Overview

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

Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Zhejiang Cancer Hospital
Treatments:
Capecitabine
Immune Checkpoint Inhibitors
Irinotecan
Oxaliplatin