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A Phase III Trial of Anus-preservation in Low Rectal Adenocarcinoma Based on MMR/MSI Status

Radiation Clinical Trial

Official title:
A Randomized, Controlled, Open-label, Multicenter, Phase III Trial of Anus-preservation in Low Rectal Adenocarcinoma Based on MMR/MSI Status(APRAM)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05669092
Study type Interventional
Source Zhejiang Cancer Hospital
Contact JI ZHU
Phone 13501978674
Email zhuji@zjcc.org.cn
Status Recruiting
Phase Phase 3
Start date November 1, 2022
Completion date December 31, 2025
View Details
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