within screening limits, he\u002Fshe may be included.\n11. Known hepatic cirrhosis or severe pre-existing hepatic impairment (Child-Pugh class B or C).\n12. Moderate to severe respiratory failure.\n13. Patient requires or is taking systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma\u002FCOPD is not considered an exclusion criterion.\n14. Known history of allergy to an excipient in study medication (e.g. IL2, ruxolitinib) or other human proteins\u002Fpeptides\u002Fantibodies.\n15. Pregnancy or breast-feeding.\n16. Severe diabetic retinopathy.\n17. Recovery from major trauma including surgery within 4 weeks prior to enrollment.\n18. Patient with iatrogenic or pathologic severe immune suppression.\n19. Requirement of concurrent use of other anti-cancer treatments or agents other than study medication.\n20. Patient taking herbal medications within 7 days prior to study treatment start.\n21. Anticoagulation therapy with P2Y12 antagonists (e.g., clopidogrel, ticagrelor) and vitamin K antagonists (e.g., phenprocoumon, warfarin).","ALL","18 Years","75 Years",{"count":19,"type":20},96,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This trial aims to address unmet medical needs in advanced solid tumors, specifically metastatic clear cell renal carcinoma, locally advanced or metastatic pancreatic adenocarcinoma, and metastatic colorectal adenocarcinoma.",[26,27,28,29],"Renal Carcinoma Metastatic","Pancreatic Adenocarcinoma Metastatic","Pancreatic Adenocarcinoma","Metastatic Colorectal Carcinoma (mCRC)",[31,32],"Ruxolitinib","Advanced solid tumors","NOT_YET_RECRUITING","2026-04-28",{"date":36,"type":37},"2026-05-05","ACTUAL",{"date":39,"type":20},"2026-05-01",{"date":41,"type":20},"2030-05",{"name":43,"class":44},"Philogen S.p.A.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100566435","oscar-ii-study---the-oncobind-ctc-removal-study-100566435","NCT06655142","OSCAR II STUDY - The ONCObind CTC Removal Study","Prospective Matched Control Feasibility Study to Determine the Capacity of the Onco-Seraph 100 Microbind® Affinity Blood Filter ( ONCObind Procedure) to Remove Circulating Tumor Cells From the Blood in Patients With Either Metastatic Pancreatic Adenocarcinoma or Metastatic Colorectal Carcinoma","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a patient must meet all of the following criteria:\n\n1. Patients ≥ 18 years of age with\n\n   1. mPDAC cohort: Metastatic pancreatic ductal cancer who experienced disease progression or not tolerating fluoropyrimidine-, oxaliplatin- and irinotecan- based regimens or prior treatment with gemcitabine and nab-paclitaxel or are not a candidate for chemotherapy\n   2. mCRC Cohort : Metastatic CRC who experienced disease progression on 5-fluorouracil (5-FU), capecitabine, oxaliplatin and irinotecan as FOLFIRI and\u002For FOLFOX and\u002For XELOX and\u002For XELIRI and\u002For FOLFOXIRI\u002FFOLFIRINOX or who are not candidates for chemotherapy.\n2. Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) scores of 2 or less.\n3. Patient or legally authorized representative is willing and able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.\n4. Patients with a CTC concentration of at least 5 cells\u002FmL\n5. Must be willing to provide blood samples for prospective tumor molecular profiling and exploratory analyses.\n6. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.\n7. Patients must be of non-childbearing potential or using a medically acceptable contraceptive regimen. Effective contraception includes surgical sterilization (e.g., vasectomy, tubal ligation), two forms of barrier methods (e.g., condom, diaphragm) used with spermicide, IUDs.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnant or breast feeding\n2. Patients who cannot tolerate the placement of a tunneled catheter for vascular access to enable extracorporeal treatment.\n3. Patients with a history of heparin induced thrombocytopenia (HIT).\n4. Patients with known allergy to heparin sodium.\n5. High risk of bleeding (platelet count \\\u003C50mm3 or International Normalized Ratio (INR) \\>1.5)\n6. Hemodynamic instability and inability to tolerate extracorporeal therapy (defined as MAP\\\u003C65 despite fluids and vasopressors and or sustained hypotension at enrollment as defined by two readings with systolic blood pressure (SBP) measurements below 100 mmHg or diastolic blood pressure (DBP) measurements below 50 mmHg. The measurements must be performed thirty minutes from one another, and the Subject must be resting for at least 5 minutes prior to obtaining each measurement. (If the first reading includes a SBP greater than 100 mmHg and a DBP greater than 50 mmHg, the second reading does not need to be taken).\n7. Uncontrolled hypertension despite optimal management (systolic blood pressure \\>180mmHg\n8. Ongoing uncontrolled, serious infection.\n9. Renal failure requiring dialysis.\n10. Patients with a life expectancy of less than 30 days.\n11. Participation in an investigational drug study or history of receiving any investigational treatment within 14 days prior to initiation of treatment on this study.\n12. Concurrent participation in any interventional clinical trial or has been previously entered in this trial.\n13. The Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.\n14. Unable to obtain informed consent from either patient or legally authorized representative (LAR)\n15. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.",{"count":54,"type":20},120,[56],"NA","This study is a Prospective Single Arm, dual cohort Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel extracorporeal blood purification (EBP) procedure in either mPDAC or mCRC refractory to systemic therapy. Site selection will be dependent upon the site's familiarity with extracorporeal blood purification platforms as well as the diagnosis and management of mPDAC and mCRC. Adults (18 years old and older, ECOG PS of equal or less than 2) with a diagnosis of either mPDAC as defined histologically (microscopically) as a \"pancreatobiliary type\" adenocarcinoma who experienced disease progression or not tolerating fluoropyrimidine-, oxaliplatin- and irinotecan- based regimens or prior treatment with gemcitabine and nab-paclitaxel or are not candidates for chemotherapy or mCRC patients who experienced disease progression on 5-fluorouracil (5-FU), capecitabine, oxaliplatin and irinotecan as FOLFIRI and\u002For FOLFOX and\u002For XELOX and\u002For XELIR and\u002For FOLFOXIRI\u002FFOLFIRINOX or who are not candidates for chemotherapy with at least 5 cells\u002FmL CTCs in peripheral blood and\u002For portal vein.",[59,29],"Pancreatic Ductal Adenocarcinoma (mPDAC)","2026-04-15",{"date":62,"type":37},"2026-04-17",{"date":64,"type":20},"2027-01-15",{"date":66,"type":20},"2028-07",{"name":68,"class":44},"ExThera Medical Corporation",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":45},"100628589","phase-1-safety-and-efficacy-of-tegavivint-in-patients-with-metastatic-colorectal-carcinoma-100628589","NCT07463599","Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma","A Phase 1\u002F2, Dose Escalation and Expansion Trial to Evaluate the Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma","Inclusion Criteria:\n\n1. Signed informed consent form (ICF)\n2. Male or female, 18 years of age or older\n3. Histologically and\u002For cytologically documented metastatic colorectal adenocarcinoma (all other histological types are excluded)\n\n   a. RAS, BRAF, and MSI\u002F dMMR (Mismatch repair deficiency) status for each patient must be documented.\n4. Disease progression or intolerance to ≥ 2 lines of systemic therapy for advanced\u002Fmetastatic disease, including the following prior therapies unless contraindicated: fluoropyrimidine-, oxaliplatin- and irinotecan-based regimens, an anti-vascular endothelial growth factor (VEGF) therapy, and if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy.\n\n   1. Prior treatment with trifluridine-tipiracil or fruquintinib is allowed\n   2. Patients with BRAF-mutant tumors must have been treated with a BRAF inhibitor\n   3. Patients with microsatellite-high or mismatch repair deficient tumors must have been treated with immune checkpoint inhibitors\n5. Measurable disease as defined by RECIST 1.1. Lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if progression has been demonstrated in such lesions.\n6. Willingness and ability to provide tumor biopsies during screening and while on treatment. On trial, biopsies considered low risk are required, moderate risk procedures are optional, and no high-risk procedures are allowed.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to the first dose of the investigational product(s)\n8. Patients must have organ and marrow function as defined below during screening and performed by local laboratories within 7 days of the first dose of the investigational product(s):\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL\n   2. Platelets ≥ 100 × 109\u002FL; no transfusion within 7 days prior to the screening laboratory assessment\n   3. Hemoglobin ≥ 9 g\u002FdL\n   4. Total bilirubin ≤ upper limit of normal (ULN)\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN if liver function abnormalities are due to underlying liver metastasis\n   6. Renal function\n\n   \u003C!-- -->\n\n   1. Estimated creatinine clearance (CrCl) ≥ 50 mL\u002Fmin by the Cockcroft-Gault equation using actual body weight, or\n   2. Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL\u002Fmin\u002F1.73m2 by Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) Creatinine Equation, or\n   3. Measured creatinine clearance ≥ 50 mL\u002Fmin\n   4. Note: If estimated CrCl or eGFR is abnormal, accurate measurement may be obtained by 24-hour urine collection to measure creatinine clearance.\n\n   g. International normalized ratio (INR) ≤ 1.5 × ULN, unless the patient is receiving anticoagulant therapy as long as the patient is within therapeutic range of intended use of anticoagulants h. Urine protein \\\u003C100mcg on urinalysis or 24-hour urine protein \\\u003C 2 grams\n9. Washout or recovery period prior to Day 1 of Cycle 1:\n\n   1. At least 21 days from the last dose of prior systemic anticancer treatment\n   2. At least 14 days from palliative radiotherapy (≤ 10 fractions or ≤30 gray \\[Gy\\] total dose or at least 28 days from radiotherapy \\> 30 Gy) to extrahepatic tumor lesions\n   3. At least 28 days from local or loco-regional therapy of intrahepatic tumor lesions (e.g., surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation)\n   4. At least 28 days from any major surgery and adequate wound healing has occurred. Major surgery is defined as any significantly invasive procedure into a major body cavity (abdomen, cranium etc.) and\u002For surgery requiring extensive recuperation (joint replacement). Please discuss with the medical monitor if there are any questions.\n10. Grade ≤ 1 toxicity due to any previous cancer therapy according to the NCI-CTCAE v.5. Grade 2 is allowed in case of alopecia and\u002For peripheral sensory neuropathy.\n11. Patients with past Hepatitis C virus (HCV) infection will be eligible for the trial. The treated patients must have completed their treatment at least 1 month prior to starting trial intervention and HCV viral load must be below the limit of quantification.\n12. Patients with controlled Hepatitis B virus (HBV) will be eligible if they meet the following criteria:\n\n    1. Antiviral therapy for HBV must be given for at least 4 weeks, and HBV viral load must be less than 500 IU\u002FmL prior to first dose of trial drug. Patients on active HBV therapy with viral loads under 100 IU\u002FmL should stay on the same therapy throughout trial intervention.\n    2. Patients who are positive for anti-hepatitis B core antibody (HBcAb), negative for hepatitis B surface antigen (HBsAg), and negative or positive for anti-hepatitis B surface antibody (HBs), and who have an HBV viral load under 100 IU\u002FmL, do not require HBV antiviral prophylaxis.\n    3. Patients must have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤ 150\u002F90 mm Hg at Screening and no change in antihypertensive medications within 1 week before Cycle 1 Day 1.\n\nExclusion Criteria:\n\n1. Patients receiving therapy with other anti-neoplastic or experimental agents.\n2. Patients receiving concomitant strong or moderate inhibitors of CYP3A4\u002F5 that cannot be discontinued 7 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.\n3. Patients receiving concomitant strong or moderate inducers of CYP3A4\u002F5 that cannot be discontinued at least 14 days prior to Cycle 1 Day 1.\n4. Patients with known history of Gilbert's syndrome or other genetic conditions affecting UGT1A1 function.\n5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to tegavivint, or other agents and excipients used in the trial including allergic reactions to Food, Drug, and Cosmetic (FD\\&C) Yellow No. 5 (Tartrazine) or No. 6 (Sunset Yellow FCF).\n6. Malignant disease, other than that being treated in this trial. Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) who have undergone potentially curative therapy are not excluded. Other exceptions include malignancies that were treated curatively and have not recurred within 3 years prior to Cycle 1 Day 1 and any malignancy considered indolent and that has never required therapy.\n7. Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of trial samples.\n8. Inability to swallow capsules or tablets.\n9. Known central nervous system (CNS) involvement including carcinomatous meningitis.\n10. Ongoing or active infection (exception: HBV infection - see inclusion criteria).\n11. Patients with large varices at risk of significant bleeding that are not being treated with conventional medical intervention: beta blockers or endoscopic treatment. Assessment of varices for patients in whom conventional medical intervention for known varices is already in place should be performed by endoscopy as per local standard of care.\n12. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months before the start of trial medication.\n13. Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality, or hypertension including any of the following:\n\n    * Congestive heart failure, New York Heart Association (NYHA) \\> Class II\n    * Uncontrolled hypertension (systolic blood pressure \\>150 mmHg or diastolic pressure \\> 90 mmHg despite optimal medical management)\n    * Unstable angina pectoris or cardiac arrhythmia\n    * Baseline QTc (Fridericia) ≥ 450 milliseconds. In the event a QTc (QT interval corrected Fridericia) measurement is not possible due to factors such as a pacemaker or bundle branch block, the patient may be evaluated by a cardiologist who must document no apparent increased risk for Torsades de Point or other morbidity associated with prolonged QTc. With such documentation, the patient may be eligible based with additional medical monitor review.\n    * Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome\n    * Myocardial infarct within 6 months before Cycle 1 Day 1\n    * Clinically significant pericardial disease\n14. Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for PK interactions.\n15. Pregnant and breastfeeding women are excluded from this trial. The effects of tegavivint on the developing human fetus have the potential for teratogenic or abortifacient effects. There is an unknown but potential risk for Adverse Effects in nursing infants secondary to treatment of the mother with tegavivint.\n16. Women of child-bearing potential (WOCBP) and men who are sexually active with WOCBP who do not agree to use one highly effective method of contraception, including hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device or intrauterine system; vasectomy or tubal ligation; and one effective method of contraception, including male condom, female condom, cervical cap, diaphragm or contraceptive sponge or abstaining from sex for the duration of trial participation and for at least 6 months following completion of dosing (if applicable). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, she should inform her treating physician immediately.\n17. Any other clinically significant disease or condition that, in the opinion of the investigator, may affect adherence to the protocol, or the signing of the ICF by the patient, or make participation in this clinical trial inappropriate.",{"count":77,"type":20},126,[23,79],"PHASE2","This trial will evaluate the safety, tolerability, and preliminary efficacy of tegavivint as monotherapy (single) and in combination with standard therapies in patients with metastatic colorectal carcinoma (mCRC).",[29,82,83,84],"Colorectal Cancer (CRC)","Adenomatous Polyposis Coli (APC) Gene Mutation","Catenin Beta-1 (CTNNB1) Gene Mutation","RECRUITING","2026-03-09",{"date":88,"type":37},"2026-03-11",{"date":90,"type":37},"2026-02-17",{"date":92,"type":20},"2029-07",{"name":94,"class":95},"HonorHealth Research Institute","OTHER",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":45},"100610218","exosome-derived-extrahepatic-metastasis-detection-by-liquid-biopsy-in-colorectal-cancer-liver-metastases-100610218","NCT07224724","Exosome-derived Extrahepatic Metastasis Detection By Liquid Biopsy In Colorectal Cancer Liver Metastases","EXELION","Inclusion Criteria:\n\n* Adults (≥18 years old)\n* Histologically- or cytologically-confirmed colorectal cancer that is metastatic\n* Availability of pre-treatment plasma samples\n* Written informed consent provided\n* Sufficient clinical and imaging data to determine presence\u002Fabsence of extrahepatic metastasis\n\nExclusion Criteria:\n\n* Prior malignancies within 5 years\n* Poor sample quality or hemolysis\n* Inability to provide informed consent",{"count":104,"type":20},500,"OBSERVATIONAL","Colorectal cancer is the third most common malignancy worldwide, and prognosis largely depends on how effectively metastatic disease is managed. The liver is the most frequent and prognostically important site of metastasis, and patients responding well to chemotherapy may become candidates for curative hepatic resection. However, the presence of extrahepatic metastasis (EHM) critically influences treatment eligibility and survival. Although clinical scores such as the Fong and Beppu systems include EHM as a determinant, its detection by imaging remains limited, especially for small or occult lesions. Accurate identification of EHM is also essential when considering liver transplantation for unresectable colorectal liver metastases (CRLM), where EHM remains an exclusion criterion.\n\nThe EXELION Study aims to develop a non-invasive diagnostic model using serum exosomal microRNAs (miRNAs) to detect both hepatic and extrahepatic metastases in patients with CRLM. By integrating circulating miRNA profiling with machine learning-based analysis, this study seeks to supplement imaging diagnostics, improve treatment stratification, and enhance clinical decision-making for metastatic colorectal cancer.",[108,29],"Colorectal Cancer Liver Metastases (CRLM)",[110,111,112,113],"CRC","Extrahepatic metastasis","liquid biopsy","Early detection","2026-01-27",{"date":116,"type":37},"2026-01-28",{"date":118,"type":37},"2024-06-01",{"date":120,"type":20},"2026-06-18",{"name":122,"class":95},"City of Hope Medical Center",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":144,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":45},"100493464","phase-2-olanzapine-for-the-management-of-cancer-associated-appetite-loss-in-patients-with-advanced-esophagogastric-hepatopancreaticobiliary-colorectal-or-lung-cancer-100493464","NCT05705492","Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer","ACTO: A Phase II, Randomized, Placebo-Controlled Study Evaluating Olanzapine in the Management of Cancer Cachexia","Inclusion Criteria:\n\n* Willingness to provide written informed consent\n* Individuals \\>= 18 years of age\n* Histologically confirmed advanced local or metastatic esophogastric, hepatopancreaticobiliary, colorectal, or lung cancer diagnosis within 12 weeks of screening\n* Patients with weight loss as defined by international consensus criteria (documented or patient-reported):\n\n  * ≥ 5% weight loss over the past 6 months\n  * ≥ 2% weight loss with body mass index (BMI) \\\u003C20 kg\u002Fm\\^2 or sarcopenia\n* Planned or ongoing first-line palliative antineoplastic therapy (cytotoxic chemotherapy, targeted therapy, immunotherapy, combinations) with or without radiation therapy and have not started the second cycle of first-line palliative antineoplastic therapy. Patients may have received adjuvant antineoplastic therapy at least 6 months prior to screening\n* Able to ambulate independently with or without assistive devices (e.g., cane, walker)\n* In the case of brain metastases, the individual must be asymptomatic or previously treated with a full cycle of therapy with recovery from any acute effects of radiation therapy or surgery before screening. Such individuals must have discontinued corticosteroid treatment and be neurologically stable for at least 4 weeks before screening\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Able and willing to discontinue the use of any drug or over-the-counter (OTC) product that may interact with the study drug (within a period sufficient for wash-out per the principal investigators \\[PI's\\] discretion) and thereafter while on the study\n* Willingness to comply with restrictions on chest\u002Fbreastfeeding\n* Individuals capable of childbearing and contributing viable sperm must be willing to comply with contraception requirements and not donate ova or sperm while on the study and for 1 month after that\n* A negative pregnancy test at baseline (BL) must be obtained for individuals capable of childbearing\n\nExclusion Criteria:\n\n* Plan for, or history of (within 30 days of enrollment), the use of an antipsychotic drug, including, but not limited to, risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone. This limitation does not include prochlorperazine and other phenothiazines as antiemetic therapy. The use of antipsychotics concurrent with protocol therapy will not be allowed\n* Current use of medications or supplements with the goal of enhancing appetite within ≥14 days, including:\n\n  * megestrol acetate\n  * cannabinoids (including, but not limited to dronabinol, medical cannabis, over the counter \\[OTC\\] cannabinoid products), and\u002For\n  * Corticosteroids (defined as ≥ 5mg of prednisone \\[or equivalent per day\\]), except for standard-of-care chemotherapy-induced nausea and vomiting prophylaxis\n* Known history of poorly controlled diabetes, defined as fasting morning blood sugars ≥300 mg\u002FdL or recent hemoglobin A1≥ 8. Individuals with diabetes will undergo hemoglobin A1c (HbA1c) blood testing if they do not have HbA1c results 12 weeks prior to enrollment\n* Inadequate organ function, which may include, but is not limited to, the following laboratory results within 28 days before signing consent:\n\n  * Total bilirubin ≥5x upper limit of normal (ULN), aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SPGT\\]) ≥5X ULN (unless the participant has documented Gilbert's syndrome, hepatocellular carcinoma, or hepatic metastases)\n  * Primary investigator (PI) discretion will determine continued eligibility after randomization occurs in the event the liver function test results are above the proposed ULN\n  * Renal disease requiring dialysis or calculated glomerular filtration rate (GFR) ≤ 30 mL\u002Fminute\u002F1.73 m\\^2 as calculated by the modification of diet in renal disease (MDRD) equation\n* Tube feeding or parenteral nutrition at the time of screening\n* Any condition that may negatively impact oral absorption of the study drug (including, but not limited to dysphagia, mucositis, gastrectomy, colitis, bowel obstruction, high output ileostomy) or any plan to undergo an intervention that will render such a condition\n* Recurrent ascites unresponsive to medical interventions and requires therapeutic paracentesis\n* Uncontrolled symptoms at randomization make the individual unsuitable for the study in the judgment of the PI. If uncontrolled symptoms can be effectively palliated for ≥1 week prior, enrollment may be considered at the discretion of the PI\n* Uncontrolled infection, including coronavirus disease 2019 (COVID-19), at time of randomization. Individuals with the uncontrolled infection will not be eligible as the symptomology of infection may obscure the outcomes of this study\n* Other medical or psychiatric condition, including recent (within 1 year) or active suicidal ideation\u002Fbehavior or laboratory abnormality, may increase the risk of study participation or, in the PI's judgment, makes the participant inappropriate for the study",{"count":131,"type":20},66,[79],"This phase II trial tests how well olanzapine works in managing cancer cachexia in patients experiencing esophagogastric, hepatopancreaticobiliary, colorectal, or lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) -associated appetite loss while receiving non-curative cancer therapy. Loss of appetite (\"anorexia\") in the setting of cancer is a key feature of \"cachexia,\" a syndrome associated with loss of weight and muscle as well as weakness and fatigue. Olanzapine is a drug that targets key neurotransmitters (a type of molecule in the central nervous system that transmits messages to the rest of the body) that may stimulate appetite, restore caloric intake, minimize weight loss, and improve quality of life (QOL).",[135,136,137,138,139,140,141,29,142,143],"Advanced Malignant Solid Neoplasm","Advanced Biliary Tract Carcinoma","Advanced Esophageal Carcinoma","Metastatic Esophageal Carcinoma","Locally Advanced Colorectal Carcinoma","Locally Advanced Esophageal Carcinoma","Locally Advanced Gastric Carcinoma","Advanced Lung Carcinoma","Locally Advanced Hepatocellular Carcinoma",[145,146,147,148],"cancer","cachexia","weight loss","loss of appetite","2026-01-19",{"date":151,"type":37},"2026-01-21",{"date":153,"type":37},"2024-07-17",{"date":155,"type":20},"2026-12-31",{"name":157,"class":95},"OHSU Knight Cancer Institute",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100604506","phase-2-second-line-doublet-chemotherapy-folfox-or-folfiri-plus-fruquintinib-versus-doublet-chemotherapy-folfox-or-folfiri-plus-bevacizumab-in-metastatic-colorectal-cancer-100604506","NCT07150403","Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer","A Phase II, Open-label, Non-comparative, Randomized Study of Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* \\- Age ≥ 18 years and ≤ 80 years; provided the score of the G8 geriatric questionnaire is \\>14 for patients 75 years or older\n* Patients with a histologically confirmed diagnosis of metastatic colorectal cancer (mCRC), with a documented disease progression (as per RECIST v1.1, assessed by the investigator and confirmed through CT or MRI).\n* Patients must have previously received first-line therapy with Bevacizumab or an EGFRi, in combination with either FOLFOX or FOLFIRI, for non-resectable mCRC. Patients who progressed during the adjuvant chemotherapy (FOLFOX) or within the 6 months following its completion are eligible for inclusion\n* Patients must have an unresectable tumor at the time of enrollment.\n* Patients must have at least one measurable\u002Fevaluable metastatic lesion according to RECIST v1.1 criteria; images have to be available for collection\n* Metastases not amenable to surgery and\u002For thermo-ablation and\u002For stereotaxic radiotherapy\n* WHO performance status 0 or 1\n* Available parameters to compute the SPOD score: WHO PS, hemoglobin, platelet count, WBC\u002Fabsolute neutrophil count ratio, lactate dehydrogenase (LDH), alkaline phosphatase, and the number of metastatic sites.\n* Adequate liver functions: Total Bilirubinemia \\\u003C 2,5 ULN, AST and ALT ≤ 5 ULN\n* Adequate hematological (Hemoglobin ≥10g\u002FdL, platelets ≥100G\u002FL, neutrophils ≥1.5G\u002FL) and renal (creatinine clearance ≥ 50 mL\u002Fmin according to CKD-EPI) functions\n* Proteinuria \\\u003C 2+ (dipstick urinalysis) (if 2+ or more, proteinuria must be ≤1g\u002F24hour)\n* Life expectancy ≥ 3 months\n* Women of childbearing potential must agree to use a highly effective method of contraception during the trial and for at least 15 months after discontinuation of the experimental treatments. Men who have sexual relations with women of childbearing potential must agree to use contraception during treatment and for at least 12 months after discontinuation of the experimental treatments\n* Ability of the patient to understand, sign and date the information note and informed consent form before any study specific procedures\n* Patient affiliated to a social security scheme\n* Available tumor sample and pathology report for collection\n\nExclusion Criteria:\n\n* \\- Patients who have received more than one prior systemic therapy\n* FOLFIRINOX Regimen +\u002F- targeted therapy in the first line setting\n* Unknown RAS status\n* BRAF V600E mutated tumor\n* MSI\u002FdMMR tumor\n* Known brain metastasis\n* Known peritoneal carcinomatosis if there are signs of clinical occlusion or sub-occlusion\n* History of gastric ulceration, or myocardial infarction, or severe coronaropathy or severe cardiac dysfunction, within the past 6 months prior to treatment start\n* Patients with dihydropyrimidine dehydrogenase deficiency (uracilemia ≥ 16 ng\u002FmL)\n* Hypersensitivity to one of the study drugs or one of its excipients\n* Inability to swallow capsules\n* Live attenuated vaccines 30 days prior to treatment start\n* Untreated bone fracture\n* Significant haemorrhagic diathesis or coagulopathy (in the absence of anti-coagulant treatment)\n* Major surgery, open biopsy or major traumatic lesion in the prior 30 days or the need for major surgery during the trial\n* Pregnant or breastfeeding woman or patients with no adequate contraception\n* Known Uridine Diphosphate Glucuronyltransferase (UGT1A1) deficiency or known Gilbert disease\n* Strong inducers of CYP3A4 (treatment with St John's Wort (Hypericum perforatum), fampicin, phenobarbital, primidone, phenytoin and carbamazepine)\n\n  \\-- Strong inhibitors of CYP3A4, continuous use of azole antifungals (posaconazole, voriconazole, itraconazole, isavuconazole), ritonavir, verapamil, diltiazem, grapefruit juice (equivalent to half a fresh grapefruit\u002Fday)\n* Concomitant or recent treatment with sorivudine or its analogs (including brivudine) within 4 weeks prior to the administration of protocol treatment (related to Fluorouracil)\n* Concomitant treatment with phenytoin or its analogs\n* QT\u002FQTc interval \\> 450 ms for men and \\> 470 ms for women\n* Uncontrolled hypertension (defined as systolic blood pressure \\>140 mmHg and\u002For diastolic blood pressure \\>90 mmHg) or history of hypertensive crisis (TA systolic\\> 20 mmHg) or hypertensive encephalopathy\n* History of veinous thromboembolic events, including deep vein thrombosis and pulmonary embolism, within the past month prior to study enrollment\n* History of stroke and\u002For transient ischemic attack (TIA) within the past 12 months\n* Residual Oxaliplatin neuropathy (grade ≥ 2) counter indicates FOLFOX administration\n* Persistence of clinically significant symptoms after a thromboembolic event despite anticoagulant treatment\n* Arterial thromboembolism (myocardial infarction, stroke, transient ischemic attack) occurring under antiangiogenic therapy\n* Other active cancers or history of cancer treated within the last 5 years except for carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma or any other carcinoma in situ, considered cured\n* Persons deprived of liberty or under guardianship or unable of giving consent\n* Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons","80 Years",{"count":167,"type":20},74,[79],"The standard second-line treatment for metastatic colorectal cancer (mCRC) involves chemotherapy (FOLFOX or FOLFIRI) combined with an antiangiogenic agent, such as bevacizumab or aflibercept. Maintaining VEGF inhibition between first and second-line treatments has shown modest clinical benefits, with exploratory analyses suggesting that bevacizumab is more effective in smaller tumors. The ULYSSE trial aims to evaluate the efficacy and safety of Fruquintinib, a potent antiangiogenic agent, combined with a doublet chemotherapy (FOLFOX or FOLFIRI) in second-line treatment for BRAF wild-type, MSS mCRC patients who have failed prior treatment.",[29],"2025-09-01",{"date":173,"type":37},"2025-09-08",{"date":175,"type":20},"2025-12-31",{"date":177,"type":20},"2028-10-31",{"name":179,"class":95},"Federation Francophone de Cancerologie Digestive",45,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":15,"minAge":189,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100596279","streamlining-radioembolization-for-ccc-and-metastatic-liver-cancer-100596279","NCT07043387","Streamlining Radioembolization for CCC and Metastatic Liver Cancer","Streamlining Radioembolization for Cholangiocarcinoma or Metastatic Liver Cancer ≤ 7 cm : Multicenter Prospective Registry Study","ISTAR-03","Inclusion Criteria:\n\n* Adult aged 19 and over\n\n  * metastatic liver cancer or cholangiocarcinoma\n\n    * the diameter of the largest tumor ≤ 7cm, tumor number 5 or less\n\n      * FLR volume \\> 30% of total non-tumorous liver volume\n\n        * Dysmorphic intratumoral vessel : absent, if present, 3mm or thinner ⑥ Child-Pugh class A\n\n          * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 ⑧ No major organ dysfunction according to blood test performed within two months of study enrollment A. Leukocytes ≥ 1,000\u002FµL and ≤ 20,000\u002FµL B. Hemoglobin ≥ 6.0 g\u002FdL (transfusion allowed to meet this criterion) C. Total bilirubin ≤ 2.0 mg\u002FdL D. Platelet ≥ 40,000\u002FµL E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants F. Aspartate transaminase (AST) ≤ 800 IU\u002FL (i.e., ≤ 20X upper normal limit) G. Alanine transaminase (ALT) ≤ 800 IU\u002FL (i.e., ≤ 20X upper normal limit) H. Creatinine ≤ 2.5 mg\u002FdL (If patients is undergoing hemodialysis, no limit of creatinine) ⑨ Patients with a life expectancy of more than 3 months ⑩ For women of childbearing age, a negative serum pregnancy test. ⑪ Patients who have adequately understood the clinical trial and consented in writing\n\nExclusion Criteria:\n\n* hepatic vein invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI)\n* Hepatic vein enhancement on arterial phase CT\u002FMRI\n* dysmorphic intratumoral vessel \\> 3mm on arterial phase CT\u002FMRI\n* TIPS is present\n* Lobar portal vein enhancement on arterial phase CT\u002FMRI due to AP shunt\n* main portal vein tumor thrombosis\n* Cases where the operator judges that the occurrence of even mild radiation pneumonitis could be fatal, based on marked emphysema or interstitial lung disease findings on chest CT\n* biliary stent or bilioenteric anastomosis\n* History of severe allergy of intolerance to contrast agents\n* Contraindication to angiography or selective visceral catheterization","19 Years",{"count":191,"type":20},60,"TARE uses radioactive microspheres (20-60 μm), which are trapped in tumors due to abnormal vasculature, while normal liver sinusoids (≤15 μm) prevent their passage. However, some microspheres may drain into hepatic veins and reach the lungs, risking radiation pneumonitis. Pre-procedural evaluation with angiography and nuclear imaging (MAA scan with SPECT\u002FCT) is required to calculate lung shunt fraction (LSF). TARE is contraindicated if LSF \\>20%, and may be used with caution if LSF is 10-20%.\n\nFindings associated with high LSF include large tumors, hepatic vein invasion, TIPS, and dysmorphic intratumoral vessels. In contrast, small or medium sized (\\\u003C7 cm) cholangiocarcinoma or metastatic liver cancers without hepatic vein invasion or dysmorphic vessels show consistently low LSF (\\\u003C5%). Over 10 years at SNUH, no cases of radiation pneumonitis have been observed in such patients. Therefore, \"streamlining TARE\" omits pre-procedural nuclear imaging for this group to reduce procedural delays, reserving nuclear imaging for patients who need it most.\n\nSIR-Spheres (SIRTEX) facilitate single-session TARE as they are provided in a bulk vial, unlike TheraSphere which requires advance preparation based on dosimetry.\n\nProtocol Overview :\n\nProcedure: Same-day angiography, cone-beam CT, and TARE using SIR-Spheres.\n\nDosimetry: Lung shunt fraction is assumed as 5%, estimated lung dose is capped at 10 Gy.\n\nTumor dose goal: 80\\~400 Gy (around 250Gy)(single-compartment MIRD), or 300 \\~ 1000 Gy (multi-compartment MIRD). minimal tumor dose by partition dosimetry : 100Gy\n\nSoftware: Simplicit90Y for planning, Y90 PET\u002FCT the next day for post-treatment dosimetry.\n\nFollow-up: 1 year; additional treatments follow institutional guidelines.\n\nThis streamlined approach maximizes efficiency while maintaining safety in selected patients.",[29,194,195],"Metastatic Liver Cancer","Cholangiocarcinoma","2025-07-21",{"date":198,"type":37},"2025-07-24",{"date":200,"type":37},"2025-06-22",{"date":202,"type":20},"2029-06-30",{"name":204,"class":95},"Seoul National University Hospital",4]