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.
Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
Male or female ≥ 18 years old and ≤75 years old.
ECOG performance status of 0-1.
An assessment of resectable locally advanced rectal.
Patients with rectal cancer who have experienced local recurrence after previous treatment.
Patients with concurrent colon tumors.
Patients with initially unresectable colorectal cancer as evaluated by researchers or those whose condition is determined by researchers to be intolerant to surgery.
Clinical or imaging examinations suggest the presence of intestinal obstruction or perforation, or those assessed by researchers as having a relatively high risk of perforation or bleeding.
Parallel
Adebrelimab in combination with SHR-8068 and chemotherapy
DrugAdebrelimab in combination with SHR-8068 and chemotherapy.
Adebrelimab combined with chemotherapy
DrugAdebrelimab combined with chemotherapy.
Chemotherapy
DrugChemotherapy.
Phase II: pCR (Pathological Complete Response) rate
Evaluated by investigators.
Phase II: Clinical complete response (cCR) rate
Evaluated by investigators per RECIST v1.1.
Phase II: Disease-free survival (DFS)
Evaluated by investigators per RECIST v1.1.
Phase II: EFS (Event Free Survival)
Evaluated by investigators per RECIST v1.1.
Phase II: Tumor regression grade (TRG)
Evaluated by investigators per RECIST v1.1.
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