Clinical Trial

Neoadjuvant Chemoradiotherapy Followed by Chemotherapy With or Without Tislelizumab for Resectable Ultra-low Rectal Cancer: The RELIEVE-02 Study

Not Yet Recruiting Phase 3
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Summary
This open-label, multicenter, randomized controlled trial involved 154 patients with pathologically confirmed, previously untreated, resectable MSI-L or MSS/pMMR ultra-low rectal adenocarcinoma. Patients were randomly assigned (1:1) to two groups to receive concurrent chemoradiotherapy followed by 4-6 cycles of chemotherapy ± tislelizumab. After treatment, patients who achieved complete clinical response (cCR), including those who reached pCR after local excision, or near cCR with pCR after local excision, were recommended to continue with 4-2 cycles of chemotherapy ± tislelizumab, followed by a watch-and-wait approach. Patients evaluated as incomplete responders were recommended for total mesorectal excision (TME) surgery. The primary endpoint is the anus preservation rate, while secondary endpoints include CR rate, 1-year/2-year/3-year organ preservation rates, 1-year/2-year/3-year EFS rates, and 1-year/2-year/3-year OS rates, etc.
Trial Details
NCT Number NCT07132463
Lead Sponsor Fudan University
Conditions Rectal Cancer
Enrollment 154 participants
Start Date 2025-08
Primary Completion 2027-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2025-08-20