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OncoMatch/Clinical Trials/NCT06908031

SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy for HIgh-Risk pMMR/MSS Rectal Cancer

Is NCT06908031 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including PD-1 monoclonal antibody and mFOLFOX6 regimen for rectal adenocarcinoma.

Phase 2RecruitingSixth Affiliated Hospital, Sun Yat-sen UniversityNCT06908031Data as of May 2026

Treatment: PD-1 monoclonal antibody · mFOLFOX6 regimen · Cetuximab · BevacizumabTo explore the efficacy and safety of short-course radiotherapy combined with mFOLFOX6, PD-1 monoclonal antibody and cetuximab (for RAS/BRAF Wild-Type)/bevacizumab (for RAS/BRAF Mutant) in High-Risk pMMR/MSS Rectal Adenocarcinoma through a prospective study, providing high-level evidence-based medical evidence for the use in the treatment of high-risk rectal cancer.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: MMR proficient

pMMR

Required: MSH2 microsatellite stable

MSS

Disease stage

Required: Stage CT3NX

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: radiotherapy

No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).

Cannot have received: chemotherapy

No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).

Cannot have received: targeted therapy

No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).

Cannot have received: immunotherapy

No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).

Cannot have received: anti-PD-1 therapy

history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy

Cannot have received: anti-PD-L1 therapy

history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy

Cannot have received: anti-PD-L2 therapy

history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy

Cannot have received: anti-CTLA-4 therapy

history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy

Lab requirements

Blood counts

white blood cells (wbc) ≥3.0×10^9/l or absolute neutrophil count (anc) ≥1.5×10^9/l; hemoglobin (hgb) ≥80 g/l; platelets (plt) ≥100×10^9/l

Kidney function

creatinine (creat) <1.5 times the upper limit of the normal range

Liver function

liver transaminases (ast/alt) <3.0 times the upper limit of the normal range; total bilirubin (tbil) <1.5 times the upper limit of the normal range

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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