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Brief Title: A Phase III Trial of Anus-preservation in Low Rectal Adenocarcinoma Based on MMR/MSI Status
Official Title: A Randomized, Controlled, Open-label, Multicenter, Phase III Trial of Anus-preservation in Low Rectal Adenocarcinoma Based on MMR/MSI Status(APRAM)
Study ID: NCT05669092
Brief Summary: pMMR/MSS and 32 dMMR/MSI-H patientspatients were planned to be enrolled. Patients with dMMR/MSI-H will be randomly assigned to the immunotherapy arm or short-course radiotherapy sequential immunotherapy arm; pMMR/MSS patients will receive capecitabine-irinotecan based concurrent radiotherapy before being randomly assigned to the XELIRI or FOLFRINOX arm. The rate of complete response (sustained cCR for ≥ 1 year), long-term prognosis and adverse effects will be analyzed.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Zhengjiang Cancer Hospital, Hangzhou, Zhejiang, China