A Prospective Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer
The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.
• age 18-70 years old, female and male
• pathological confirmed adenocarcinoma
• clinical stage T1-3bN0, tumor maximum diameter less than 4cm
• the distance from anal verge less than 5 cm
• without distance metastases
• KPS \>=70
• with good compliance
• microsatellite repair status is MSS/pMMR
• without previous anti-cancer therapy or immunotherapy
⁃ signed the inform consent