A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM

This is a single-center, single-arm, prospective study to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal cancer liver metastasis. The study includes 20 patients with colorectal cancer liver metastasis that has failed first-line therapy and is unresectable. All patients will receive multi-mode ablation to achieve complete remission of liver lesions followed by systemic therapy including PD-1 inhibitor.

This study will provide preliminary data on the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal cancer liver metastasis, which could lead to larger randomized trials.

Inclusion criteria

• Age 18-75 years, gender not specified;
• Pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection;
• In the case of an unresectable primary tumor or recurrence, the absence of serious complications such as bleeding or obstruction;
• Failure of first-line treatment, with disease progression or new liver metastases;
• No more than 5 liver lesions, with single lesion diameter ≤ 3cm;
• For those who have received previous chemotherapy, radiotherapy or local liver treatment, the interval from the last systemic treatment or local liver treatment should be at least 1 month;
• Child-Pugh A or B; bilirubin ≤ 3.0 mg/dL, creatinine ≤ 2.5 mg/dL, white blood cell count ≥ 2.0 ×10^9/L, platelets ≥ 100 ×10^9/L;
• ECOG PS ≤ 2;
• Willing to accept subsequent treatment regimens that include anti-PD-1 monoclonal antibody therapy.

Exclusion criteria

• Liver function Child-Pugh class C;
• Expected survival < 3 months;
• Major organ insufficiency or failure;
• Active infection;
• Irreversible coagulation disorders;
• Refractory massive ascites, pleural effusion or cachexia;
• Unable to cooperate with treatment;
• Any other factors deemed inappropriate for inclusion or that may affect the subject's participation in the study, as determined by the investigator.