This is a phase II/III, multi-center, open-label, 3-arm, randomized controlled trial assessing the efficacy and safety of neoadjuvant long-course chemoradiation combined with Tislelizumab (PD-1 inhibitor) and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+concurrent PD-1 inhibitor; Experiment group 2: chemoradiation+sequential PD-1 inhibitor) with a control group (chemoradiation only).
aged 18~75
ECOG score 0~2
biopsy diagnosed rectal adenocarcinoma, distal margin within 10cm to anal verge
no distant metastasis, staged II/III (T4b excluded) by MRI
multiple cancers, or with concomitant malignant tumors besides rectal cancer
having received any anti-cancer treatment (surgery, drugs, etc.) in the past 5 years
history of recent major surgery
with condition that affects the absorption of capecitabine via gastrointestinal tract (e.g. inability to swallow, nausea, vomiting, chronic diarrhea, etc.)
Parallel
Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)
Combination productTislelizumab is added to long-course chemoradiation (CRT) of LARC patients, with CRT+concurrent Tislelizumab for Arm 1, CRT+sequential Tislelizumab for Arm 2, and CRT only for Arm 3
pCR rate
pathological complete response rate
NAR score
neoadjuvant rectal score
2-y OS rate
2-year overall survival rate
2-y DFS rate
2-year disease free survival rate
3-y OS rate
3-year overall survival rate
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Beijing Friendship Hospital
Lead sponsor
Beijing Chao Yang Hospital
Collaborator
Xuanwu Hospital, Beijing
Collaborator
Beijing Hospital
Collaborator
Peking Union Medical College Hospital
Collaborator
Peking University First Hospital
Collaborator
Peking University People's Hospital
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
BeiGene
Collaborator
