A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer
Status:
RECRUITING
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
PHASE2
Details
Lead Sponsor:
Beijing Friendship Hospital
Collaborators:
Beijing Chao Yang Hospital Beijing Hospital of the Ministry of Health Cancer Institute and Hospital, Chinese Academy of Medical Sciences Changhai Hospital China-Japan Friendship Hospital Daping Hospital, the Third Military Medical University First Affiliated Hospital of Chongqing Medical University First Affiliated Hospital of Wenzhou Medical University First Hospital of China Medical University Fudan University Hebei Medical University Fourth Hospital Peking Union Medical College Hospital Peking University Cancer Hospital & Institute Queen Mary Hospital, Hong Kong RenJi Hospital Rocket Force Characteristic Medical Center Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shandong Provincial Hospital Sichuan Academy of Medical Sciences Sir Run Run Shaw Hospital Sixth Affiliated Hospital, Sun Yat-sen University Southern Medical University - Southern Hospital Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Sun Yat-sen University Taiwan Hexin Cancer Center Hospital Tangdu Hospital-Air Force Medical University The Affiliated Hospital of Qingdao University The Affiliated Tumour Hospital of China Academy of Medical Science The First Affiliated Hospital of Anhui Medical University The First Affiliated Hospital of Shanxi Medical University The First Affiliated Hospital of Zhengzhou University The First Hospital of Jilin University The Second Affiliated Hospital of Naval Medical University The University of Hong Kong-Shenzhen Hospital Tianjin Medical University General Hospital Tianjin Union Medical Center West China Hospital Xijing Hospital of Airforce Medical University Zhejiang Tumor Hospital Zhongnan Hospital