OncoMatch/Clinical Trials/NCT06417476
Short-course Radiotherapy or Long-course Chemoradiation Followed by MFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer
Is NCT06417476 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for rectal neoplasms.
Treatment: Irinotecan · Oxaliplatin · Calcium Formate · Fluorouracil · Capecitabine — Given the growing focus on preserving organ function and the utilization of neoadjuvant therapy, it is important to investigate and enhance the application of comprehensive neoadjuvant therapy in low rectal cancer. This approach aims to minimize or circumvent the organ dysfunction and subsequent decline in quality of life associated with radical surgery, with improving disease-free survival (DFS), while . Consequently, we propose to initiate a multicenter clinical trial to examine the medium- and long-term effectiveness of complete neoadjuvant therapy (comprising either short-course radiotherapy or long-course chemoradiation, followed by consolidation chemotherapy with mFOLFOXIRI) in increasing organ preservation rates in patients with low rectal cancer.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: MSH1 proficient mismatch repair (pMMR) by IHC (positive expression)
Positive expression of pMMR (MSH1/MSH2/MSH6/PMS2) on tumor biopsy immunohistochemistry
Required: MSH2 proficient mismatch repair (pMMR) by IHC (positive expression)
Positive expression of pMMR (MSH1/MSH2/MSH6/PMS2) on tumor biopsy immunohistochemistry
Required: MSH6 proficient mismatch repair (pMMR) by IHC (positive expression)
Positive expression of pMMR (MSH1/MSH2/MSH6/PMS2) on tumor biopsy immunohistochemistry
Required: PMS2 proficient mismatch repair (pMMR) by IHC (positive expression)
Positive expression of pMMR (MSH1/MSH2/MSH6/PMS2) on tumor biopsy immunohistochemistry
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: surgery
No prior surgery for rectal cancer
Cannot have received: chemotherapy
No prior chemotherapy for rectal cancer
Cannot have received: radiotherapy
No prior radiotherapy for rectal cancer
Cannot have received: biological therapy
No prior biological therapy
Cannot have received: pelvic or abdominal radiotherapy
History of pelvic or abdominal radiotherapy
Lab requirements
Blood counts
WBC >4000/mm^3, PLT >100,000/mm^3, Hb >10g/dL (chronic anemia with Hb < 10.0g/dL subject to multidisciplinary team review)
Kidney function
Serum creatinine ≤1.5×ULN or creatinine clearance >50 mL/min
Liver function
Serum total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert syndrome); AST and ALT ≤2.5×ULN
Cardiac function
No arrhythmia requiring antiarrhythmic therapy (excluding beta-blockers or digoxin), no symptomatic coronary artery disease or recent myocardial ischemia (within 6 months), or congestive heart failure above NYHA Grade II
Blood Counts: WBC >4000/mm^3, PLT >100,000/mm^3, Hb >10g/dL (chronic anemia with Hb < 10.0g/dL subject to multidisciplinary team review). Liver Function: Serum total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert syndrome); AST and ALT ≤2.5×ULN. Renal Function: Serum creatinine ≤1.5×ULN or creatinine clearance >50 mL/min. Cardiac Conditions: Arrhythmia requiring antiarrhythmic therapy (excluding beta-blockers or digoxin), symptomatic coronary artery disease or recent myocardial ischemia (within 6 months), or congestive heart failure above NYHA Grade II.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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