protocolSection identificationModule nctId: NCT06312982, orgStudyIdInfo id: BFH-niCRT-04, briefTitle: A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer: From a Multicenter Phase II Cohort to a Phase III Randomized Controlled Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, collaborators name: Beijing Chao Yang Hospital, collaborators name: Peking University Cancer Hospital & Institute, collaborators name: CHINA-JAPEN FRIENDSHIP HOSPITAL, collaborators name: Peking Union Medical College Hospital, collaborators name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, collaborators name: Fudan University, collaborators name: Changhai Hospital, collaborators name: RenJi Hospital, collaborators name: Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine, collaborators name: Shandong Provincial Hospital, collaborators name: Zhongnan Hospital of Wuhan University & Second Clinical Hospital of Wuhan University, collaborators name: The First Affiliated Hospital of Zhengzhou University, collaborators name: West China School of Medicine and West China Hospital, Sichuan University, collaborators name: Sichuan Academy of Medical Sciences, collaborators name: The Sixth Affiliated Hospital, Sun Yat-sen University, collaborators name: The First Hospital of Jilin University, collaborators name: First Hospital of China Medical University, collaborators name: Army Medical Center of PLA, collaborators name: The First Affiliated Hospital of Anhui Medical University, descriptionModule briefSummary: The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer.The main questions it aims to answer are:To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer To assess rectal or anal retention as well as quality of life. Participants will receive a long course of NCRT (50 Gy / 25f, capecitabine 850-1000 mg / m2, BID, PO, D1-D5, QW) within the first 5 weeks. In regard to tumor immunotherapy, enrolled patients will receive tislelizumab (200 mg, iv) on the first day at week 2,5, and 8 after initiation of radiotherapy. Thereafter, patients will be treated with two 14-day cycles of the CAPOX（Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt; D1-D14, capecitabine, 850-1000mg / m2, BID, PO）regimen. Two CAOPX regimens were treated one week apart., conditionsModule conditions: Locally Advanced Rectal Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 375, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab, outcomesModule primaryOutcomes measure: CR, secondaryOutcomes measure: AE rate, secondaryOutcomes measure: NAR score, secondaryOutcomes measure: ORR, secondaryOutcomes measure: OPR, secondaryOutcomes measure: immune-related adverse event rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, Capital Medical University, status: RECRUITING, city: Beijing, state: Beijing, zip: 100050, country: China, contacts name: Yao Hongwei, M.D, role: CONTACT, phone: 86 13611015609, email: yaohongwei@ccmu.edu.cn, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Friendship Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100050, country: China, contacts name: Zhongtao Zhang,, MD, role: CONTACT, phone: +86-13801060364, email: zhangzht@ccmu.edu.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False