[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600985":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":56,"collaborators":22,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":22,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":22,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":32,"whyStopped":22,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Affiliated Cancer Hospital of Shantou University Medical College","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Liposomal Irinotecan","EXPERIMENTAL","Treatment regimen:\n\n1. During radiotherapy: Radiotherapy 50Gy\u002F25F + liposomal irinotecan 30mg\u002Fm² ivgtt qw w1-w4 + capecitabine 625mg\u002Fm² Bid, orally on radiotherapy days + tislelizumab 200mg ivgtt q3w;\n2. Radiotherapy-surgery interval: Liposomal irinotecan 70mg\u002Fm² ivgtt q3w + capecitabine 1000mg\u002Fm² Bid D1-D14 q3w + tislelizumab 200mg ivgtt q3w.",[13],"Drug: Liposomal Irinotecan+Tislelizumab+Capecitabine+Rradiotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Liposomal Irinotecan+Tislelizumab+Capecitabine+Rradiotherapy","In this study, the novel drug liposomal irinotecan was added, replacing the conventional formulation of irinotecan, and used as an intensified chemotherapy regimen (liposomal irinotecan + capecitabine) combined with immunotherapy and radiotherapy for neoadjuvant treatment of mid-lower rectal cancer.",[9],[21],"New Neoadjuvant Treatment Approach",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Jiarui Lin","CONTACT","86-13794112671","zljr@163.com",[30,44],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":22},"Shantou University Medical College Cancer Hospital","RECRUITING","Shantou","Guangdong","515000","China","CN",{"type":39,"coordinates":40},"Point",[41,42],116.67876,23.35489,{"lat":42,"lon":41},{"facility":45,"status":46,"city":33,"state":34,"zip":47,"country":36,"countryCode":37,"cosmosGeoPoint":48,"geoPoint":50,"contacts":51},"The First Affiliated Hospital of Shantou University Medical College","NOT_YET_RECRUITING","515041",{"type":39,"coordinates":49},[41,42],{"lat":42,"lon":41},[52],{"name":53,"role":26,"phone":54,"phoneExt":22,"email":55},"Xinxin Li","+86-135-3126-8157","Savageli23@163.com",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Hao-Kai Hu","Clinical Professor，Doctor","100600985","phase-2-study-on-the-efficacy-and-safety-of-neoadjuvant-radiotherapy-combined-with-tislelizumab-liposomal-irinotecan-and-capecitabine-in-the-treatment-of-pmmr-locally-advanced-rectal-adenocarcinoma-with-low-rectal-involvement-100600985",false,"NCT07104604","Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Tislelizumab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally Advanced Rectal Adenocarcinoma With Low Rectal Involvement","Here is the updated format for the \\*\\*Eligibility Criteria\\*\\* with bullet points for each item:\n\nInclusion Criteria:\n\n* Age: 18-75 years, no gender restriction\n* ECOG score 0-1\n* Biopsy-confirmed pMMR (proficient mismatch repair) localized advanced low rectal adenocarcinoma (tumor's lower edge ≤ 10 cm from the anus)\n* Presence of the following high-risk factors: T3N+\u002FT4\u002FN2\u002FEMVI+\u002FMRF+\u002Flateral lymph node metastasis\u002Finability to undergo sphincter-preserving surgery\n* Routine chest and abdominal CT scans showing no distant metastasis\n* Bone marrow function: Neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL, platelet count (PLT) ≥ 100 × 10\\^9\u002FL, hemoglobin (Hb) ≥ 70 g\u002FL\n* Liver function: ALT, AST ≤ 2.5 × ULN (upper limit of normal); total bilirubin ≤ 1.5 × ULN; serum albumin ≥ 3 g\u002FdL\n* Kidney function: Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance ≥ 60 ml\u002Fmin (calculated using the Cockcroft-Gault formula)\n* For females and patients with reproductive potential, a negative pregnancy test must be done within 72 hours before starting the treatment, and the patient must agree to avoid pregnancy during the study treatment and for 6 months after the treatment. For males with reproductive potential partners, the patient must agree to use adequate medically approved contraception during and for 90 days after the final study treatment\n* Patients must agree to receive the study's neoadjuvant chemotherapy regimen and sign an informed consent form\n\nExclusion Criteria:\n\n* Patients with a history of other malignancies within the past 5 years (except for cured and non-recurring cancers such as in situ carcinoma, basal cell carcinoma of the skin, etc.)\n* Patients with active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, defined by persistent signs\u002Fsymptoms related to infection, which do not improve despite appropriate antibiotics, antiviral treatments, and\u002For other therapies\n* Patients with uncontrolled systemic diseases, including unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, history of severe pericardial disease, or other cardiovascular diseases; uncontrolled hypertension (defined as systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg despite appropriate antihypertensive treatment), or a history of hypertensive crisis, hypertensive encephalopathy; uncontrolled diabetes (fasting blood glucose ≥ 10 mmol\u002FL), etc.\n* Patients known to be allergic or intolerant to the treatment drugs or excipients used in this study\n* Any clinical indicators showing contraindications to chemotherapy and surgery\n* Patients using strong inhibitors or inducers of enzymes such as CYP3A4, CYP2C8, and UGT1A1\n* Pregnant or breastfeeding women, and female patients of reproductive potential who refuse to use appropriate contraceptive measures during the study\n* Patients who participated in other clinical trials within 4 weeks before enrollment\n* Patients whom the investigator deems unsuitable for participation in the study","ALL","18 Years","75 Years",{"count":70,"type":71},51,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","The goal of this clinical trial is to evaluating the efficacy and safety of radiotherapy combined with Tislelizumab, Liposomal Irinotecan, and Capecitabine in patients with locally advanced mid-lower rectal cancer with pMMR.. Patients would be included as:1. Aged between 18-75 years, with no gender restrictions; 2. Biopsy pathology confirmed as pMMR type locally advanced mid-lower rectal adenocarcinoma (tumor lower margin ≤ 10 cm from the anal verge); 3.With the following high-risk factors: T3N+\u002FT4\u002FN2\u002FEMVI+\u002FMRF+\u002Flateral lymph node metastasis\u002Finability to preserve anal function during surgery; 4. No distant metastasis observed in routine chest and abdominal CT scans.",[77],"Rectal Cancer",[79,80,81,82,83],"Neoadjuvant therapy","rectal cancer","liposomal irinotecan","radiotherapy","immunotherapy","2026-07-23",{"date":86,"type":87},"2026-07-24","ACTUAL",{"date":89,"type":87},"2025-10-20",{"date":91,"type":71},"2027-06-30",{"name":5,"class":6},2]