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)
Official title: Node-Sparing Short-Course Radiotherapy Plus Sequential Chemotherapy and PD-1 Inhibitor for Mid/Low pMMR/MSS Rectal Cancer: An Open-Label, Randomized, Prospective Phase II/III Trial (MODIFI-RC-II)
Is NCT06958432 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2/3 trial studies multiple treatments including Node-Sparing Radiotherapy plus Chemotherapy and PD-1 inhibitor and Conventional Radiotherapy plus Chemotherapy for rectal cancer.
Treatment: Node-Sparing Radiotherapy plus Chemotherapy and PD-1 inhibitor · Conventional Radiotherapy plus Chemotherapy — 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
Treatments studied
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: Mismatch-repair proficient (pMMR / MSS)
Disease stage
Required: Stage T3-4N0M0, TANYN+M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: systemic or local anti-tumor therapy for rectal cancer
No prior systemic or local anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, immunotherapy, biologics, or small-molecule targeted therapy
Cannot have received: systemic or local anti-tumor therapy for locally advanced rectal cancer
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
Cannot have received: pelvic or abdominal radiotherapy
History of pelvic or abdominal radiotherapy
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; hemoglobin ≥ 90 g/L
Kidney function
CrCl ≥ 50 mL/min (Cockcroft-Gault); 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
LVEF ≥ 50%
Adequate organ function, defined as follows: Hematologic (ANC ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, hemoglobin ≥ 90 g/L); Renal (CrCl ≥ 50 mL/min, urine protein < 2+ or < 1.0 g/24h); Hepatic (total bilirubin ≤ 1.5 × ULN, AST/ALT ≤ 2.5 × ULN, albumin ≥ 28 g/L); Cardiac (LVEF ≥ 50%)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06958432 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic or local anti-tumor therapy for rectal cancer, systemic or local anti-tumor therapy for locally advanced rectal cancer, pelvic or abdominal radiotherapy disqualifies patients from enrollment.
Does this trial require MLH1?
Yes, MLH1 wild-type is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 wild-type is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage T3-4N0M0 or TANYN+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.
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