[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597330":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":50,"centralContacts":54,"locations":60,"responsibleParty":75,"collaborators":29,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":29,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":29,"enrollmentInfo":86,"targetDuration":29,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":29,"overallStatus":63,"whyStopped":29,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Hebei Medical University Fourth Hospital","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Involve-field radiotherapy-TNT+Camrelizumab","EXPERIMENTAL","Patients received Involve-field radiotherapy (25Gy\u002F5f, including the primary rectal tumor, metastatic or suspected pelvic lymph nodes, mesorectal, and presacral regions). Four cycles of CAPOX plus Carilizumab were given to patients 1-2 weeks after chemoradiotherapy completion.\n\nPatients were evaluated 2-3 weeks after the end of treatment. Patients who met the cCR criteria could choose to undergo surgical treatment or not. For patients who did not meet the cCR criteria, surgical treatment was recommended. For patients who refused surgery, the patients in the trial group continued to receive 4 cycles of CAPOX chemotherapy combined with camrelizumab.",[13,14,15,16],"Drug: Camrelizumab","Drug: CAPOX","Radiation: Involve-field irradiation","Procedure: TME surgery",{"label":18,"type":6,"description":19,"interventionNames":20},"Elective nodal irradiation-TNT","Patients received elective nodal long-course concurrent chemoradiotherapy (50.4 Gy\u002F28f). Capecitabine (825 mg\u002Fm² bid) was administered orally on radiotherapy days. Four cycles of CAPOX were given to patients 1-2 weeks after chemoradiotherapy completion.\n\nPatients were evaluated 2-3 weeks after the end of treatment. Patients who met the cCR criteria could choose to undergo surgical treatment or not. For patients who did not meet the cCR criteria, surgical treatment was recommended. For patients who refused surgery, the patients in the trial group continued to receive 4 cycles of CAPOX chemotherapy.",[21,14,22,16],"Drug: Capecitabine","Radiation: Elective nodal irradiation",[24,30,34,37,42,46],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Capecitabine","Capecitabine: 825mg\u002Fm2, bid;",[18],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Camrelizumab","Camrelizumab: 200mg",[9],{"type":25,"name":35,"description":35,"armGroupLabels":36,"otherNames":29},"CAPOX",[18,9],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"RADIATION","Involve-field irradiation","Involve-field irradiation: Primary rectal tumor + metastatic or suspicious pelvic lymph nodes, mesorectal region, and presacral region",[9],{"type":38,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Elective nodal irradiation","Elective nodal irradiation: Large pelvic field",[18],{"type":47,"name":48,"description":48,"armGroupLabels":49,"otherNames":29},"PROCEDURE","TME surgery",[18,9],[51],{"name":52,"affiliation":5,"role":53},"Fengpeng Wu","PRINCIPAL_INVESTIGATOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":29,"email":59},"Fengpeng Wu, Professor","CONTACT","15032818011","wfpzhj@126.com",[61],{"facility":62,"status":63,"city":64,"state":29,"zip":29,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"the Fourth Hospital of Hebei Medical University","RECRUITING","Shijiazhuang","China","CN",{"type":68,"coordinates":69},"Point",[70,71],114.47861,38.04139,{"lat":71,"lon":70},[74],{"name":52,"role":57,"phone":29,"phoneExt":29,"email":59},{"type":76,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100597330","phase-2-involved-field-radiotherapy-tnt-combined-with-pd-1-inhibitor-for-pmmr-locally-advanced-rectal-cancer-neo-field-i-100597330",false,"NCT07057089","Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I)","Clinical Exploration of Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer: a Prospective, Open-label, Randomized Controlled Trial (Neo-Field I)","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n3. Pathologic diagnosis of adenocarcinoma of the rectum, definite pMMR type;\n4. Clinical staging of T3-4NanyM0 or T1-2N+M0 (based on AJCC 8th edition staging criteria);\n5. The lower margin of the primary tumor is located below the peritoneal reflex or the lower margin of the tumor is ≤10 cm from the anal verge;\n6. Pre-enrollment laboratory indicators meet the following indicator ranges： 1)Blood: absolute neutrophils ≥1.5×10\\^9\u002FL, platelets ≥100×10\\^9\u002FL, hemoglobin ≥90g\u002FL; 2)Liver and kidney function: ALT\u002FAST ≤ 2.5 x ULN, total bilirubin ≤ 1.5 x ULN, creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60mL\u002Fmin (Cockcroft-Gault formula)； 3)Coagulation: INR ≤ 1.5, APTT ≤ 1.5 x ULN (for those not receiving anticoagulation)；\n7. Women or men of childbearing potential need to agree to use effective contraception during the study and for 6 months after the last treatment session;\n8. Voluntary written informed consent and commitment to complete the full treatment and follow-up program.\n\nExclusion Criteria:\n\n1. Pathologic type is other specific types such as neuroendocrine carcinoma, squamous carcinoma, etc;\n2. Previous radiotherapy, chemotherapy, targeted or immunotherapy for rectal cancer;\n3. Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis requiring long-term immunosuppressive therapy)；\n4. Presence of active infection (e.g. HIV, HBV\u002FHCV viral load positive requiring stabilization on antiretroviral therapy)；\n5. Severe cardiovascular disease (e.g., myocardial infarction within 6 months, unstable angina, uncontrolled hypertension \\>160\u002F100 mmHg)；\n6. History of other malignant tumors (except non-melanoma skin cancers, cervical cancer in situ, etc. cured for ≥5 years)；\n7. Uncontrolled diabetes mellitus (HbA1c \\> 8%), abnormal thyroid function (TSH outside normal range and requiring pharmacologic intervention)；\n8. Severe chronic bowel disease (e.g., Crohn's disease, active ulcerative colitis)； Patients deemed by the investigator to be unsuitable for participation in this study.","ALL","18 Years",{"count":87,"type":88},90,"ESTIMATED","INTERVENTIONAL",[91],"PHASE2","The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.",[94],"Locally Advanced Rectal Cancer","2025-08-11",{"date":97,"type":98},"2025-08-14","ACTUAL",{"date":100,"type":98},"2025-07-01",{"date":102,"type":88},"2030-12-01",{"name":5,"class":6},1]