Overview

Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study

Status:
NOT_YET_RECRUITING

Trial end date:
2028-12-01

Target enrollment:

Participant gender:

Summary

This is an open-label, multi-center, single-arm clinical study. All patients received concurrent chemoradiation therapy (CRT) followed by 4 cycles of tislelizumab combined with CAPOX, then underwent clinical response assessment. Patients who achieved CR (cCR+ pCR confirmed by local resection of ncCR) continue tislelizumab combined with CAPOX for another 4 cycles and tislelizumab for 9 cycles, then Watch and Wait. Patients who did not achieved CR underwent total mesorectal excision (TME).

Phase:

PHASE2

Details

Lead Sponsor:

Fudan University

Collaborators:

First Hospital of China Medical University
Hebei Medical University Fourth Hospital
Huadong Hospital
Liaoning Cancer Hospital & Institute
RenJi Hospital
Shanghai Changzheng Hospital
Shanghai Zhongshan Hospital

Treatments:

Capecitabine
Oxaliplatin
Radiotherapy
tislelizumab