[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635185":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":64,"centralContacts":69,"locations":80,"responsibleParty":99,"collaborators":74,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":74,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":82,"whyStopped":74,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy","EXPERIMENTAL","The neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with four cycles of the mFOLFOX6 regimen, PD-1 monoclonal antibody, and molecularly targeted drugs (selected based on RAS status; patients with RAS\u002FBRAF wild-type receive cetuximab, while those with RAS\u002FBRAF mutations receive bevacizumab). After completing the first cycle of mFOLFOX6 chemotherapy combined with targeted and immune therapy, patients undergo SCRT at a dose of 5Gy × 5 fractions. At least 7 days after the completion of radiotherapy, patients continue with three additional cycles of mFOLFOX6 chemotherapy combined with PD-1 monoclonal antibody and targeted drugs (bevacizumab is not used in the last cycle of the bevacizumab group). Surgery is performed 8-10 weeks after the completion of SCRT.",[13,14,15,16,17,18],"Radiation: Short-Course Radiotherapy","Drug: PD-1 monoclonal antibody","Drug: mFOLFOX6 regimen","Drug: Cetuximab","Drug: Bevacizumab","Procedure: Surgical resection",{"label":20,"type":21,"description":22,"interventionNames":23},"SCRT + mFOLFOX6","ACTIVE_COMPARATOR","The neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with four cycles of the mFOLFOX6 regimen. After completing the first cycle of mFOLFOX6 chemotherapy, patients undergo SCRT at a dose of 5Gy × 5 fractions. At least 7 days after the completion of radiotherapy, patients continue with three additional cycles of mFOLFOX6 chemotherapy. Surgery is performed 8-10 weeks after the completion of SCRT.",[13,15,18],[25,32,39,45,51,57],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"RADIATION","Short-Course Radiotherapy","Patients undergo SCRT at a dose of 5Gy × 5 fractions",[20,9],[31],"SCRT",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","PD-1 monoclonal antibody","Patients complete immune therapy with PD-1 monoclonal antibody for 4 cycles.",[9],[38],"PD-1",{"type":33,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"mFOLFOX6 regimen","Patients complete chemotherapy with mFOLFOX6 regimen for 4 cycles.",[20,9],[44],"mFOLFOX6",{"type":33,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Cetuximab","Patients with RAS\u002FBRAF wild-type receive targeting therapy with Cetuximab for 4 cycles.",[9],[50],"Cetuximab Antibody",{"type":33,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Bevacizumab","Patients with RAS\u002FBRAF mutations receive targeting therapy with Bevacizumab for 3 cycles. (Bevacizumab is not used in the last cycle of the bevacizumab group)",[9],[56],"Bevacizumab Antibody",{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"PROCEDURE","Surgical resection","Surgery either local excition or total mesorectal excision is performed 8-10 weeks after the completion of short-course radiotherapy.",[20,9],[63],"Surgery",[65],{"name":66,"affiliation":67,"role":68},"Jun Huang, PhD","Sun Yat-sen University","PRINCIPAL_INVESTIGATOR",[70,76],{"name":71,"role":72,"phone":73,"phoneExt":74,"email":75},"Jun Huang, PhD.","CONTACT","+8613926451242",null,"huangj97@mail.sysu.edu.cn",{"name":77,"role":72,"phone":78,"phoneExt":74,"email":79},"Fang He, MD.","+8618826059789","hefang23@mail.sysu.edu.cn",[81],{"facility":5,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"RECRUITING","Guangzhou","Guangdong","510065","China","CN",{"type":89,"coordinates":90},"Point",[91,92],113.25,23.11667,{"lat":92,"lon":91},[95],{"name":96,"role":72,"phone":97,"phoneExt":74,"email":98},"Jun Hu","+86-020-38379764","zslyllb@mail.sysu.edu.cn",{"type":68,"investigatorFullName":100,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":74,"oldOrganization":74},"Jun Huang","Professor","100635185","phase-3-scrt--chemo-targeted-immuno-neoadjuvant-therapy-for-high-risk-pmmrmss-rc-100635185",false,"NCT07549399","SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR\u002FMSS RC","Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS\u002FBRAF Wild-Type)\u002FBevacizumab (for RAS\u002FBRAF Mutant) in High-Risk pMMR\u002FMSS Rectal Adenocarcinoma: a Phase III Randomized Controlled Trial","CRITⅡ","Inclusion Criteria:\n\n1. Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulations and institutional guidelines.\n2. Age 18-75 years.\n3. Histologically or cytologically confirmed pMMR\u002FMSS rectal adenocarcinoma; all other histological types are excluded.\n4. Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.\n5. Clinical staging with high-risk factors, including cT3Nx, EMVI(+), or cT4, ±MRF(+), ±EMVI(+).\n6. No evidence of distant metastasis before treatment.\n7. No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).\n8. ECOG performance status of 0-1.\n9. Peripheral blood counts and liver and kidney function within the following allowable ranges (tested within 15 days before the start of treatment):\n\n   * White blood cells (WBC) ≥3.0×10\\^9\u002FL or absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n\n     * Hemoglobin (HGB) ≥80 g\u002FL; ③Platelets (PLT) ≥100×10\\^9\u002FL; ④Liver transaminases (AST\u002FALT) \\\u003C3.0 times the upper limit of the normal range; ⑤Total bilirubin (TBIL) \\\u003C1.5 times the upper limit of the normal range; ⑥Creatinine (CREAT) \\\u003C1.5 times the upper limit of the normal range.\n10. No history of other malignancies; not pregnant or breastfeeding, and effective contraception must be used during the study period and for 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with a history of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);\n2. Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;\n3. A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;\n4. Severe electrolyte abnormalities;\n5. Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or tumors with active bleeding that have not been resected; or other conditions that may lead to gastrointestinal bleeding or perforation; or gastrointestinal perforation that has not healed after surgical treatment;\n6. History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months; or patients receiving high-dose anticoagulation therapy;\n7. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants and their partners who are unwilling to strictly practice contraception during the study period;\n8. Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for more than 3 years, or in situ cancers that can be cured with adequate treatment);\n9. Presence of severe ECG abnormalities or active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or New York Heart Association (NYHA) Class II or higher congestive heart failure;\n10. Patients with active infections (infections causing fever above 38°C);\n11. Patients with uncontrolled hypercalcemia, hypertension, or diabetes;\n12. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n13. Patients with psychiatric disorders that may affect clinical treatment or a history of central nervous system diseases;\n14. Patients with severe complications (bowel obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);\n15. Presence of any CTCAE Grade 2 or higher toxicity caused by previous treatments that has not resolved (excluding anemia, alopecia, and skin pigmentation);\n16. Any unstable medical condition that may affect patient safety and compliance with the study;\n17. Patients deemed by the investigator as unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":114,"type":115},204,"ESTIMATED","INTERVENTIONAL",[118],"PHASE3","To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS\u002FBRAF status: cetuximab for wild-type, bevacizumab for mutant) and a PD-1 monoclonal antibody, compared with short-course radiotherapy followed by mFOLFOX6 chemotherapy alone, in high-risk locally advanced pMMR\u002FMSS rectal adenocarcinoma through a prospective, randomized controlled phase III clinical study, providing high-level evidence-based medical evidence to establish a superior neoadjuvant treatment strategy for this population.",[121,122,123],"Rectal Adenocarcinoma","High-Risk Cancer","MSS",[27,125,126],"Targeting Therapy","Immunotherapy","2026-06-29",{"date":129,"type":130},"2026-07-01","ACTUAL",{"date":132,"type":130},"2026-05-20",{"date":134,"type":115},"2029-04-30",{"name":5,"class":6},1]