SCRT vs LCRT iTNT Phase 3 Rectal Cancer Trial, 612 Patients
Summary
NCT07551479 is a prospective, multicentre, randomized Phase III trial enrolling 612 patients with microsatellite stable (MSS) locally advanced rectal cancer (LARC, T3-4/N+M0) harboring at least one high-risk feature. Patients are randomized 1:1 to total neoadjuvant therapy (TNT) using long-course chemoradiotherapy (50Gy/25Fx with capecitabine) followed by 6 cycles of CAPOX, versus intensified TNT (iTNT) using short-course radiotherapy (25Gy/5Fx) followed by 6 cycles of Serplulimab combined with CAPOX. The primary endpoint is 3-year event-free survival rate, with secondary endpoints including complete response rate, organ preservation, disease-free survival, and adverse event rates.
“In this prospective, multicentre, randomized phase III trial, 612 locally advanced rectal cancer (LARC, T3-4/N+M0) patients with at least one high-risk features (lower location (≤5cm), cT4, cN2, MRF+, EMVI+, TD+) will be included, and randomly assigned to TNT group and iTNT group (1:1).”
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What changed
NCT07551479 records a Phase III clinical trial comparing two total neoadjuvant therapy paradigms for locally advanced rectal cancer: standard TNT using long-course chemoradiotherapy with oral capecitabine followed by CAPOX chemotherapy, versus intensified TNT using short-course radiotherapy followed by the same CAPOX regimen augmented with Serplulimab, a PD-1 inhibitor. The 612-patient study targets individuals with MSS tumors and at least one high-risk feature (lower location ≤5cm, cT4, cN2, MRF+, EMVI+, or TD+), randomised equally between arms. Patients achieving clinical complete response after neoadjuvant therapy will be managed under a watch-and-wait protocol; non-responding patients will proceed to surgery.
Clinical investigators and oncology research sites conducting trials in rectal cancer should be aware that this study introduces an immunotherapy-augmented short-course neoadjuvant arm as a direct comparator to the established long-course chemoradiotherapy standard. The inclusion of a PD-1 inhibitor (Serplulimab) in the experimental arm may necessitate companion biomarker testing for MSS status, which is itself an eligibility criterion. Sponsors of competing rectal cancer TNT programmes should monitor this trial's design as it may influence future protocol expectations for organ-preservation endpoints.
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Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
SCRT Based iTNT vs. LCRT Based TNT for MSS Locally Advanced Rectal Cancer
Phase 3 NCT07551479 Kind: PHASE3 Apr 24, 2026
Abstract
In this prospective, multicentre, randomized phase III trial, 612 locally advanced rectal cancer (LARC, T3-4/N+M0) patients with at least one high-risk features (lower location (≤5cm), cT4, cN2, MRF+, EMVI+, TD+) will be included, and randomly assigned to TNT group and iTNT group (1:1). TNT group receives long-course chemoradiotherapy (50Gy/25Fx concurrent with oral capecitabine) followed by 6 cycles of CAPOX. iTNT group receives short-course radiotherapy (25Gy/5Fx) followed by 6 cycles of Serplulimab combined with CAPOX. After the efficacy evaluation, the patients who achieves clinical complete response (cCR) will be managed by a watch and wait (W&W) protocol and non-cCR patients will be recommended surgery. The primary endpoint is 3-year event-free survival rate (3yEFS%). The secondary endpoints include the complete response (CR, pathological complete response [pCR] plus cCR) rate, 3-year organ preservation rate, 3-year disease-free survival rate (3yDFS%), 3-year local recurrence free survival rate (3yLRFS%), 3-year distant metastasis free survival rate (3yDMFS%), 3-year overall survival rate (3yOS%), grade 3-4 acute adverse effects (AE) rate, rate of surgical complications, anal functions and quality of life, etc.
Conditions: Locally Advanced Rectal Cancer (LARC), MSS (Microsatellite Stable)
Interventions: short-course radiaotherapy, long-course chemoradiaothearpy, Capecitabine, Oxaliplatin, PD-1 inhibitor
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