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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
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)
Demographics
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.
Frequently asked questions
Is NCT06204094 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.
Does this trial require MSH2?
Yes, MSH2 positive (proficient MMR) is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 positive (proficient MMR) is a required biomarker for enrollment.
Does this trial require PMS2?
Yes, PMS2 positive (proficient MMR) is a required biomarker for enrollment.
What disease stage is eligible?
Stage CT2N+M0 or CT3-4AN0/+M0 is required.
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 qualify