The study is being conducted to evaluate the safety and efficacy of Adebrelimab and SHR-8068 in combination with chemoradiotherapy in subjects with rectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
165
Adebrelimab in combination with SHR-8068 and chemotherapy.
Adebrelimab combined with chemotherapy.
Chemotherapy.
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGPhase II: pCR (Pathological Complete Response) rate
Evaluated by investigators.
Time frame: 12 months
Phase II: Clinical complete response (cCR) rate
Evaluated by investigators per RECIST v1.1.
Time frame: 60 months
Phase II: Disease-free survival (DFS)
Evaluated by investigators per RECIST v1.1.
Time frame: 60 months
Phase II: EFS (Event Free Survival)
Evaluated by investigators per RECIST v1.1.
Time frame: 60 months
Phase II: Tumor regression grade (TRG)
Evaluated by investigators per RECIST v1.1.
Time frame: 60 months
Phase II: R0 resection rate
Evaluated by investigators per RECIST v1.1.
Time frame: 60 months
Phase II: length of hospital stay
Evaluated by investigators per RECIST v1.1.
Time frame: 60 months
Phase II: Overall survival (OS)
Evaluated by investigators per RECIST v1.1.
Time frame: 60 months
Phase II: Perioperative mortality (within 30 days and 90 days after surgery)
Evaluated by investigators per RECIST v1.1.
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Time frame: 60 months