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OncoMatch/Clinical Trials/NCT06794086

SBRT + PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases

Is NCT06794086 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including PD-1 Monoclonal Antibody and Chemotherapy for colorectal cancer.

Phase 3RecruitingJun HuangNCT06794086Data as of May 2026

Treatment: PD-1 Monoclonal Antibody · ChemotherapyTo explore the efficacy and safety of stereotactic body radiation therapy (SBRT) combined with PD-1 monoclonal antibody in the treatment of unresectable colorectal cancer liver metastasis through a prospective study, providing high-level evidence-based medical evidence for the use of SBRT combined with PD-1 inhibitors in the treatment of unresectable colorectal cancer liver metastasis.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: MLH1 proficient MMR

Patients with pMMR/MSS colorectal adenocarcinoma

Required: MSH2 proficient MMR

Patients with pMMR/MSS colorectal adenocarcinoma

Required: MSH6 proficient MMR

Patients with pMMR/MSS colorectal adenocarcinoma

Required: PMS2 proficient MMR

Patients with pMMR/MSS colorectal adenocarcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: radiotherapy

Exception: no prior radiotherapy for liver metastases, or liver tissue near planned irradiation site not previously irradiated

Patients who have not previously received radiotherapy for liver metastases, or whose liver tissue near the planned irradiation site has not been previously irradiated

Cannot have received: anti-PD-1 therapy

History of prior treatment with anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapies

Lab requirements

Blood counts

peripheral blood counts within allowable ranges (tested within 15 days before the start of treatment)

Kidney function

renal function within allowable ranges (tested within 15 days before the start of treatment)

Liver function

Child-Pugh score Class A; at least 700 cc of liver volume outside the treatment area

Cardiac function

no severe ECG abnormalities or active coronary artery disease within 12 months before study entry, severe/unstable angina, newly diagnosed angina or myocardial infarction, or NYHA Class II or higher congestive heart failure

Peripheral blood counts and liver and renal function within allowable ranges (tested within 15 days before the start of treatment); Child-Pugh score Class A; Presence of severe ECG abnormalities or active coronary artery disease within 12 months before study entry, severe/unstable angina, newly diagnosed angina or myocardial infarction, or New York Heart Association (NYHA) Class II or higher congestive heart failure [excluded]

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

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