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

Phase 3 Unknown 174 enrolled Zhejiang Cancer Hospital

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2022-11-01
Primary completion: 2025-12-31
Completion: 2025-12-31

Publications

Huang CY, Bai MH, Shen JW, Sun QQ, Feng YR, Chen QP, Mao W, Ju HX, Zhu J. Anus preservation in low rectal adenocarcinoma based on MMR/MSI status (APRAM): a study protocol for a randomised, controlled, open-label, multicentre phase III trial. BMC Cancer. 2024 Jan 10;24(1):57. doi: 10.1186/s12885-024-11829-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1000 mg/m2	—
Subject	Irinotecan	Small molecule	120 mg/m2	—
Subject	Irinotecan	Small molecule	150 mg/m2	—
Subject	Irinotecan	Small molecule	200 mg/m2	—
Subject	Oxaliplatin	Small molecule	85 mg/m2	—
Subject	Toripalimab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	fluorouracil	Small molecule	2400 mg/m2	—

Indications

No indication recorded.