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OncoMatch/Clinical Trials/NCT05984485

The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer

Is NCT05984485 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies non-drug interventions for rectal cancer.

Phase 3RecruitingSun Yat-sen UniversityNCT05984485Data as of May 2026

Comparative analysis of the clinical efficacy between primary Total Mesorectal Excision (TME) surgery and neoadjuvant chemotherapy combined with TME surgery for low-risk locally advanced rectal cancer. Randomly enrolling eligible patients into either the control group receiving neoadjuvant chemotherapy combined with TME surgery or the experimental group receiving primary TME surgery, and subsequently comparing the clinical outcomes of the two groups

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Required: Stage T1-3BN1-2, T3AN0, T3BN0 (MRI-based)

High-resolution MRI indicates low-risk locally advanced rectal cancer: T1-3bN1-2 or T3aN0 or T3bN0; no involvement of the anal sphincter; negative mesorectal fascia (MRF) status; negative extramural vascular invasion (EMVI); no cancer nodules

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Lab requirements

Kidney function

adequate renal function required; severe kidney dysfunction excluded

Liver function

adequate hepatic function required; severe liver dysfunction excluded

Cardiac function

adequate cardiac function required; significant cardiopulmonary impairment excluded

Adequate physical condition to tolerate surgery and neoadjuvant chemotherapy, including cardiac, pulmonary, hepatic, and renal functions; severe liver or kidney dysfunction, significant cardiopulmonary impairment [excluded]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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