OncoMatch/Clinical Trials/NCT06204094
Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer
Is NCT06204094 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sintilimab and Capecitabine for locally advanced rectal cancer.
Treatment: Sintilimab · Capecitabine · Oxaliplatin — phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH2 positive (proficient MMR) (positive)
tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive
Required: MSH6 positive (proficient MMR) (positive)
tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive
Required: PMS2 positive (proficient MMR) (positive)
tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive
Required: MSH1 positive (proficient MMR) (positive)
tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive
Disease stage
Required: Stage CT2N+M0, CT3-4AN0/+M0 (clinical (cTNM))
the clinical stage is cT2N+M0/cT3-4aN0/+M0, the lymph nodes are limited to the mesorectum, the circumferential resection margin is negative
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-tumor therapy
No previous treatment (including anti-tumor therapy、immunotherapy or pelvic radiation)
Cannot have received: immunotherapy
No previous treatment (including anti-tumor therapy、immunotherapy or pelvic radiation)
Cannot have received: pelvic radiation
No previous treatment (including anti-tumor therapy、immunotherapy or pelvic radiation)
Lab requirements
Blood counts
white blood cells ≥3500/mm3, neutrophils ≥1800/mm3, platelets ≥100,000/mm3, hemoglobin ≥100 g/L; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN
Kidney function
creatinine clearance ≥50 mL/mi, creatinine ≤1.5 × ULN
Liver function
aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.25 × ULN, serum albumin ≥28 g/L
Cardiac function
Adequate hematologic, hepatic, renal, thyroid and cardiac function: white blood cells ≥3500/mm3, neutrophils ≥1800/mm3, platelets ≥100,000/mm3, hemoglobin ≥100 g/L; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.25 × ULN, serum albumin ≥28 g/L. creatinine clearance ≥50 mL/mi, creatinine ≤1.5 × ULN;
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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