[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Affiliated Cancer Hospital of Shantou University Medical College\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"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":19,"type":20},51,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Rectal Cancer",[28,29,30,31,32],"Neoadjuvant therapy","rectal cancer","liposomal irinotecan","radiotherapy","immunotherapy","RECRUITING","2026-07-23",{"date":36,"type":37},"2026-07-24","ACTUAL",{"date":39,"type":37},"2025-10-20",{"date":41,"type":20},"2027-06-30",{"name":43,"class":44},"Affiliated Cancer Hospital of Shantou University Medical College","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100514887","phase-1-adjuvant-chemotherapy-in-combination-with-tislelizumab-in-lymph-node-positive-esophageal-squamous-cell-carcinoma-100514887","NCT05984342","Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Aged between 18 and 70 years\n2. Untreated before surgery (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)\n3. Histologically documented squamous cell carcinoma of the thoracic esophagus with positive lymph nodes （T1-3N1-3M0）\n4. undergoing radical esophagectomy\n5. ECOG (Eastern Cooperative Oncology Group) : 0-1\n6. No recurrent disease before adjuvant therapy\n7. Normal hemodynamic indices before the recruitment\n8. Able to understand this study and have signed informed consent\n\nExclusion Criteria:\n\n1. previous or concurrent malignancy\n2. Interstitial lung disease\n3. Requiring systemic treatment with either corticosteroids or other immunosuppressive medications\n4. Known or suspected allergy to chemotherapeutic drugs or Tislelizumab\n5. Active autoimmune disease\n6. Active hepatitis\n7. Those whom the investigator considered unsuitable for inclusion","70 Years",{"count":53,"type":20},50,[55],"PHASE1","Esophageal cancer is one of the most common malignancies in China, and esophageal squamous cell carcinoma (ESCC) is the predominant histological type. Surgical resection is still a standard therapeutic approach for patients with resectable ESCC, but the prognosis is still disappointing. Although neoadjuvant chemoradiotherapy plus surgery is currently recommended for patients with locally advanced ESCC, it is still an infrequently used procedure in China. The efficacy of adjuvant therapy on ESCC is still controversial. Recently, the CheckMate 577 trial showed that adjuvant nivolumab therapy could improve DFS for patients with residual disease after neoadjuvant chemoradiotherapy plus surgery. However, no optimal postoperative adjuvant therapy was recommended for patients with ESCC received upfront surgery. We designed a prospective randomized controlled tial to study whether immunotherapy could be used with chemotherapy after surgery to improve overall survival in these patients. The primary endpoint of the study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.",[58],"Esophageal Squamous Cell Carcinoma",[60,32,61,62,63],"esophageal squamous cell carcinoma","chemotherapy","surgery","adjuvant therapy","2023-08-02",{"date":66,"type":37},"2023-08-09",{"date":64,"type":20},{"date":69,"type":20},"2029-06-30",{"name":43,"class":44},1,""]