OncoMatch/Clinical Trials/NCT07279077
Node-Sparing Low-Dose Radiotherapy Concurrent With Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advanced Colon Cancer: A Prospective, Single-Arm, Phase II Trial
Is NCT07279077 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Node-Sparing Low-Dose Radiotherapy Concurrent With Chemotherapy and PD-1 Inhibitor for colon cancer.
Treatment: Node-Sparing Low-Dose Radiotherapy Concurrent With Chemotherapy and PD-1 Inhibitor — Most colorectal cancers belong to the microsatellite stable (MSS) or proficient mismatch repair (pMMR) subtypes, with limited response to PD-1 inhibitors. Radiotherapy can increase the release of tumor-associated antigens, thereby improve responsiveness to PD-1 blockade in MSS/pMMR rectal cancer. Tumor-draining lymph nodes are important sites for PD-1 inhibitors to exert antitumor effects, and studies have reported that direct radiation-induced damage and fibrosis can inhibit lymph node drainage and anti-tumor function. Accumulating evidence indicates that low-dose radiotherapy reprograms the tumor microenvironment (TME), transforming immunosuppressive 'cold' tumors into immunostimulatory 'hot' tumors. This transition is mediated by modulating the gut microbiota, eliciting innate and adaptive immune responses, inhibiting immunosuppressive cells, and promoting the infiltration of T and B lymphocytes.Therefore, this study aims to evaluate whether node-sparing low-dose radiotherapy (1Gy/8f) concurrent with chemotherapy and PD-1 inhibitor can improve the pathological complete response (pCR) rate, enhance tolerability, and improve prognosis in patients with pMMR/MSS high-risk locally advanced colon cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH2 positive expression (positive)
pMMR (proficient Mismatch Repair), defined as positive expression of all four proteins: MSH1, MSH2, MSH6, and PMS2
Required: MSH6 positive expression (positive)
pMMR (proficient Mismatch Repair), defined as positive expression of all four proteins: MSH1, MSH2, MSH6, and PMS2
Required: PMS2 positive expression (positive)
pMMR (proficient Mismatch Repair), defined as positive expression of all four proteins: MSH1, MSH2, MSH6, and PMS2
Required: MLH1 positive expression (positive)
pMMR (proficient Mismatch Repair), defined as positive expression of all four proteins: MSH1, MSH2, MSH6, and PMS2
Disease stage
Required: Stage IIB, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic or local anti-tumor therapy
No prior systemic or local anti-tumor therapy for colon cancer before study treatment, including radiotherapy, chemotherapy, immunotherapy, biologics, small molecule targeted therapy, etc.
Cannot have received: radical surgery
Prior receipt of any systemic or local anti-tumor therapy for locally advanced colon cancer, including radical surgery, chemotherapy, radiotherapy, immunotherapy (including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any therapy targeting tumor immune mechanisms), biologics, small molecule targeted therapy, etc.
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L (1,500/mm³); Platelet count ≥ 100 × 10⁹/L (100,000/mm³); Hemoglobin ≥ 90 g/L
Kidney function
Calculated Creatinine Clearance (CrCl) ≥ 50 mL/min; Urine protein < 2+ or 24-hour urine protein quantification < 1.0 g
Liver function
Serum Total Bilirubin (TBil) ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; Serum Albumin (ALB) ≥ 28 g/L
Cardiac function
Left Ventricular Ejection Fraction (LVEF) ≥ 50%
Adequate organ function: Hematology (no use of blood components or cell growth factors within 7 days prior to the start of study treatment): i. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L (1,500/mm³). ii. Platelet count ≥ 100 × 10⁹/L (100,000/mm³). iii. Hemoglobin ≥ 90 g/L. Renal: i. Calculated Creatinine Clearance (CrCl) ≥ 50 mL/min (calculated using the Cockcroft-Gault formula: CrCl (mL/min) = {(140 - Age) × Weight (kg) × 0.85 [if female]} / (Serum Creatinine (mg/dL) × 72)). ii. Urine protein < 2+ or 24-hour urine protein quantification < 1.0 g. Hepatic: i. Serum Total Bilirubin (TBil) ≤ 1.5 × ULN (Upper Limit of Normal). ii. AST and ALT ≤ 2.5 × ULN. iii. Serum Albumin (ALB) ≥ 28 g/L. Coagulation: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN. Cardiac Function: i. Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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