[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545708":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":29,"responsibleParty":46,"collaborators":18,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":18,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":18,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":32,"whyStopped":18,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"The Second Hospital of Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Colonic local administration of fluorouracil with enhanced adhesion","EXPERIMENTAL","Fluorouracil is administered via the colon as an injectable solution at a dose of 500 mg per day for 6 days, along with poloxamer 407 and poloxamer 188 used as thermosensitive hydrogel to enhance adhesion.",[13],"Drug: Colonic local administration of fluorouracil with enhanced adhesion",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],null,[20],{"name":21,"affiliation":22,"role":23},"Faming Zhang, MD, PhD","Department of Microbiota Medicine & Medical Center for Digestive Diseases","PRINCIPAL_INVESTIGATOR",[25],{"name":21,"role":26,"phone":27,"phoneExt":18,"email":28},"CONTACT","86-025-58509883","fzhang@njmu.edu.cn",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"The Second Affiliated Hospital of Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","210011","China","CN",{"type":39,"coordinates":40},"Point",[41,42],118.77778,32.06167,{"lat":42,"lon":41},[45],{"name":21,"role":26,"phone":18,"phoneExt":18,"email":18},{"type":23,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Faming Zhang","Vice President","100545708","phase-2-fluorouracil-treatment-via-colon-for-colorectal-cancer-100545708",false,"NCT06385418","Fluorouracil Treatment Via Colon for Colorectal Cancer","Fluorouracil Treatment Via Colon for Colorectal Cancer: an Exploratory Study","Inclusion Criteria:\n\n1. Chinese individuals aged 18 to 75 years, both male and female;\n2. Histologically confirmed diagnosis of colorectal cancer with measurable primary lesion according to RECIST 1.1;\n3. ECOG performance status ≤2;\n4. Expected survival of more than 3 months;\n5. Multidisciplinary team consensus that the patient is suitable for adding local chemotherapy to the established tumor treatment regimen;\n6. Adequate organ function meeting the following criteria: (1) Absolute neutrophil count ≥1.5 × 10\\^9\u002FL, platelets ≥100 × 10\\^9\u002FL, hemoglobin ≥90 g\u002FL; (2) Total bilirubin ≤1.5 times the upper limit of normal (patients with biliary drainage via retrograde techniques included); ALT and AST ≤5 times the upper limit of normal, and for patients with liver metastases, serum total bilirubin less than or equal to 3 times the upper limit of the normal reference range; (3) Creatinine \\\u003C120 μmol\u002FL, or MDRD estimated glomerular filtration rate \\>60 mL\u002Fmin; (4) Doppler echocardiography assessment: Left ventricular ejection fraction (LVEF) ≥50%;\n7. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment, and sexually active men or women agree to use appropriate contraception during the trial and for 8 weeks after the last dose of investigational drug;\n8. Suitable physical condition and personal willingness to undergo colonic transendoscopic enteral tubing;\n9. Willingness to cooperate with physicians, and agree to regular follow-up visits and examinations as recommended after completion of treatment;\n10. Agreement to specimen collection and voluntary signing of a written informed consent form.\n\nExclusion Criteria:\n\n1. Uncontrolled cardiovascular diseases, such as congestive heart failure (NYHA III-IV), coronary artery disease, cardiomyopathy, arrhythmias, or hemodynamic instability at enrollment, with a risk of significant events during the treatment period;\n2. Active severe clinical infections (≥ Grade 2 according to NCI-CTCAE version 5.0), including fungal, viral, or tuberculosis infections within the gastrointestinal tract;\n3. Coagulation abnormalities with bleeding tendencies (who do not meet the criteria of having a normal INR without the use of anticoagulants within 14 days prior to enrollment). Participants receiving anticoagulants or vitamin K antagonists such as warfarin or heparin are excluded unless their international normalized ratio (INR) is ≤1.5, with allowance for low-dose warfarin (1 mg orally once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for prophylaxis;\n4. History of immunodeficiency or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;\n5. Known progressive or actively treated other malignancies requiring intervention, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ;\n6. Presence of other serious diseases that would render the subject ineligible for enrollment as determined by the investigator;\n7. Breastfeeding women;\n8. Known allergy or intolerance to the investigational drug or its excipients;\n9. Participation in another drug clinical trial within the past four weeks;\n10. Lack of legal capacity or restricted legal capacity.","ALL","18 Years","75 Years",{"count":60,"type":61},40,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","Fluorouracil (5-FU) is a commonly used drug for colorectal cancer (CRC). Thermosensitive hydrogel presents a promising carrier for 5-FU to address challenges encountered with traditional administration methods. We propose an integrated approach utilizing colonic transendoscopic enteral tubing to cover the entire colon flexibly, coupled with a thermo-sensitive gel to enhance the adhesion of 5-FU. This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for treating CRC.",[67],"Colorectal Cancer",[69,70,71,67],"Fluorouracil","Transendoscopic enteral tubing","Thermosensitive hydrogel","2024-06-25",{"date":74,"type":75},"2024-06-26","ACTUAL",{"date":77,"type":75},"2024-05-16",{"date":79,"type":61},"2029-05-01",{"name":5,"class":6},1]