[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658603":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":40,"interventions":50,"overallOfficials":33,"centralContacts":68,"locations":33,"responsibleParty":76,"collaborators":33,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":33,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":33,"studyType":93,"phases":94,"briefSummary":95,"conditions":96,"keywords":33,"overallStatus":98,"whyStopped":33,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":33},{"fullName":5,"class":6},"Tang-Du Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"pCR rate","The pCR rate and its 95 % confidence interval were calculated","At the time of surgical resection, 4 to 6 weeks after completion of neoadjuvant therapy'",[14,18,22,26,29],{"measure":15,"description":16,"timeFrame":17},"safety analysis","The incidence of adverse events and its 95 % confidence interval were calculated. Adverse events were summarized according to the classification of system organs.","From first study drug administration through 30 days after surgery",{"measure":19,"description":20,"timeFrame":21},"Analysis of objective remission rate","ORR and its 95 % confidence interval were calculated","Up to 6 weeks after completion of neoadjuvant therapy, prior to surgery",{"measure":23,"description":24,"timeFrame":25},"R0 resection rate analysis","The R0 resection rate and its 95 % confidence interval were calculated","On the day of surgery",{"measure":27,"description":28,"timeFrame":25},"Analysis of anal preservation rate","The anal sphincter preservation rate and its 95 % confidence interval were calculated",{"measure":30,"description":31,"timeFrame":32},"MMR \u002F MSI status and PD-L1 expression level","The correlation between biomarkers such as MMR \u002F MSI status and PD-L1 expression level and treatment response was analyzed","Two weeks after operation",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NA","SINGLE_GROUP","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"Intervention group","EXPERIMENTAL","Serplulimab combined with bevacizumab plus XELOX (oxaliplatin + capecitabine) as neoadjuvant therapy for locally advanced rectal cancer",[46,47,48,49],"Drug: Serplulimab","Drug: Bevacizumab","Drug: Oxaliplatin","Drug: Capecitabine",[51,56,60,64],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":33},"DRUG","Serplulimab","Intravenous infusion, 300 mg, Day 1 of every 3-week cycle, neoadjuvant treatment",[42],{"type":52,"name":57,"description":58,"armGroupLabels":59,"otherNames":33},"Bevacizumab","Intravenous infusion, 7.5 mg\u002Fkg, Day 1 of every 3-week cycle, neoadjuvant treatment",[42],{"type":52,"name":61,"description":62,"armGroupLabels":63,"otherNames":33},"Oxaliplatin","Intravenous infusion, 130 mg\u002Fm², Day 1 of every 3-week cycle, XELOX regimen",[42],{"type":52,"name":65,"description":66,"armGroupLabels":67,"otherNames":33},"Capecitabine","Oral administration, 1000 mg\u002Fm² twice daily, Day 1 to Day 14 of every 3-week cycle, XELOX regimen",[42],[69,74],{"name":70,"role":71,"phone":72,"phoneExt":33,"email":73},"Nan Wang, Ph.D","CONTACT","02984777431","wangnandoc@163.com",{"name":75,"role":71,"phone":33,"phoneExt":33,"email":33},"Nan Wang",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Wang Nan","Chairman of the Department of General Surgery, Chief Physician, Professor","100658603","a-prospective-single-center-phase-ii-study-of-neoadjuvant-serplulimab-plus-xelox-and-bevacizumab-in-locally-advanced-rectal-cancer-100658603",false,"NCT07854964","A Prospective, Single-center, Phase II Study of Neoadjuvant Serplulimab Plus XELOX and Bevacizumab in Locally Advanced Rectal Cancer","A Prospective, Single-center, Phase II Study of Serplulimab Combined With XELOX and Bevacizumab Neoadjuvant Therapy for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* 1\\. Written informed consent must be signed before any trial-related procedures are performed.\n* 2\\. Male or female, aged ≥18 years and ≤75 years.\n* 3\\. Histologically or pathologically confirmed rectal adenocarcinoma, with confirmed proficient mismatch repair (pMMR) or microsatellite stable (MSS) status; diagnosed as locally advanced rectal cancer according to AJCC 9th edition, with cTNM staging as cT2-4N1-3M0 based on contrast-enhanced CT\u002FMRI, and the lesion assessed as resectable by the investigator.\n* 4\\. No prior systemic therapy for the current disease, including surgery, anti-tumor radiotherapy\u002Fchemotherapy, immunotherapy, etc.\n* 5\\. ECOG performance status 0-1.\n* 6\\. Expected survival \\>6 months.\n* 7\\. Adequate organ function, meeting the following laboratory criteria:\n\n  1. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL without granulocyte colony-stimulating factor support within the past 14 days;\n  2. Platelet count ≥100×10\\^9\u002FL without blood transfusion within the past 14 days;\n  3. Hemoglobin \\>9 g\u002FdL without blood transfusion or erythropoietin use within the past 14 days;\n  4. Total bilirubin ≤1.5× upper limit of normal (ULN);\n  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN;\n  6. Serum creatinine ≤1.5× ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 mL\u002Fmin;\n  7. Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN;\n  8. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or free T3) and free T4 within the normal range may also be enrolled;\n  9. Myocardial enzyme levels within the normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator's comprehensive judgment are also allowed for enrollment).\n* 8\\. For female patients who are not postmenopausal or surgically sterile: abstinence or use of effective contraceptive methods during the treatment period and for at least 7 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* 1.Known squamous cell carcinoma, undifferentiated carcinoma, or other histologic types of colorectal cancer, or adenocarcinoma mixed with other histologic types.\n* 2.Known deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) status.\n* 3.Presence of unresectable factors, including unresectability due to tumor-related reasons, presence of surgical contraindications, or subject refusal to undergo surgery.\n* 4.Diagnosis of another malignancy other than colorectal cancer within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For radically resected carcinoma in situ).\n* 5.Current participation in interventional clinical research treatment, or receipt of another investigational drug or use of an investigational device within 4 weeks prior to the first dose.\n* 6.Prior receipt of immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1\u002FL1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, or any other treatment directed at tumor immuno-mechanisms.\n* 7.Severe cardiac disease or conditions, including but not limited to: a confirmed history of heart failure or systolic dysfunction (LVEF \\\u003C50%); uncontrolled high-risk arrhythmias, such as atrial tachycardia, resting heart rate \\>100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular block (i.e., Mobitz II second-degree AV block or third-degree AV block).\n* 8.Poorly controlled hypertension (systolic blood pressure \\>180 mmHg and\u002For diastolic blood pressure \\>100 mmHg).\n* 9.Inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption.\n* 10.Known hypersensitivity to any component of the study drug regimen; history of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.\n* 11.Female patients who are pregnant, breastfeeding, or of childbearing potential with a positive baseline pregnancy test, or women of childbearing potential who are unwilling to use effective contraceptive methods throughout the trial and for at least 7 months after the last dose of study treatment.\n* 12.Presence of serious concomitant disease or other confounding conditions that would interfere with planned treatment, or any other condition that, in the investigator's opinion, makes the subject unsuitable for study participation.","ALL","18 Years","75 Years",{"count":91,"type":92},48,"ESTIMATED","INTERVENTIONAL",[35],"The purpose of this clinical trial is to understand the treatment effects of serplulimab combined with XELOX and bevacizumab as neoadjuvant therapy for locally advanced rectal cancer.\n\n1. What is the effectiveness of this treatment plan for the treatment of locally advanced rectal cancer ?\n2. What is the safety of this treatment for locally advanced rectal cancer ? The type of this study was a single-arm study, and only the patients in the group of Serplulimab combined with XELOX and bevacizumab were observed.\n\nParticipates will\n\n1. The patient underwent four cycles of neoadjuvant therapy with Serplulimab combined with XELOX and bevacizumab (each cycle lasting three weeks).\n2. Preoperative assessment: Imaging evaluation to be conducted within 2-4 weeks after completing neoadjuvant therapy.\n3. Timing of surgery: Perform surgery within 4-6 weeks after completing neoadjuvant therapy.\n4. Surgical method: Choose the appropriate surgical approach (total mesorectal excision, sphincter-preserving or non-sphincter-preserving) based on the tumour location and extent of descent.\n5. Pathological assessment",[97],"Locally Advanced Rectal Cancer","NOT_YET_RECRUITING","2026-10-12",{"date":101,"type":102},"2026-10-13","ACTUAL",{"date":104,"type":92},"2026-10-15",{"date":106,"type":92},"2031-05-15",{"name":5,"class":6}]