[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658097":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":33,"interventions":57,"overallOfficials":85,"centralContacts":90,"locations":98,"responsibleParty":112,"collaborators":26,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":26,"eligibilityCriteria":120,"healthyVolunteers":117,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":26,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":26,"overallStatus":136,"whyStopped":26,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"complete response (CR) rate","Defined as pathological complete response (pCR) + Clinical complete response (cCR)","an expected average of 12 months",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"3-year disease-Free Survival","The time from the first day of disease free (operation date) to local or distant recurrence, or the death event caused by any reason, whichever occurs first","an expected average of 3 years",{"measure":19,"description":20,"timeFrame":21},"Overall Survival","The time from the date of randomization to the death caused by any cause","an expected average of 5 years",{"measure":23,"description":24,"timeFrame":25},"Adverse events (AEs) were graded according to the NCI CTCAE version 5·0","Adverse events and surgical safety","an expected average of 1.5 years",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE",[34,45,49,53],{"label":35,"type":36,"description":37,"interventionNames":38},"Arm A","EXPERIMENTAL","β-HB-Positive (β-HB Elevation significantly)\n\n* Radiation: Short-course radiotherapy (SCRT): 25 Gy delivered in 5 fractions over 1 week.\n* Chemotherapy: 6 cycles of CAPEOX (Capecitabine 1000 mg\u002Fm² PO BID D1-14 + Oxaliplatin 130 mg\u002Fm² IV D1, q3w) at investigator's discretion.\n* PD-1 Inhibitor: Approved anti-PD-1 monoclonal antibody, administered on Day 1 of each chemotherapy cycle for 6 cycles. Dose may be delayed for immune-related adverse events (irAEs) (max delay ≤6 weeks).\n* Procedure: Restaging after 6 cycles; TME surgery or Watch \\& Wait strategy per multidisciplinary evaluation.",[39,40,41,42,43,44],"Radiation: Short-course radiotherapy","Drug: Capecitabine","Drug: Oxaliplatin","Procedure: TME surgery","Drug: PD -1\u002FPD-L1 monoclonal antibody","Other: Watch & Wait strategy",{"label":46,"type":36,"description":47,"interventionNames":48},"Arm B","β-HB-Positive (β-HB Elevation significantly)\n\n* Radiation: Short-course radiotherapy (SCRT): 25 Gy delivered in 5 fractions over 1 week.\n* Chemotherapy: 6 cycles of CAPEOX (Capecitabine 1000 mg\u002Fm² PO BID D1-14 + Oxaliplatin 130 mg\u002Fm² IV D1, q3w) at investigator's discretion.\n* Procedure: Restaging after 6 cycles; TME surgery or Watch \\& Wait strategy per multidisciplinary evaluation.",[39,40,41,42,44],{"label":50,"type":36,"description":51,"interventionNames":52},"Arm C","β-HB-Negative (β-HB no Elevation)\n\n* Radiation: Short-course radiotherapy (SCRT): 25 Gy delivered in 5 fractions over 1 week.\n* Chemotherapy: 6 cycles of CAPEOX (Capecitabine 1000 mg\u002Fm² PO BID D1-14 + Oxaliplatin 130 mg\u002Fm² IV D1, q3w) at investigator's discretion.\n* PD-1 Inhibitor: Approved anti-PD-1 monoclonal antibody, administered on Day 1 of each chemotherapy cycle for 6 cycles. Dose may be delayed for immune-related adverse events (irAEs) (max delay ≤6 weeks).\n* Procedure: Restaging after 6 cycles; TME surgery or Watch \\& Wait strategy per multidisciplinary evaluation.",[39,40,41,42,43,44],{"label":54,"type":36,"description":55,"interventionNames":56},"Arm D","β-HB-Negative (β-HB no Elevation)\n\n* Radiation: Short-course radiotherapy (SCRT): 25 Gy delivered in 5 fractions over 1 week.\n* Chemotherapy: 6 cycles of CAPEOX (Capecitabine 1000 mg\u002Fm² PO BID D1-14 + Oxaliplatin 130 mg\u002Fm² IV D1, q3w) at investigator's discretion.\n* Procedure: Restaging after 6 cycles; TME surgery or Watch \\& Wait strategy per multidisciplinary evaluation.",[39,40,41,42,44],[58,63,68,72,77,81],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":26},"RADIATION","Short-course radiotherapy","Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy.",[35,46,50,54],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":26},"DRUG","Capecitabine","1000mg\u002Fm2, bid, po, d1-14,q3w",[35,46,50,54],{"type":64,"name":69,"description":70,"armGroupLabels":71,"otherNames":26},"Oxaliplatin","130mg\u002Fm2, ivgtt, d1,q3w",[35,46,50,54],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":26},"PROCEDURE","TME surgery","The surgery was performed 1 week after the end of neoadjuvant therapy.",[35,46,50,54],{"type":64,"name":78,"description":79,"armGroupLabels":80,"otherNames":26},"PD -1\u002FPD-L1 monoclonal antibody","200 mg via intravenous infusion every 3 weeks (q3w) for 6 cycles, initiated 1 week after radiotherapy completion.",[35,50],{"type":6,"name":82,"description":83,"armGroupLabels":84,"otherNames":26},"Watch & Wait strategy","The Watch \\& Wait (W\\&W) strategy is an organ-preserving clinical management approach for patients with locally advanced rectal cancer who achieve a clinical complete response (cCR) after neoadjuvant therapy. In this strategy, definitive surgical resection (total mesorectal excision, TME) is withheld, and patients are instead managed with a standardized, intensive surveillance regimen to monitor for disease regrowth.",[35,46,50,54],[86],{"name":87,"affiliation":88,"role":89},"Zhenyu Lin","Huazhong University of Science and Technology Tongji Medical College Union Hospital","PRINCIPAL_INVESTIGATOR",[91,95],{"name":87,"role":92,"phone":93,"phoneExt":26,"email":94},"CONTACT","15827130393","whxhlzy@hust.edu.cn",{"name":96,"role":92,"phone":26,"phoneExt":26,"email":97},"Tao Zhang","taozhangxh@hust.edu.cn",[99],{"facility":100,"status":26,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":26},"Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430000","China","CN",{"type":107,"coordinates":108},"Point",[109,110],114.26667,30.58333,{"lat":110,"lon":109},{"type":113,"investigatorFullName":96,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Clinical Professor","100658097","phase-2-a-prospective-biomarker-stratified-phase-2-study--hydroxybutyrate-as-a-predictive-biomarker-for-short-course-radiotherapy-followed-by-chemotherapy-plus-pd-1-inhibitor-versus-chemotherapy-alone-in-locally-advanced-rectal-cancer-100658097",false,"NCT07847229","A Prospective, Biomarker-Stratified Phase 2 Study: β-Hydroxybutyrate as a Predictive Biomarker for Short-Course Radiotherapy Followed by Chemotherapy Plus PD-1 Inhibitor Versus Chemotherapy Alone in Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n1. Patients or their family members agree to participate in the study and sign the informed consent form;\n2. Age 18-75 years, male or female;\n3. Histologically confirmed Locally Advanced rectal adenocarcinoma;\n4. inferior margin ≤ 10 cm from the anal verge;\n5. ECOG performance status score is 0-1;\n6. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc;\n7. There was no operative contraindication;\n8. Laboratory tests were required to meet the following requirements: white blood cell (WBC) ≥ 4×109\u002FL; Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; Platelet count ≥ 100×109\u002FL; Hemoglobin ≥90 g\u002FL; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50 mL\u002Fmin; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n9. Urinary protein \\\u003C 2+ or 24-hour urinary protein excretion \\\u003C 1 g at baseline.\n\nExclusion Criteria:\n\n1. Patients with non-pMMR LARC；\n2. Subjects who have previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other treatment targeting tumor immunomodulatory mechanisms;\n3. Presence of any concurrent disease, condition (including laboratory abnormality), history of substance abuse, or current evidence thereof, which, in the judgment of the Investigator, may compromise subject safety, interfere with the process of obtaining informed consent, affect subject compliance, or confound the safety assessment of the investigational product(s).","ALL","18 Years","75 Years",{"count":125,"type":126},144,"ESTIMATED","INTERVENTIONAL",[129],"PHASE2","This is a prospective, single-arm, biomarker-stratified, multicenter phase 2 clinical trial. All enrolled patients first receive short-course radiotherapy (SCRT), followed by measurement of serum β-hydroxybutyrate (β-HB) levels to calculate the post-radiotherapy elevation rate. Patients are stratified into an β-HB-positive stratum (elevation significantly) and an β-HB-negative stratum (no elevation), then randomized 1:1 within each stratum to receive either perioperative chemotherapy plus PD-1 inhibitor or perioperative chemotherapy alone.\n\nThe primary endpoint is the complete response (CR) rate, defined as the composite of pathological complete response (pCR) and clinical complete response (cCR). The study aims to evaluate the efficacy and safety of adding PD-1 inhibitor to perioperative chemotherapy in LARC, and to validate post-radiotherapy β-HB elevation as a predictive biomarker for immunotherapy benefit.",[132,133,134,135],"Rectal Cancer","Radiotherapy","Immunotherapy","Chemotherapy","NOT_YET_RECRUITING","2026-10-01",{"date":139,"type":140},"2026-10-06","ACTUAL",{"date":142,"type":126},"2026-11-01",{"date":144,"type":126},"2028-04-30",{"name":96,"class":6},1]