OncoMatch/Clinical Trials/NCT06923345
Modified Long-Course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for MSS/pMMR High-risk Mid/Low LARC (MODIFI-RC-I)
Is NCT06923345 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Reduced CTV and Conventional CTV for rectal cancer.
Treatment: Reduced CTV · Conventional CTV — The goal of this clinical trial is to evaluate whether a total neoadjuvant therapy (TNT) regimen combining long-course chemoradiotherapy, sequential chemotherapy, and PD-1 inhibitor can improve response rates, enhance tolerability, and improve prognosis in patients with locally advanced, microsatellite-stable (MSS) rectal cancer. The main questions it aims to answer are: Does this TNT approach improve complete response (CR) rates? How does selective reduction of clinical target volume (CTV) to S2/S3 level compare with conventional CTV irradiation in terms of efficacy and safety? Researchers will compare a selective CTV reduction group and a conventional CTV irradiation group to assess differences in treatment outcomes, including complete response, tumor regression grading (TRG), organ preservation, R0 resection rates, and long-term survival. Participants will: Receive long-course chemoradiotherapy with either conventional or reduced CTV irradiation. Undergo sequential chemotherapy. Receive PD-1 inhibitor treatment. Be monitored for safety, tumor regression, and long-term survival outcomes.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH2 positive (by IHC) (positive)
Tumor biopsy immunohistochemistry indicating pMMR (MSH1, MSH2, MSH6, and PMS2 all positive)
Required: MSH6 positive (by IHC) (positive)
Tumor biopsy immunohistochemistry indicating pMMR (MSH1, MSH2, MSH6, and PMS2 all positive)
Required: PMS2 positive (by IHC) (positive)
Tumor biopsy immunohistochemistry indicating pMMR (MSH1, MSH2, MSH6, and PMS2 all positive)
Required: MSH1 positive (by IHC) (positive)
Tumor biopsy immunohistochemistry indicating pMMR (MSH1, MSH2, MSH6, and PMS2 all positive)
Disease stage
Required: Stage II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic or local anti-tumor treatment
No prior systemic or local anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, immunotherapy, biologics, or small-molecule targeted therapy.
Cannot have received: radical surgery
Prior systemic or local anti-tumor treatment for locally advanced rectal cancer, including radical surgery, chemotherapy, radiotherapy, immunotherapy (e.g., immune checkpoint inhibitors, immune cell therapy), biological agents, or targeted therapy.
Cannot have received: pelvic or abdominal radiotherapy
History of pelvic or abdominal radiotherapy.
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
Estimated creatinine clearance (CrCl) ≥ 50 mL/min; Urine protein < 2+ or 24-hour urine protein quantification < 1.0 g
Liver function
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...Renal function...Liver function...Coagulation function...Cardiac function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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