OncoMatch/Clinical Trials/NCT05563922
Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma
Is NCT05563922 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Total Neoadjuvant Chemoradiotherapy for rectal cancer.
Treatment: Total Neoadjuvant Chemoradiotherapy — This study aims to evaluate the efficacy and safety of an organ-sparing strategy after neoadjuvant chemoradiotherapy followed by transanal endoscopic microsurgery （TEM） or endoscopic local resection for early low rectal cancer（cT 1-3N0M0）.Besides, the clinical complete response rate and near-clinical complete response rate, organ preservation rate, local recurrence rate, distant metastasis rate and quality of life （QoL） will also be assessed.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Prior therapy
Cannot have received: endoscopic resection
No previous treatment (including endoscopic resection, transanal local resection, radiotherapy, chemotherapy, etc.) before enrollment
Cannot have received: transanal local resection
No previous treatment (including endoscopic resection, transanal local resection, radiotherapy, chemotherapy, etc.) before enrollment
Cannot have received: radiotherapy
No previous treatment (including endoscopic resection, transanal local resection, radiotherapy, chemotherapy, etc.) before enrollment
Cannot have received: chemotherapy
No previous treatment (including endoscopic resection, transanal local resection, radiotherapy, chemotherapy, etc.) before enrollment
Lab requirements
Blood counts
hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5*10^9 / L; platelet ≥ 100*10^9 / L
Kidney function
serum normal creatinine < 1 time upper limit; serum albumin ≥ 30g / L
Liver function
ALT and AST ≤ 2.5 times normal upper limit; ALP ≤ 2.5 times normal upper limit; serum total bilirubin < 1.5 times normal upper limit
The baseline blood routine and biochemical indexes of the subject do not meet the following criteria: hemoglobin ≥90g / L; absolute neutrophil count (ANC) ≥1.5*10^9 / L; platelet ≥100*10^9 / L; ALT and AST≤ 2.5 times normal upper limit; ALP ≤2.5 times normal upper limit; serum total bilirubin <1.5 times normal upper limit; serum normal creatinine<1 time upper limit; and serum albumin ≥30g / L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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