nctId: NCT06262581 id: 2021-FXY-471 briefTitle: Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery overallStatus: RECRUITING date: 2023-09-23 date: 2024-11-30 date: 2025-12-31 date: 2024-02-16 date: 2024-02-16 name: Sun Yat-sen University class: OTHER 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. conditions: DMMR Colorectal Cancer conditions: Anti PD-1 conditions: Immunotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Tisleizumab(BGB-A317) measure: pathological complete regression rate measure: CR rate measure: Major Pathological Response rate measure: Disease free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Gong C Chen, Prof role: CONTACT phone: +862087343584 email: chengong@sysucc.org.cn name: Zhi-zhong Pan, Prof role: SUB_INVESTIGATOR name: Xiao-jun Wu, Prof role: SUB_INVESTIGATOR name: Zhen-hai Lu, Prof role: SUB_INVESTIGATOR name: Pei-rong Ding, Prof role: SUB_INVESTIGATOR name: Li-ren Li, Prof role: SUB_INVESTIGATOR name: Fu-long Wang, M.D. role: SUB_INVESTIGATOR name: Rong-xin Zhang, M.D. role: SUB_INVESTIGATOR name: Jian-hong Peng, M.D. role: SUB_INVESTIGATOR name: Jun-zhong Lin, M.D. role: SUB_INVESTIGATOR name: Ling-heng Kong, M.D. role: SUB_INVESTIGATOR name: Cong Li, M.D. role: SUB_INVESTIGATOR name: Wu Jiang, M.D. role: SUB_INVESTIGATOR name: Wen-hua Fan, M.D. role: SUB_INVESTIGATOR name: Wen-hao Zhou, M.D. role: SUB_INVESTIGATOR name: Jing-hua Tang, M.D. role: SUB_INVESTIGATOR name: Yuan Li, M.D. role: SUB_INVESTIGATOR name: Miaoqing Wu role: SUB_INVESTIGATOR name: Di Cao role: SUB_INVESTIGATOR name: Yi-fan Liu role: SUB_INVESTIGATOR name: Da Kang role: SUB_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False