This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with AK104 and chemotherapy + TME surgery in patients with advanced rectal cancer.
1. Age 18-75 years old, gender is not limited;
2. Stage II/III under MRI or endoscopic ultrasound ;
3. Fiber colonoscopy or diagnosis examination, the lower boundary of the lesion is 15m ≤ from the margin;
4. Rectal adenocarcinoma confirmed or revisited by pathology;
1. Previous anti-PD-1/L1 and anti-CTLA-4 immune drugs or other immunoassay drugs;
2. With severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.;
3. Symptomatic interstitial lung disease or active infection/non-infectious pneumonia;
4. Patients have risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer or other known risk factors for intestinal perforation;
JIN JING
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution