A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer

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.

NCT Number	NCT06312982
Lead Sponsor	Beijing Friendship Hospital Collaborators: Beijing Chao Yang Hospital, Peking University Cancer Hospital & Institute, China-Japan Friendship Hospital, Peking Union Medical College Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Fudan University, Changhai Hospital, RenJi Hospital, Sir Run Run Shaw Hospital, Shandong Provincial Hospital, Zhongnan Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Academy of Medical Sciences, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Hospital of Jilin University, First Hospital of China Medical University, Xijing Hospital of Airforce Medical University, The Second Affiliated Hospital of Air Force Military Medical University, The Affiliated Hospital of Qingdao University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Tianjin Union Medical Center, The First Affiliated Hospital of Shanxi Medical University, Sixth Affiliated Hospital, Sun Yat-sen University, The Affiliated Tumour Hospital of China Academy of Medical Science, Rocket Force Characteristic Medical Center, Tianjin Medical University General Hospital, The Second Affiliated Hospital of Naval Medical University, West China Hospital, Southern Medical University, China, First Affiliated Hospital of Chongqing Medical University, The First Affiliated Hospital of Anhui Medical University, Hebei Medical University Fourth Hospital, Sun Yat-Sen University Cancer Center, Zhejiang Tumor Hospital, Ruijin Hospital, Beijing Hospital of the Ministry of Health, Queen Mary Hospital, Hong Kong, The University of Hong Kong-Shenzhen Hospital, Taiwan Hexin Cancer Center Hospital, First Affiliated Hospital of Wenzhou Medical University
Conditions	Locally Advanced Rectal Carcinoma
Enrollment	375 participants
Start Date	2024-03-16
Primary Completion	2026-12-01 (estimated)
Study Completion	2026-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-13