protocolSection identificationModule nctId: NCT06262581, orgStudyIdInfo id: 2021-FXY-471, briefTitle: Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-23, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: According to the cancer statistics in 2020, colorectal cancer (CRC) remains a major public health issue worldwide, representing the third common cancer (10%) and second leading cause of death (9.4%) with 5-year survival rate approaching 65%. Meanwhile, 28.8% of the newly diagnosed cases and 30.3% of the CRC-related death occurs in China. Among all the CRC, stage I-III account for 75%. For the standard management for non-late stage(stage I-III) CRC patients, surgery including the primary site and local lymph nodes dissection has been the most important one. But for the high-risk stage II and locally-advanced stage III CRC, neoadjuvant or adjuvant therapy such as chemotherapy and radiotherapy plays a vital role in preventing the residual cancer cells to relapse and spread to distant sites after surgery. For the past decades, immunotherapy like anti-PD-1 and anti-CTLA4 checkpoint inhibitor achieves great process in solid tumor treatment especially for late-stage CRC. And Pembrolizumab and Nivolumab has been proved for dMMR/MSI-H late-stage-CRC by FDA. Combination of Ipilimumab and Nivolumab has achieved great success among the early-stage-CRC in NICHE study. The investigators here to carry out a phase II clinical trial to explore the safety and effect of single anti-PD-1 (Tisleizumab-BGB-A317 ) neoadjuvant treatment for non-late stage CRC patients., conditionsModule conditions: DMMR Colorectal Cancer, conditions: Anti PD-1, conditions: Immunotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Tisleizumab(BGB-A317), outcomesModule primaryOutcomes measure: pathological complete regression rate, secondaryOutcomes measure: CR rate, secondaryOutcomes measure: Major Pathological Response rate, secondaryOutcomes measure: Disease free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-Sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Gong C Chen, Prof, role: CONTACT, phone: +862087343584, email: chengong@sysucc.org.cn, contacts name: Zhi-zhong Pan, Prof, role: SUB_INVESTIGATOR, contacts name: Xiao-jun Wu, Prof, role: SUB_INVESTIGATOR, contacts name: Zhen-hai Lu, Prof, role: SUB_INVESTIGATOR, contacts name: Pei-rong Ding, Prof, role: SUB_INVESTIGATOR, contacts name: Li-ren Li, Prof, role: SUB_INVESTIGATOR, contacts name: Fu-long Wang, M.D., role: SUB_INVESTIGATOR, contacts name: Rong-xin Zhang, M.D., role: SUB_INVESTIGATOR, contacts name: Jian-hong Peng, M.D., role: SUB_INVESTIGATOR, contacts name: Jun-zhong Lin, M.D., role: SUB_INVESTIGATOR, contacts name: Ling-heng Kong, M.D., role: SUB_INVESTIGATOR, contacts name: Cong Li, M.D., role: SUB_INVESTIGATOR, contacts name: Wu Jiang, M.D., role: SUB_INVESTIGATOR, contacts name: Wen-hua Fan, M.D., role: SUB_INVESTIGATOR, contacts name: Wen-hao Zhou, M.D., role: SUB_INVESTIGATOR, contacts name: Jing-hua Tang, M.D., role: SUB_INVESTIGATOR, contacts name: Yuan Li, M.D., role: SUB_INVESTIGATOR, contacts name: Miaoqing Wu, role: SUB_INVESTIGATOR, contacts name: Di Cao, role: SUB_INVESTIGATOR, contacts name: Yi-fan Liu, role: SUB_INVESTIGATOR, contacts name: Da Kang, role: SUB_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False