[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colon-cancer-stage-i\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colon-cancer-stage-i":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"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":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100624454","phase-2-neoadjuvant-immunotherapy-and-organ-sparing-treatment-in-patients-with-stage-i-iii-dmmr-colon-cancer-100624454",false,"NCT07409844","Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer","Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer: A National, Multicentre, Personalised, Phase II Study (RESET C2)","RESET C2","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Written informed consent\n3. Clinical UICC stage I-III dMMR colon carcinoma\n4. Indication for elective curative-intent surgery\n5. ECOG status 0-2\n\nExclusion Criteria:\n\n1. Patients deemed to be non-surgical candidates by MDT\n2. Patients with a need for emergent surgery due to tumour obstruction\n3. Contraindications to pembrolizumab, including allergy and hypersensitivity reactions, assessed by the study investigator(s)\n4. Any serious or uncontrolled medical disorder, including other malignant disease, that may increase the risk associated with participation or drug administration.\n5. Patients with colonic stents\n\nAdditional Circumstances:\n\nIn the following circumstances, eligibility will be individually verified:\n\n* Synchronous colonic tumours (may be included if other lesions are biopsy-verified with dMMR status)\n* Concurrent tumours (e.g., patients with prostate cancer may be included if this does not hinder their other cancer treatment or assessments of efficacy)\n\nIn the following circumstance patients may be excluded from the PROMs outcomes:\n\n* Danish language skills insufficient to answer PROMs\n* Unable to use eBoks","ALL","18 Years",{"count":20,"type":21},152,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The RESET C2 trial aims to introduce organ sparing treatment or watch-and-wait (WW) to patients with localized deficient mismatch repair (dMMR) colon cancer through use of neoadjuvant pembrolizumab. Patients will be divided into four treatment arms based on their surgical and oncologic risks. Each arm provides different intensity neoadjuvant immunotherapy regimens. Patients with complete response at disease restaging procedures will be offered non-operative management, whereas those with non-complete response will proceed to surgery ± adjuvant chemotherapy as standard of care. A WW protocol with regular disease surveillance continues over survivorship. If there is recurrence, surgery and\u002For appropriate oncologic therapy will be offered determined by multi-disciplinary teams. This is a national, non-randomised, investigator-initiated trial including patients from 13 hospitals across Denmark. The rationale, design, and clinical response metrics are derived from the RESET C study (NCT05662527) showing efficacy, safety and feasibility of neoadjuvant pembrolizumab in this cohort.",[27,28,29,30,31],"DMMR Colorectal Cancer","Colon Cancer Stage I","Colon Cancer Stage II\u002FIII","Pembrolizumab","Immunotherapy",[30,33,34,35,36,37],"dMMR","colon cancer","watch-and-wait","organ sparing","neoadjuvant immunotherapy","NOT_YET_RECRUITING","2026-02-17",{"date":41,"type":42},"2026-02-20","ACTUAL",{"date":44,"type":21},"2026-03-01",{"date":46,"type":21},"2031-01-01",{"name":48,"class":49},"Ismail Gögenur","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":50},"100469584","phase-1-a-phase-i-autologous-ex-vivo-expanded-and-activated-nk-cell-magicell-nk-infusion-for-colon-cancer-post-resection-study-100469584","NCT05394714","A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study","A Dose-Escalating Phase I Study to Determine the Safety, and Maximum Tolerated Dose\u002F Maximum Feasible Dose of Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection","Inclusion Criteria:\n\n1. A dated and signed informed consent\n2. Either gender and aged over 20 years old (inclusive) at date of consent\n3. With histologically confirmed stage I or stage IIa colon cancer\n4. Received curative colon resection within 4\\~8 weeks prior to the screening visit and does not need adjuvant chemotherapy or radiotherapy\n5. With no ≥ grade 3 postoperative complications or has been recovered and is suitable for study enrollment according to the investigator's judgment\n6. With adequate hematology function:\n\n   * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002FμL\n   * Total white blood cell (WBC) ≥ 3,000 cells\u002FμL\n   * Platelets ≥ 100,000 counts\u002FμL\n   * Hemoglobin ≥ 9 g\u002FdL\n7. With adequate hepatic and renal function:\n\n   * Serum creatinine ≤ 1.5 × Upper Limit of Normal (ULN)\n   * Total bilirubin (TB) ≤ 1.5 × ULN\n   * ALT and AST ≤ 2.5 × ULN\n   * Alkaline phosphatase (ALP) ≤ 5X ULN\n8. Negative response in HIV and syphilis test\n9. Subject with childbearing potential must agree to abstain from intercourse or use highly effective contraceptives from when signing informed consent to the Final\u002FET Visit.\n10. Performance status (ECOG) \\\u003C 2\n11. Patients agree to be in compliant to clinical protocol planned treatment plan\n\nExclusion Criteria:\n\n1. Received any other investigational, anti-neoplastic medication (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only), or immune cell therapy within 28 days prior to Day 1.\n2. Currently under immunosuppressive or systemic steroid treatment with equivalent dosage higher than prednisolone 30 mg\u002Fday for more than 7 days within 14 days prior to Day 1\n3. With known tumor metastasis or coexisting malignant disease\n4. With ongoing acute diseases, or within the past 2 years having serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that, judged by the investigator, could interfere with the results of the trial or adversely affect the safety of the subject\n5. Known hypersensitivity to aminoglycoside or bacitracin (e.g. Streptomycin, Gentamicin)\n6. Known hypersensitivity to any of the components of Magicell-NK, including human serum albumin\n7. Female subject who is lactating or has positive urine pregnancy test at screening","20 Years",{"count":60,"type":21},18,[62],"PHASE1","This is a Phase I, open-label study to explore the safety profile and to find the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of Magicell-NK in subjects diagnosed with stage I or stage IIa colon cancer post resection from a single site in Taiwan.\n\nDuring this study, 3 dose levels of Magicell-NK will be tested with a 3+3 design to determine the MTD\u002FMFD: Cohort 1, low dose (2×10\\^8 cells), Cohort 2, middle dose (6×10\\^8 cells), and Cohort 3, high dose (12\\~18 ×10\\^8 cells).",[28],"RECRUITING","2025-09-22",{"date":68,"type":42},"2025-09-23",{"date":70,"type":42},"2022-03-10",{"date":72,"type":21},"2026-12-31",{"name":74,"class":75},"Medigen Biotechnology Corporation","INDUSTRY"]