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.
Signed a written informed consent form and volunteered to join the study;
.Age: 18-75 years old, male or female;
Pathohistologically confirmed rectal adenocarcinoma, along with immunohistochemical results of pMMR or genetic test results of MSS;
The baseline clinical stage assessed by MRI was T1-2N1-2M0 or T3N0-2M0, MRF (-), lateral lymph nodes (-);
Previous history of allergy to monoclonal antibodies, any component of tislelizumab,and capecitabine;
History of any active autoimmune or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered after hormone replacement therapy); patients with psoriasis or asthma / allergy in childhood and adults without any intervention, but patients requiring medical intervention with bronchodilators should not be included;
A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;
Not well controlled cardiac clinical symptoms or disease, including but not limited to: such as (1) grade NYHA II above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinical meaningful supraventricular or ventricular arrhythmia without clinical intervention or clinical intervention still poor control;
Beijing Friendship Hospital
Lead sponsor
Beijing Chao Yang Hospital
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
China-Japan Friendship Hospital
Collaborator
Peking Union Medical College Hospital
Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator
Fudan University
Collaborator
Changhai Hospital
Collaborator
RenJi Hospital
Collaborator
Sir Run Run Shaw Hospital
Collaborator
Shandong Provincial Hospital
Collaborator
Zhongnan Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Sichuan Academy of Medical Sciences
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
The First Hospital of Jilin University
Collaborator
First Hospital of China Medical University
Collaborator
Xijing Hospital of Airforce Medical University
Collaborator
The Second Affiliated Hospital of Air Force Military Medical University
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Collaborator
Tianjin Union Medical Center
Collaborator
The First Affiliated Hospital of Shanxi Medical University
Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborator
The Affiliated Tumour Hospital of China Academy of Medical Science
Collaborator
Rocket Force Characteristic Medical Center
Collaborator
Tianjin Medical University General Hospital
Collaborator
The Second Affiliated Hospital of Naval Medical University
Collaborator
West China Hospital
Collaborator
Southern Medical University - Southern Hospital
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
Hebei Medical University Fourth Hospital
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Zhejiang Tumor Hospital
Collaborator
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Collaborator
Beijing Hospital of the Ministry of Health
Collaborator
Queen Mary Hospital, Hong Kong
Collaborator
The University of Hong Kong-Shenzhen Hospital
Collaborator
Taiwan Hexin Cancer Center Hospital
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator