[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651804":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":74,"centralContacts":83,"locations":93,"responsibleParty":111,"collaborators":87,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":87,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":136,"overallStatus":140,"whyStopped":87,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",[8,17,23,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Short-Course Radiotherapy + mFOLFOX6 + PD-1","SHAM_COMPARATOR","The neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with 6 cycles of the mFOLFOX6 regimen and PD-1 monoclonal antibody. Initially, patients undergo SCRT at a dose of 5Gy × 5 fractions. At least 7 days after the completion of radiotherapy, patients complete 6 cycles of mFOLFOX6 chemotherapy combined with PD-1 monoclonal antibody at two-week intervals. Surgery is performed 2 weeks after the completion of the last cycle of chemotherapy.",[13,14,15,16],"Radiation: Short-Course Radiotherapy","Drug: PD-1 monoclonal antibody","Combination Product: mFOLFOX6 regimen","Procedure: Surgical resection",{"label":18,"type":19,"description":20,"interventionNames":21},"Short-Course Radiotherapy + mFOLFOX6 + PD-1 + Ketogenic Diet","EXPERIMENTAL","The neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with 6 cycles of the mFOLFOX6 regimen, PD-1 monoclonal antibody and daily ketogenic diet. Initially, patients undergo SCRT at a dose of 5Gy × 5 fractions. After completing radiotherapy, patients initiate a ketogenic dietary intervention and, at least 7 days later, receive six cycles of mFOLFOX6 chemotherapy combined with a PD-1 monoclonal antibody at two-week intervals. The ketogenic dietary intervention continues until the completion of neoadjuvant treatment. Surgery is performed 2 weeks after the completion of the last cycle of chemotherapy.",[13,14,15,22,16],"Behavioral: Ketogenic Diet",{"label":24,"type":19,"description":25,"interventionNames":26},"Short-Course Radiotherapy + mFOLFOX6 + PD-1 + Vitamin C","The neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with 6 cycles of the mFOLFOX6 regimen, PD-1 monoclonal antibody and Vitamin C. Initially, patients undergo SCRT at a dose of 5Gy × 5 fractions. At least 7 days after the completion of radiotherapy, patients complete 6 cycles of mFOLFOX6 chemotherapy combined with PD-1 monoclonal antibody and at two-week intervals, together with intravenous vitamin C at 1.5 g\u002Fkg\u002Fday on three consecutive days (Days 1-3) of each cycle. Surgery is performed 2 weeks after the completion of the last cycle of chemotherapy.",[13,14,15,16,27],"Drug: Vitamin C",{"label":29,"type":19,"description":30,"interventionNames":31},"Short-Course Radiotherapy + mFOLFOX6 + PD-1 + Ketogenic Diet + Vitamin C","The neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with 6 cycles of the mFOLFOX6 regimen, PD-1 monoclonal antibody, Vitamin C and daily ketogenic diet. Initially, patients undergo SCRT at a dose of 5Gy × 5 fractions. After completing radiotherapy, patients initiate a ketogenic dietary intervention and, at least 7 days later, receive six cycles of mFOLFOX6 chemotherapy combined with a PD-1 monoclonal antibody at two-week intervals, together with intravenous vitamin C at 1.5 g\u002Fkg\u002Fday on three consecutive days (Days 1-3) of each cycle. The ketogenic dietary intervention continues until the completion of neoadjuvant treatment. Surgery is performed 2 weeks after the completion of the last cycle of chemotherapy.",[13,14,15,22,16,27],[33,40,47,54,61,68],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"RADIATION","Short-Course Radiotherapy","Patients undergo SCRT at a dose of 5Gy × 5 fractions",[9,18,29,24],[39],"SCRT",{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","PD-1 monoclonal antibody","Patients receive six cycles of immunotherapy with serplulimab injection, a PD-1 monoclonal antibody, at a fixed dose of 200 mg per cycle.",[9,18,29,24],[46],"PD-1",{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"COMBINATION_PRODUCT","mFOLFOX6 regimen","Patients receive six cycles of the mFOLFOX6 regimen, consisting of oxaliplatin (85 mg\u002Fm²) and leucovorin (200 mg\u002Fm²) administered intravenously over 2 hours, followed by a bolus of fluorouracil (400 mg\u002Fm²) and a continuous infusion of fluorouracil (2,400 mg\u002Fm²) over 46 hours.",[9,18,29,24],[53],"mFOLFOX6",{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"BEHAVIORAL","Ketogenic Diet","A modified Atkins diet (MAD) is used, with the goal of maintaining nutritional ketosis, defined as a blood β-hydroxybutyrate (BHB) level of 1.5-3.0 mmol\u002FL. The ketogenic dietary intervention begins after completion of SCRT and continues throughout six cycles of mFOLFOX6 chemotherapy and immunotherapy until the completion of neoadjuvant treatment.",[18,29],[60],"Modified Atkins Diet",{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"PROCEDURE","Surgical resection","Surgery either local excition or total mesorectal excision is performed 2 weeks after the completion of neoadjuvant therapy.",[9,18,29,24],[67],"Surgery",{"type":41,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Vitamin C","Vitamin C is administered intravenously at a dose of 1.5 g\u002Fkg\u002Fday, diluted in 250-500 mL of normal saline, over 2 hours for 3 consecutive days (Days 1-3). Each treatment cycle is repeated every 2 weeks and synchronized with the neoadjuvant treatment cycle.",[29,24],[73],"VitC",[75,79],{"name":76,"affiliation":77,"role":78},"Jun Huang, PhD.","6th Affliated Hospital of Sun Yat-sen University","STUDY_CHAIR",{"name":80,"affiliation":81,"role":82},"Guohui Wan, PhD.","School of Pharmaceutical Sciences, Sun Yat-Sen University","PRINCIPAL_INVESTIGATOR",[84,89],{"name":76,"role":85,"phone":86,"phoneExt":87,"email":88},"CONTACT","+8613926451242",null,"huangj97@mail.sysu.edu.cn",{"name":90,"role":85,"phone":91,"phoneExt":87,"email":92},"Fang He, MD.","+8618826059789","hefang23@mail.sysu.edu.cn",[94],{"facility":5,"status":87,"city":95,"state":96,"zip":87,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Guangzhou","Guangdong","China","CN",{"type":100,"coordinates":101},"Point",[102,103],113.25,23.11667,{"lat":103,"lon":102},[106,109],{"name":107,"role":85,"phone":108,"phoneExt":87,"email":88},"Jun Huang, MD","+86-13926451242",{"name":80,"role":110,"phone":87,"phoneExt":87,"email":87},"SUB_INVESTIGATOR",{"type":82,"investigatorFullName":112,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":87,"oldOrganization":87},"Jun Huang","Professor","100651804","phase-2-nct--pd1--ketogenic-diet-andor-vitamin-c-for-larc-100651804",false,"NCT07765667","NCT + PD1 + Ketogenic Diet and\u002For Vitamin C for LARC","Neoadjuvant Chemoradiotherapy and Immunotherapy Combined With Ketogenic Diet and\u002For High-Dose Intravenous Vitamin C in pMMR\u002FMSS Locally Advanced Rectal Adenocarcinoma: A Prospective, Multicenter, Phase Ⅱ Clinical Study (CRI-KEV Trial)","CRI-KEV","Inclusion Criteria:\n\n1\\. Histologically confirmed rectal adenocarcinoma. 2. Age 18-80 years. 3. Immunohistochemical examination of biopsy specimens indicating proficient mismatch repair (pMMR), or microsatellite-stable (MSS) status.\n\n4\\. Clinical stage cT3-T4N0 or cTxN+. 5. The lower margin of the rectal tumor is ≤10 cm from the anal verge. 6. No distant metastases, as confirmed by contrast-enhanced CT of the chest, abdomen, and pelvis and pelvic MRI before treatment.\n\n7\\. No evidence of intestinal obstruction, or resolution of obstruction following diverting stoma surgery.\n\n8\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 9. Adequate peripheral blood counts and hepatic and renal function, as defined by the following laboratory values measured within 15 days before treatment initiation:\n\n* White blood cell count (WBC) ≥3.0 × 10⁹\u002FL or absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL;\n* Hemoglobin (HGB) ≥80 g\u002FL;\n* Platelet count (PLT) ≥100 × 10⁹\u002FL;\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C3.0 × the upper limit of normal (ULN);\n* Total bilirubin (TBIL) \\\u003C1.5 × ULN;\n* Serum creatinine (CREAT) \\\u003C1.5 × ULN. 10. No prior chemotherapy or radiotherapy. 11. No prior treatment with biological agents (e.g., monoclonal antibodies), immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies), or other investigational agents.\n\n  12\\. Not pregnant or breastfeeding. Participants must use effective contraception during the study and for 6 months after the final dose of study treatment.\n\n  13\\. Written informed consent has been provided. Exclusion Criteria\n  1. Arrhythmia requiring antiarrhythmic therapy, except for beta-blockers or digoxin; symptomatic coronary artery disease; myocardial ischemia, including myocardial infarction within the previous 6 months; or congestive heart failure greater than New York Heart Association (NYHA) class II.\n  2. Severe hypertension that is inadequately controlled with medication.\n  3. A history of human immunodeficiency virus (HIV) infection or active chronic hepatitis B or C infection with a high viral DNA copy number.\n  4. Active tuberculosis (TB), current anti-tuberculosis treatment, or receipt of anti-tuberculosis treatment within 1 year before screening.\n  5. Other active, clinically serious infections according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.\n  6. Preoperative evidence of distant metastases outside the pelvis.\n  7. Cachexia or decompensated organ function.\n  8. Prior pelvic or abdominal radiotherapy.\n  9. Multiple primary colorectal cancers.\n  10. Confirmed glucose-6-phosphate dehydrogenase (G6PD) deficiency.\n  11. Seizures requiring treatment, such as corticosteroid or antiepileptic therapy.\n  12. A history of another malignancy within the previous 5 years, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin.\n  13. Substance abuse or any medical, psychological, or social condition that may interfere with participation in the study or the evaluation of study results.\n  14. Any active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonitis, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, or hypothyroidism. Participants with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be enrolled; participants with asthma requiring medical intervention with bronchodilators are excluded.\n  15. Receipt of any vaccine against an infectious disease, such as an influenza or varicella vaccine, within 4 weeks before enrollment.\n  16. A concomitant condition requiring long-term immunosuppressive therapy or systemic or topical corticosteroids at immunosuppressive doses, defined as \\>10 mg\u002Fday of prednisone or an equivalent corticosteroid.\n  17. Gastrointestinal disorders, such as an active gastric or duodenal ulcer, ulcerative colitis, or an unresected tumor with active bleeding; any other condition that may cause gastrointestinal bleeding or perforation; or an unhealed gastrointestinal perforation following surgery.\n  18. Known or suspected hypersensitivity to any study drug or to any medication administered in connection with this study.\n  19. Any unstable condition or other circumstance that may compromise participant safety or treatment compliance.\n  20. Pregnant or breastfeeding women, or women of childbearing potential who are not using adequate contraception.\n  21. Refusal to provide written informed consent.","ALL","18 Years","80 Years",{"count":126,"type":127},100,"ESTIMATED","INTERVENTIONAL",[130],"PHASE2","To explore the efficacy and safety of adding a ketogenic diet and\u002For high-dose intravenous vitamin C to neoadjuvant short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with serplulimab in patients with locally advanced pMMR\u002FMSS rectal adenocarcinoma through a prospective, randomized, controlled phase II clinical study, providing preliminary evidence for optimizing neoadjuvant treatment strategies for this population.",[133,134,135],"Rectal Adenocarcinoma","High-Risk Cancer","MSS",[137,138,35,56,139],"Targeting Therapy","Immunotherapy","High-dose Intravenous Vitamin C","NOT_YET_RECRUITING","2026-08-11",{"date":143,"type":144},"2026-08-14","ACTUAL",{"date":146,"type":127},"2026-09-01",{"date":148,"type":127},"2029-09-01",{"name":5,"class":6},1]