OncoMatch/Clinical Trials/NCT06958432
Node-Sparing Short-Course Radiotherapy Sequential Chemotherapy and PD-1 Inhibitor for Mid/Low pMMR/MSS Rectal Cancer (MODIFI-RC-II)
Is NCT06958432 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Node-Sparing Radiotherapy plus Chemotherapy and PD-1 inhibitor and Conventional Radiotherapy plus Chemotherapy and PD-1 inhibitor for rectal cancer.
Treatment: Node-Sparing Radiotherapy plus Chemotherapy and PD-1 inhibitor · Conventional Radiotherapy plus Chemotherapy and PD-1 inhibitor — Most rectal cancers are microsatellite stable (MSS) or mismatch repair-proficient (pMMR) and respond poorly to PD-1 inhibitors. Radiotherapy can enhance tumor antigen release and improve responsiveness to PD-1 blockade in MSS/pMMR rectal cancer. Tumor-draining lymph nodes (TDLNs) are critical sites for anti-tumor immune activation, but radiation-induced damage and fibrosis may impair lymphatic drainage and immune responses. Previous studies have reported a remarkable pathologic complete response (pCR) rate of 77.8% using node-sparing radiotherapy in locally advanced rectal cancer. This study aims to evaluate whether node-sparing short-course radiotherapy followed by sequential chemotherapy and PD-1 blockade can improve complete response rate in the phase II part and event-free survival in phase III part, together with sphincter preservation, treatment tolerance, and prognosis in patients with mid-low pMMR/MSS rectal cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH2 proficient mismatch repair (pMMR) (positive immunohistochemical staining)
proficient mismatch repair (pMMR), defined by positive immunohistochemical staining for MSH1, MSH2, MSH6, and PMS2
Required: MSH6 proficient mismatch repair (pMMR) (positive immunohistochemical staining)
proficient mismatch repair (pMMR), defined by positive immunohistochemical staining for MSH1, MSH2, MSH6, and PMS2
Required: PMS2 proficient mismatch repair (pMMR) (positive immunohistochemical staining)
proficient mismatch repair (pMMR), defined by positive immunohistochemical staining for MSH1, MSH2, MSH6, and PMS2
Required: MLH1 proficient mismatch repair (pMMR) (positive immunohistochemical staining)
proficient mismatch repair (pMMR), defined by positive immunohistochemical staining for MSH1, MSH2, MSH6, and PMS2
Disease stage
Required: Stage T3-4N0M0, TANYN+M0
Excluded: Stage T1N0, T2N0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiotherapy
No prior systemic or local anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, immunotherapy, biologics, or small-molecule targeted therapy
Cannot have received: chemotherapy
No prior systemic or local anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, immunotherapy, biologics, or small-molecule targeted therapy
Cannot have received: immunotherapy
No prior systemic or local anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, immunotherapy, biologics, or small-molecule targeted therapy
Cannot have received: biologics
No prior systemic or local anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, immunotherapy, biologics, or small-molecule targeted therapy
Cannot have received: small-molecule targeted therapy
No prior systemic or local anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, immunotherapy, biologics, or small-molecule targeted therapy
Cannot have received: curative surgery
Prior systemic or local anti-tumor therapy for locally advanced rectal cancer, including curative surgery, chemotherapy, radiotherapy, immunotherapy (e.g., immune checkpoint inhibitors, agonists, or cell-based therapies), biologics, or small-molecule targeted therapy
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L
Kidney function
Calculated creatinine clearance (CrCl) ≥ 50 mL/min using Cockcroft-Gault formula; Urine protein < 2+ on dipstick or < 1.0 g per 24-hour collection
Liver function
Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; serum albumin ≥ 28 g/L
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%
Adequate organ function, defined as follows: Hematologic (without use of blood components or growth factors within 7 days prior to treatment initiation): Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Renal: Calculated creatinine clearance (CrCl) ≥ 50 mL/min using the Cockcroft-Gault formula; Urine protein < 2+ on dipstick or < 1.0 g per 24-hour collection; Hepatic: Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; Serum albumin ≥ 28 g/L; Coagulation: INR and APTT ≤ 1.5 × ULN; Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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