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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Targeted therapy

CetuximabBevacizumab

Other

PD-1 monoclonal antibodymFOLFOX6 regimen

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06908031 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require MMR?

Yes, MMR proficient is a required biomarker for enrollment.

Does this trial require MSH2?

Yes, MSH2 microsatellite stable is a required biomarker for enrollment.

What disease stage is eligible?

Stage CT3NX 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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