[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605330":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":46,"centralContacts":50,"locations":55,"responsibleParty":74,"collaborators":11,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":11,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":103,"whyStopped":11,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"First Affiliated Hospital of Chongqing Medical University","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Involve-site Short-Course Radiotherapy","EXPERIMENTAL",null,[13,14],"Radiation: Reduced-field short-course radiotherapy","Drug: Immunotherapy combined with chemotherapy",{"label":16,"type":17,"description":11,"interventionNames":18},"Standard long-course radiotherapy","ACTIVE_COMPARATOR",[19,20],"Radiation: Standard long-course radiotherapy","Drug: Chemotherapy",{"label":22,"type":17,"description":11,"interventionNames":23},"Standard short-course radiotherapy",[14,24],"Radiation: Standard short-course radiotherapy",[26,31,36,39,42],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"RADIATION","Reduced-field short-course radiotherapy","A dose of 25 Gy in 5 fractions was delivered as short-course radiotherapy, with one fraction per day, completing treatment within one week. The target volume was delineated using both CT and MRI. Compared to conventional radiotherapy fields, the irradiated volume was significantly reduced to include only the primary tumor and any metastatic lymph nodes as identified on MRI and CT.",[9],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"DRUG","Immunotherapy combined with chemotherapy","After completion of radiotherapy, chemotherapy with the XELOX regimen (oxaliplatin 130 mg\u002Fm² on day 1 plus capecitabine 1500 mg\u002Fm² on days 1-14, every 3 weeks) was initiated in combination with sintilimab immunotherapy (200 mg every 3 weeks) for 4 cycles.",[9,22],{"type":27,"name":22,"description":37,"armGroupLabels":38,"otherNames":11},"\"Patients in the standard short-course radiotherapy group will receive 25 Gy in 5 fractions, once daily. Target volumes will be delineated according to the 2023 Guidelines for Target Volume Delineation and Planning of Rectal Cancer (National Cancer Center\u002FNational Cancer Quality Control Center), including the primary tumor, mesorectal region, and internal iliac and obturator lymph node drainage areas.\"",[22],{"type":27,"name":16,"description":40,"armGroupLabels":41,"otherNames":11},"Patients in the standard long-course radiotherapy group will receive 50 Gy in 25 fractions, once daily, five days per week, with concurrent oral capecitabine chemotherapy. Target volumes will be delineated according to the 2023 Guidelines for Target Volume Delineation and Planning of Rectal Cancer (National Cancer Center\u002FNational Cancer Quality Control Center), including the primary tumor, mesorectal region, and internal iliac and obturator lymph node drainage areas.",[16],{"type":32,"name":43,"description":44,"armGroupLabels":45,"otherNames":11},"Chemotherapy","Two weeks after the completion of radiotherapy, patients will receive four cycles of CAPOX chemotherapy.",[16],[47],{"name":48,"affiliation":5,"role":49},"Longhao Li, M.D.","STUDY_CHAIR",[51],{"name":48,"role":52,"phone":53,"phoneExt":11,"email":54},"CONTACT","+86-02389011516","llh@hospital.cqmu.edu.cn",[56],{"facility":57,"status":11,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"The First Affiliated Hospital of Chongqing Medical University","Chongqing","Chongqing Municipality","400016","China","CN",{"type":64,"coordinates":65},"Point",[66,67],106.55771,29.56026,{"lat":67,"lon":66},[70],{"name":71,"role":52,"phone":72,"phoneExt":11,"email":73},"Qing Yan","+86 023-89011876","149276764@qq.com",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Longhao Li","M.D.","100605330","phase-2-involve-site-radiotherapy-combined-with-chemotherapy-and-immunotherapy-as-neoadjuvant-treatment-for-locally-advanced-rectal-cancer-100605330",false,"NCT07161115","Involve-site Radiotherapy Combined With Chemotherapy and Immunotherapy as Neoadjuvant Treatment for Locally Advanced Rectal Cancer","A Phase II Study Evaluating the Efficacy and Safety of Neoadjuvant Therapy With MRI-Guided Involve-site Short-Course Radiotherapy Combined With Immunotherapy and Chemotherapy for Locally Advanced Rectal Cancer","REFIRT","Inclusion Criteria:\n\n* Voluntarily agrees to participate and provides written informed consent\n* Age 18 to 75 years, male or female\n* Histologically confirmed rectal adenocarcinoma\n* MRI confirms that the upper margin of the tumor is ≤12 cm from the anal verge\n* ECOG performance status of 0-1\n* Clinical stage T3-T4 or N+ and circumferential resection margin (CRM) positive by imaging evaluation; lateral lymph nodes negative\n* Immunohistochemistry or genetic testing indicates pMMR or MSS status\n* Adequate organ function and bone marrow reserve\n\nExclusion Criteria:\n\n* Presence of distant metastasis\n* Prior pelvic radiotherapy\n* Chemotherapy or immunotherapy within the past 3 months\n* Refusal to undergo radical surgery for rectal cancer\n* Concurrent active malignancy other than rectal cancer\n* Positive antinuclear antibody (ANA)\n* History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis)\n* Elevated troponin above the normal range\n* Active tuberculosis\n* Positive hepatitis B surface antigen (HBsAg) or detectable HBV DNA\n* Positive for hepatitis C virus (HCV), syphilis, or HIV\n* Severe comorbid conditions (e.g., serious infection, severe bone marrow suppression, psychiatric disorder) deemed unsuitable for participation by the investigator\n* Pregnant or breastfeeding women\n* Any other contraindications to radiotherapy, chemotherapy, or immunotherapy","ALL","18 Years","75 Years",{"count":90,"type":91},60,"ESTIMATED","INTERVENTIONAL",[94],"PHASE2","Surgery is the primary treatment for rectal cancer. However, in patients with locally advanced disease, direct surgery often fails to achieve complete tumor resection. In such cases, neoadjuvant therapy is required to downstage the tumor before surgery. The current standard neoadjuvant approach consists of preoperative radiotherapy and then surgery. Although effective, standard radiotherapy uses large target volumes, which results in significant toxicities, increased surgical complications, and reduced patient compliance and quality of life. In addition, excessive radiation fields can compromise the intensity and timing of systemic therapy, potentially increasing the risk of distant metastasis. This may be one of the key reasons why current neoadjuvant radiotherapy mainly improves local control but has not translated into prolonged overall survival.\n\nEmerging evidence suggests that combining immunotherapy with radiotherapy may further enhance treatment efficacy. However, large radiation fields may impair the effectiveness of immunotherapy. Therefore, reducing the radiotherapy target volume may not only decrease treatment-related toxicity but also augment the immunotherapy response.\n\nThis clinical study is designed to evaluate whether reducing the radiotherapy target volume, when combined with chemotherapy and immunotherapy prior to surgery, can decrease radiotherapy-related toxicities and reduce the risk of distant metastasis, without increasing the local recurrence rate, compared with the current standard radiotherapy fields. The ultimate goal is to improve the efficacy of neoadjuvant therapy in locally advanced rectal cancer while minimizing treatment toxicity, thereby providing new strategies and evidence for preoperative management.",[97],"Rectal Adenocarcinoma",[99,100,101,102],"rectal cancers","radiotherapy","immunotherapy","Reducing the radiation field for radiotherapy","NOT_YET_RECRUITING","2025-09-12",{"date":106,"type":107},"2025-09-15","ACTUAL",{"date":109,"type":91},"2025-09-19",{"date":111,"type":91},"2030-08-31",{"name":76,"class":6},1]