Colorectal cancer
Conditions
Interventions
Experimental group:HIFU + Suliimab + Furuquintinib
Sponsors
Zhongshan Hospital (Xiamen), Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The patient must meet the following criteria to be eligible for the study: 1 . Age >= 18 years and 3 months; 6. Adequate renal function: Creatinine (Cr) = 60 mL/min/1.73 m^2; 7. Adequate liver function: Total bilirubin = 100 × 10^9/L, absolute neutrophil count (ANC) >= 1.5 × 10^9/L, hemoglobin >= 9 g/dL (without receiving any auxiliary treatments such as erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days, and no blood transfusion including red blood cell and platelet transfusion within at least 7 days before the first administration); 9. Prothrombin time/activated partial thromboplastin time (PT/PTT) 9 is defined as high tumor burden, and TBS <= 9 is defined as low tumor burden. Patients with liver lesions TBS <= 9.
Exclusion criteria
Exclusion criteria: Patients who exhibit any of the following conditions during the screening process will not be eligible to be included in this study: 1. Have undergone major surgery or radiotherapy for liver metastases within 4 weeks prior to enrollment; 2. Have active, known or suspected autoimmune diseases; 3. Have had congestive heart failure or symptomatic coronary artery disease within 3 months prior to enrollment; 4. Have experienced a cerebrovascular accident within the past 6 months; 5. Have had clinically significant bleeding, bleeding events or thromboembolic diseases within 6 months prior to enrollment; 6. Have a history of intestinal perforation or intestinal obstruction; 7. Have a history of non-infectious pneumonia requiring steroid treatment or currently have pneumonia; 8. Have a known history of human immunodeficiency virus (HIV) infection. Active hepatitis B or hepatitis C in the subjects. (Unless the subjects received at least 14 days of antiviral treatment before the first administration of the study drug and passed the hepatitis B virus (HBV) DNA titer test (not higher than 500 IU/mL or 2500 copies [cps]/mL) and hepatitis C virus (HCV) RNA test (not exceeding the detection limit of the assay), they can be enrolled in the trial and are willing to continue receiving effective antiviral treatment during the study); 9. Have severely impaired lung function or a history of interstitial lung disease; 10. Have been diagnosed with concurrent malignant tumors within the past 2 years (except for fully treated non-melanoma skin cancer, superficial bladder transitional cell carcinoma, and cervical carcinoma in situ [CIS]) or any currently active malignant tumors; 11. Have any condition, treatment, or laboratory abnormality that may confound the study results, interfere with the subject's participation in the entire study process, or that the investigator considers not in the best interests of the subject to participate in this study; 12. Have a known condition that may affect trial compliance, including mental illness or disorder; 13. Have taken systemic corticosteroids (>10 mg daily prednisone equivalent) or other systemic immunosuppressive drugs (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs) within 2 weeks prior to the first administration of the study drug, and local, ocular, intra-articular, nasal, and inhaled corticosteroids are allowed; 14. Have a known history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, or glomerulonephritis, except for autoimmune-related hypothyroidism with stable hormone replacement therapy; 15. Have a previous history of immunodeficiency, including having other acquired or congenital immune deficiency diseases, or a history of organ transplantation, or a history of allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation; 16. Other situations that the investigator deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression-Free Survival;Duration of Response; | — |
Countries
China
Contacts
Public ContactFeng Shen
Zhongshan Hospital (Xiamen), Fudan University
Outcome results
None listed