OncoMatch/Clinical Trials/NCT05563922
Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma
Is NCT05563922 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Colorectal Cancer
Demographics
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.
Frequently asked questions
Is NCT05563922 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages