[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565861":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":50,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"The Affiliated Hospital of Qingdao University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with rectal cancer receiving neoadjuvant chemotherapy and PD-1 inhibitor","EXPERIMENTAL","Experimental: Combination of drugs prior to surgery Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three to four years. The time in the study will take approximately four - six hours during pre-study, study and end of study visits.",[13],"Drug: Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles","Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three to four years. The time in the study will take approximately four - six hours during pre-study, study and end of study visits.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Yun Lu","CONTACT","18661802231","luyun@qdyy.cn",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Yuan Gao","18661806303","gaoyuan@qdyy.cn",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"The affiliated hospital of Qingdao university","RECRUITING","Qingdao","Shandong","China","CN",{"type":40,"coordinates":41},"Point",[42,43],120.38042,36.06488,{"lat":43,"lon":42},[46],{"name":47,"role":24,"phone":48,"phoneExt":20,"email":49},"Wenchang Yang","18661806480","13407196916@163.com",{"type":51,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100565861","phase-2-neoadjuvant-chemotherapy-and-pd-1-inhibitor-for-locally-advanced-rectal-cancercontrol-01-100565861",false,"NCT06647680","Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01）","Neoadjuvant Chemotherapy and Tislelizumab (PD-1 Inhibitior) for Locally Advanced Rectal Cancer: a Single-center, Prospective, Phase II Study","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent for the trial\n* Age 18 years or greater\n* Pathologically proven diagnosis of adenocarcinoma of the rectum\n* Clinically determined to be stage T3 or T4, N0-N2, and M0\n* Be fully active, able to carry on all pre-disease performance without restriction or Restricted in physically strenuous activity.\n* Contrast-enhanced imaging of the abdomen and chest by CT to exclude distant metastases and provide local tumor stage\n* Preoperative ECOG status score 0-1\n* Preoperative ASA grade I-III\n* Adequate bone marrow function\n* Adequate renal and liver function\n* No active second cancers\n* Be willing and able to comply with all aspects of the protocol\n* Women of childbearing potential must have used reliable contraception or have had a pregnancy test result within 7 days prior to enrollment. Be negative and willing to use an adequate method of contraception for the duration of the trial and for 8 weeks after the last administration of the trial drug.\n* Adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,200 cells\u002Fmm3 Platelets ≥ 100,000 cells\u002Fmm3 Hemoglobin ≥ 8.0 g\u002Fdl.\n* Adequate hepatic function within within 28 days before registration on this study:total bilirubin must be ≤ ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation \\> ULN to 1.5 x ULN due to Gilbert\\'s disease or similar syndrome involving slow conjugation of bilirubin; and AST and ALT must be ≤3 x ULN for the lab If AST and\u002For ALT is ≥ ULN but ≤ 3 x ULN, serologic testing for Hepatitis B and C must be performed and results for viral infection must be negative.\n* Adequate renal function within 28 days before randomization defined as serum creatinine ≤ 1.5 x ULN for the lab or calculated creatinine clearance \\> 30 mL\u002Fmin\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Pregnant or breastfeeding women\n* Prior invasive malignancy unless disease free for a minimum of three years\n* Preoperative body temperature ≥ 38°C or concurrent infectious diseases requiring systemic therapy;\n* Severe mental illness;\n* Severe abnormal heart, lung and kidney function\n* History of unstable angina pectoris or myocardial infarction within 6 months;\n* History of cerebral infarction or cerebral hemorrhage within 6 months;\n* Patients with abnormal coagulation function;\n* Have a history of psychotropic drug abuse or have a mental disorder;\n* Continuous use of glucocorticoids within 1 month (except topical application);\n* Patient has participated in or is participating in other clinical studies (within 6 months);\n* According to the judgment of the investigator, it endangers the patient\\'s health or affects the experimental results.","ALL","18 Years","75 Years",{"count":63,"type":64},35,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","To evaluate the safety and preliminary efficacy of preoperative chemotherapy and PD-1 inhibitor Tislelizumab for Rectal Cancer patients.Go through laboratory and medical tests to verify eligibility to enter the study, receive the experimental combination of drugs CAPOX (Oxaliplatin and Capecitabine) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three years.",[70],"Rectal Cancer Patients",[72,73,74,75,76],"Rectal cancer","Chemotherapy","Tislelizumab","Complete response","Recurrence free survival","2026-03-05",{"date":79,"type":80},"2026-03-06","ACTUAL",{"date":82,"type":80},"2025-06-01",{"date":84,"type":64},"2027-12-01",{"name":5,"class":6},1]