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The incidence of colorectal cancer liver metastasis is high and the prognosis is poor. Improving the treatment effect of colorectal cancer liver metastasis is the key to improving the prognosis of colorectal cancer patients. Rigofenib is one of the standard third-line treatments for advanced colorectal cancer, but has limited efficacy. Immune checkpoint inhibitors (PD-L1 monoclonal antibody, PD-1 monoclonal antibody) have achieved good results in the treatment of various malignant tumors. In a mouse transplant tumor model of colorectal cancer, regorafenib combined with PD-1 monoclonal antibody treatment significantly improved the antitumor activity, but the efficacy rate in clinical studies was not very high, especially for liver metastases. Radiofrequency ablation (RFA) is one of the common methods for the treatment of liver metastases. RFA may improve the immune microenvironment and the efficacy of immunotherapy,and the purpose of this trial is to explore the efficacy and safety of rigofenib and terepliumab combined with RFA in patients with refractory colorectal cancer liver metastasis.
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Inclusion criteria
1)Platelet (PLT) count ≥100,000 /mm3; 2) Neutrophil count (ANC) ≥1,500 /mm3; 3) Hemoglobin (Hb) level ≥9.0 g/dl; 4) International normalized ratio (INR) ≤1.5; 5) Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN; 6) Total bilirubin (TBIL) level ≤1.5×ULN; 7) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level ≤2.5×ULN (≤5×ULN in case of liver metastasis); 8) Alkaline phosphatase level ≤2.5×ULN (≤5×ULN in case of liver metastasis); 9) Serum creatinine (Cr) level ≤1.5×ULN and creatinine clearance ≥60 ml/min; 10) Thyroid stimulating hormone (TSH) ≤ULN; 11) Normal serum free thyroid hormone (T4); 12) Normal serum free triiodothyronine (T3); 13) Serum amylase ≤1.5×ULN; 15) Lipase ≤1.5×ULN.
Females of child bearing age must have a negative pregnancy test, and have to take contraception measures and avoid breast feeding during the study and for 3 months after the last dose; male subjects must agree to taken contraception measures during the study and for 3 months after the last dose.
Able to understand and willing to sign written informed consent form.
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32 participants in 1 patient group
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Central trial contact
Zhiqiang Wang
Data sourced from clinicaltrials.gov
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