[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-colon-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-colon-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,74],{"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":4},"100633611","application-of-3d-reconstruction-for-preoperative-strategy-of-locally-advanced-colon-cancer-100633611",false,"NCT07528937","Application of 3D Reconstruction for Preoperative Strategy of Locally Advanced Colon Cancer","Randomized Multicenter Study Protocol: Application of 3D Reconstruction for Preoperative Strategy of Locally Advanced Colon Cancer","Inclusion Criteria:\n\n1. Patients of both sexes, aged ≥18 years.\n2. Adenocarcinoma of the right, left, sigmoid and recto-sigmoid junction that have cT3 or cT4a\u002Fb according to the eighth TNM edition of the American Joint Committee on Cancer (AJCC). Pre-treatment diagnosis by imaging (CT) test.\n3. Lymph node extension: cN0, the presence of cN1\u002F2 according to AJCC TNM 8th edition is allowed as long as they can be resected. Pretreatment diagnosis by imaging (CT) test.\n4. Patients who access and sign informed consent for the surgical intervention.\n\nExclusion Criteria:\n\n1. Suspected carcinomatosis on preoperative CT or intraoperative finding\n2. Suspected distant metastasis on preoperative CT or intraoperative finding\n3. Patients with tumors with infiltration considered to be unresectable (pre-surgical or intraoperatively), since the anatomical-pathological analysis will not be available.","ALL","18 Years",{"count":19,"type":20},168,"ESTIMATED","INTERVENTIONAL",[23],"NA","The aim of this study is to assess the usefulness of a mathematical model of three-dimensional image process and reconstuction (3D-IPR) as a surgical planner in locally advanced colon cancer. In addition to comparing the diagnostic accuracy of this planner with that of the CT regarding the infiltration of neighbouring structures.",[26,27,28],"Colon Neoplasms","Locally Advanced Colon Cancer","3D Reconstruction",[30,31,28],"Locally advanced colon cancer","Colon neoplasm","NOT_YET_RECRUITING","2026-04-16",{"date":35,"type":36},"2026-04-21","ACTUAL",{"date":38,"type":20},"2026-05-01",{"date":40,"type":20},"2031-05-01",{"name":42,"class":43},"Fundació d'investigació Sanitària de les Illes Balears","OTHER_GOV",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100561786","phase-2-node-sparing-short-course-radiation-with-capox-and-sintilimab-for-mss-locally-advanced-colon-cancer-a-randomized-prospective-multicenter-study-100561786","NCT06594692","Node-Sparing Short-Course Radiation With CAPOX and Sintilimab for MSS Locally Advanced Colon Cancer: A Randomized, Prospective, Multicenter Study","Node-sparing Modified Short-Course Radiation Combined With CAPOX and Sintilimab for MSS Locally Advanced Colon Cancer : A Randomized, Prospective, Multicenter, Open-label Clinical Trial","mRCAT-C","Inclusion Criteria:\n\n* 1\\. Patients willing to undergo neoadjuvant treatment. 2. Age ≥ 18 years. 3. Tumor confirmed by colonoscopy and enhanced abdominal CT to be ≥ 12 cm from the anal verge.\n\n  4\\. Histologically diagnosed adenocarcinoma; genetic testing indicates MSI-L or MSS, or immunohistochemistry from tumor biopsy shows pMMR (all four proteins-MSH1, MSH2, MSH6, and PMS2-are positive).\n\n  5\\. Clinical staging by enhanced abdominal CT evaluates as cT3-4N0-2M0. 6. ECOG performance status score of 0-1. 7. No prior treatment with anti-tumor, immunotherapy, or abdominal radiation therapy before enrollment.\n\n  8\\. Blood test results (without transfusion within 14 days and no use of granulocyte colony-stimulating factor or other hematopoietic stimulators within 7 days before the lab test):\n  1. White blood cell count ≥ 3.5 × 10\\^9\u002FL, absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL, platelet count ≥ 100 × 10\\^9\u002FL, hemoglobin concentration ≥ 9 g\u002FdL;\n  2. Liver function tests (bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 5 × ULN);\n  3. Renal function (serum creatinine ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL\u002Fmin);\n  4. Coagulation (INR ≤ 1.5 × ULN, PT and APTT ≤ 1.5 × ULN);\n  5. Thyroid function: TSH ≤ upper limit of normal (ULN); if abnormal, FT3 and FT4 levels must be evaluated, and if FT3 and FT4 are normal, the patient is eligible.\n\n     9\\. Voluntary participation with a signed informed consent form.\n\n     Exclusion Criteria:\n* 1\\. History of other malignancies within the past 5 years. 2. Patients with metastases in other locations (stage IV). 3. Patients with MSI-H or dMMR. 4. Patients with conditions such as bowel obstruction, perforation, or bleeding requiring emergency surgery.\n\n  5\\. Known allergy to the study drug or any of its excipients. 6. Patients with any unstable systemic diseases, including but not limited to severe infections, uncontrolled diabetes, uncontrolled hypertension, unstable angina, cerebrovascular accidents or transient ischemic attacks, myocardial infarction, congestive heart failure, or severe illnesses requiring medication (such as arrhythmias, liver, kidney, or metabolic diseases) that are life-threatening.\n\n  7\\. History of active autoimmune diseases requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within the last 2 years. Replacement therapies (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatments.\n\n  8\\. Known history of HIV infection or acquired immunodeficiency syndrome (AIDS). 9. Receipt of any investigational drug (including immunotherapy) or participation in another interventional clinical study within 30 days before screening.\n\n  10\\. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study; men or women unwilling to use effective contraception during the study.\n\n  11\\. Vulnerable populations, including those with mental illness, cognitive impairment, or critically ill patients.\n\n  12\\. Any other conditions deemed inappropriate for participation by the investigator.",{"count":53,"type":20},140,[55],"PHASE2","This study aims to evaluate the use of node-sparing short-course radiotherapy combined with chemotherapy and Sintilimab, or chemotherapy alone, as neoadjuvant therapy for MSS-type locally advanced colon cancer. The goal is to explore the efficacy and safety of combining node-sparing short-course radiotherapy with chemotherapy and immunotherapy in the neoadjuvant setting for MSS-type locally advanced colon cancer, while also investigating the specific role of regional lymph nodes in tumor immunotherapy.",[58,27],"Microsatellite Stable (MSS) Colon Cancer",[27,58,60,61,62],"Node-Sparing Radiotherapy","Short-Course Radiotherapy","Sintilimab","2024-09-10",{"date":65,"type":36},"2024-09-19",{"date":67,"type":20},"2024-10",{"date":69,"type":20},"2026-09-30",{"name":71,"class":72},"Sir Run Run Shaw Hospital","OTHER",2,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100295442","phase-3-perioperative-versus-postoperative-capox-chemotherapy-for-locally-advanced-colon-cancer-100295442","NCT03125980","Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer","Perioperative CapeOX Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Resectable Colon Cancer: An Open Label Randomized Controlled Phase III Trial","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2;\n* Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count≥1.5×109\u002FL, Platelet count≥100×109\u002FL, Hemoglobin≥80g\u002FL, Serum bilirubin≤24umol\u002FL, Alanine aminotransferase and aspartate aminotransferase ≤ 60×IU\u002FL, Serum creatinine≤110 umol\u002FL;\n* No current pregnancy or breast-feeding, and subjects at childbearing age shall take method of contraception ;\n* Be in a condition to receive a surgery\u002Fprocedure;\n* No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;\n* No previous systemic chemotherapy for treating colon cancer;\n* No other chemotherapy at the same time;\n* Expected lifetime longer than three months;\n* Be willing and able to understand the study and to provide written informed consent.\n\nExclusion Criteria:\n\n* End-stage cachexia patients;\n* Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate CapeOX chemotherapy;\n* Metastatic carcinoma;\n* Moderate or above anemia caused by serious local tumor bleeding;\n* Incomplete or complete intestinal obstruction;\n* Known to be allergic to oxaliplatin or capecitabine;\n* Active hepatitis, severe coagulation disorder patients;\n* Pregnant or lactating women; or women who have fertility but have not taken at taken adequate contraceptive measures;\n* Known to have deficient dihydropyrimidine dehydrogenase (DPD)；\n* Have vital organ failure or other severe diseases, including but not limited to coronary heart disease, cardiovascular diseases, or myocardial infarction within 12 months before being included; severe neurological or psychiatric history；severe infection; active disseminated intravascular coagulation;\n* Unable or unwilling to abide by the study plan.","75 Years",{"count":83,"type":20},1370,[85],"PHASE3","Adjuvant chemotherapy has been widely adopted worldwide for locally advanced colon cancer. However, more and more studies have found better efficacy and potential advantages of perioperative or neoadjuvant chemotherapy. The sooner the systemic chemotherapy is received, the better suppression it has on activity of tumor growth factors. Pre-operative chemotherapy may eliminate tiny metastases. It may also shrink the invasion of tumor before surgery, and thus reducing operational trauma and expediting recovery. With advances in radiology and tomography, staging before surgery is accurate enough to identify risks and prognosis for patients. The phase II trial conducted by our department has yielded encouraging results (N=47, CapeOX regimen, clinicaltrials.gov NCT02415829): after the neoadjuvant chemotherapy, no subject had disease progression, 68.1% subjects reached complete or partial response. Besides, the toxicity of neoadjuvant CapeOX chemotherapy was acceptable. The present randomized controlled phase III trial will be conducted to further compare efficacy and safety of the neoadjuvant and adjuvant CapeOX chemotherapy for patients with locally advanced resectable colon cancer in China. This study may have two periods, each will last for approximately 5 years. After the first period (n=994), if the results of the test group are better than the control group, the study will be terminated. Otherwise, the study will enter into period 2 (n=376) through selecting out genetically sensitive subjects and repeating the same trial process as period 1.",[27],"RECRUITING","2017-04-19",{"date":91,"type":36},"2017-04-24",{"date":93,"type":20},"2017-05",{"date":95,"type":20},"2027-05",{"name":97,"class":72},"Fudan University",1]