[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643076":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":22,"locations":10,"responsibleParty":28,"collaborators":10,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":34,"sex":40,"minAge":41,"maxAge":10,"enrollmentInfo":42,"targetDuration":45,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":53,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":10},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Cohort (NOM\u002FOPFS)",null,"Retrospective Cohort Study: Patients who achieved cCR\u002Fnear-cCR after neoadjuvant immunotherapy and entered the \"Watch \\& Wait\" (W\\&W) program, as well as those with near-cCR or non-cCR who underwent local excision (LE) or endoscopic resection (including Endoscopic Submucosal Dissection \\[ESD\\] or Endoscopic Mucosal Resection \\[EMR\\]).\n\nProspective Registry Study: Patients eligible for and consenting to NOM or OPFS. This includes the W\\&W strategy for those achieving cCR\u002Fnear-cCR, and LE or endoscopic resection (ESD\u002FEMR) for those with near-cCR or non-cCR.",[13],"Other: NOM\u002FOPFS",{"label":15,"type":10,"description":16,"interventionNames":10},"Control Cohort (RO)","Retrospective Cohort Study: Patients who underwent radical surgical operation after neoadjuvant immunotherapy. Pathological outcomes (including the proportions of ypCR, ypTisN0, and ypT1-2N0) and surgical safety data will be collected and analyzed.\n\nProspective Registry Study: Patients who proceed to standard radical operation. Pathological response distribution (proportions of ypCR, ypTisN0, ypT1-2N0, and ypT3+ diseases) and short-to-long-term surgical safety endpoints will be prospectively documented.",[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"NOM\u002FOPFS","Patients eligible for and consenting to NOM or OPFS. This includes the W\\&W strategy for those achieving cCR\u002Fnear-cCR, and LE or endoscopic resection (ESD\u002FEMR) for those with near-cCR or non-cCR.",[9],[23],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"Xiaokang Lei, M.D.","CONTACT","+8618811181993","lxkpku@163.com",{"type":29,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Xiaokang Lei","Dr.","100643076","safety-and-efficacy-of-nom-and-opfs-versus-ro-for-dmmrmsi-h-or-pole-mutated-gastrointestinal-cancers-100643076",false,"NCT07642323","Safety and Efficacy of NOM and OPFS Versus RO for dMMR\u002FMSI-H or POLE-Mutated Gastrointestinal Cancers","Safety and Efficacy of Nonoperative Management (NOM) and Organ Preservation First Strategy (OPFS) Versus Radical Operation (RO) for dMMR\u002FMSI-H or POLE-Mutated Gastrointestinal Cancers: A Single-Center, Bidirectional Registry Study","NOR-MP","Inclusion Criteria:\n\n* Histologically confirmed primary gastrointestinal adenocarcinoma or squamous cell carcinoma (e.g., colorectal cancer, gastric cancer, gastroesophageal junction cancer).\n* Confirmed as deficient mismatch repair (dMMR) by immunohistochemistry (IHC), high microsatellite instability (MSI-H) by polymerase chain reaction (PCR) or next-generation sequencing (NGS), or harboring POLE exonuclease domain mutations.\n* Received neoadjuvant\u002Fconversion immunotherapy (immune checkpoint inhibitors, either monotherapy or combination therapy) prior to treatment response evaluation.\n* For the Retrospective Cohort (Part 1): Patients treated between \\[Start Month\u002FYear\\] and \\[End Month\u002FYear\\] who completed evaluation and subsequent strategy (NOM\u002FOPFS or RO).\n* For the Prospective Cohort (Part 2): Newly diagnosed patients who consent to long-term follow-up and multi-disciplinary team (MDT) assessment for organ preservation or radical surgery.\n* Age ≥ 18 years at the time of diagnosis.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Concurrently diagnosed with other active malignant tumors within the past 5 years.\n* Patients with proficient mismatch repair (pMMR) \u002F microsatellite stable (MSS) tumors, or wild-type POLE status.\n* Evidence of untreatable distant metastasis or systemic disease that precludes local tumor management (NOM\u002FOPFS or radical operation).\n* Inability to undergo regular endoscopic, radiological (MRI\u002FCT), or clinical follow-up due to compliance or geographic reasons.\n* Refusal to sign the informed consent form (applicable to the prospective cohort).","ALL","18 Years",{"count":43,"type":44},22,"ESTIMATED","3 Years","OBSERVATIONAL","Purpose:\n\nThe purpose of this study is to evaluate the safety and efficacy of Non-Operative Management (NOM) and Organ Preservation First Strategy (OPFS) compared with Radical Operation (RO) in patients with deficient mismatch repair\u002Fmicrosatellite instability-high (dMMR\u002FMSI-H) or POLE-mutated gastrointestinal cancers.\n\nBackground \\& Design:\n\nWith the remarkable efficacy of neoadjuvant immunotherapy in dMMR\u002FMSI-H or POLE-mutated gastrointestinal tumors, organ preservation has become a promising alternative to highly invasive surgeries. The NOR-MP trial is a single-center, bidirectional registry study consisting of two parts: a retrospective cohort study and a prospective observational registry.\n\nIntervention Group (NOM\u002FOPFS): Patients who achieve a clinical complete response (cCR) or near-cCR after neoadjuvant immunotherapy will undergo a \"Watch \\& Wait\" (W\\&W) strategy. Patients with near-cCR or non-cCR who are eligible for organ preservation will undergo local excision (LE) or endoscopic resection (including ESD or EMR).\n\nComparison Group (Radical Operation): Patients who undergo standard radical surgical resection after neoadjuvant immunotherapy.\n\nThe study aims to determine whether an organ-preserving approach can achieve comparable oncological outcomes and safety profiles while significantly improving patients' quality of life compared to radical surgery.",[49,50,51,52],"Gastrointestinal Cancers","Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Anus",[54,55,56],"Gastrointestinal cancers","Colorectal cancer","Gastric cancer","NOT_YET_RECRUITING","2026-06-06",{"date":60,"type":61},"2026-06-11","ACTUAL",{"date":63,"type":44},"2026-07-15",{"date":65,"type":44},"2030-01-15",{"name":5,"class":6}]