colorectal cancer
Conditions
Interventions
Transhepatic arterial embolization chemotherapy Bevacizumab tislelizumab group:None
Regorafenib or TAS102:None
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of science and technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand this study and voluntarily sign the informed consent form; 2. Age 18 ~ 75 years old, regardless of gender; 3. Patients with colorectal cancer diagnosed by histopathology with liver metastasis (at least 1 measurable lesion); 4. Good physical condition: ECOG score is 0-1; 5. Previously received fluorouracil, oxaliplatin and irinotecan; With or without anti VEGF monoclonal antibody (bevacizumab); For RAS (KRAS / NRAS) wt subjects, combined with anti EGFR MAb (cetuximab), i.e. received standard first-line and second-line chemotherapy; 6. There is no major organ dysfunction, and the laboratory examination meets the basic requirements of chemotherapy, namely: 1) Neutrophil count >= 1.5 × 10^9/L 2) Platelet count >= 90 × 10^9/L 3) HB>=90g/L; 4) Serum AST and alt <= 1.5 times the upper limit of normal value ULN (AST and alt <= 5.0 times ULN in case of liver metastasis); 5) Total bilirubin <= 1.5 times ULN; 6) Serum creatinine <= 1.5 times ULN; 7) ECG Q-T interval <= 450ms; 8) Serum electrolytes (sodium, potassium, chlorine and total calcium) were normal; 7. Women of childbearing age should agree to use contraceptives during the study period and within 3 months after the end of the study; Negative serum or urine pregnancy test within 7 days before study enrollment, and must be non lactating patients; Men should agree to use contraception during the study period and within 3 months after the end of the study period; 8. There were no other treatment contraindications before treatment. The patients volunteered to join the group with good compliance and can cooperate with the experimental observation.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Women of childbearing age were positive in the baseline pregnancy test; 3. Other malignant tumors (except basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or breast cancer) in the past 5 years; 4. Uncontrolled pleural effusion, pericardial effusion or ascites; 5. Severe cardiovascular diseases such as symptomatic coronary heart disease, congestive heart failure = grade II, arrhythmia out of control and myocardial infarction occurred within 12 months before admission; 6. With gastroduodenal obstruction / bleeding, digestive dysfunction or malabsorption syndrome; 7. Complicated with severe uncontrolled infection or other severe uncontrolled concomitant diseases, moderate or severe renal injury; 8. Allergic reactions to the drugs used in this study; 9. Steroid or other systemic immunosuppressive therapy was used 14 days before admission; 10. Patients who received study drug treatment within 4 weeks before enrollment (participating in other clinical trials). 11. Active autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment). Patients with hypothyroidism who only need hormone replacement therapy and patients with skin diseases without systemic treatment (such as vitiligo, psoriasis or hair loss) can be selected. 12. History of primary immunodeficiency. 13. Immunosuppressive drugs were used within 4 weeks before the first dose of the study treatment, excluding systemic glucocorticoids of local or physiological dose (i.e. prednisone not more than 10mg/ day or other glucocorticoids of the same dose), through nasal spray, inhalation or other ways, or hormones used to prevent contrast agent allergy. 14. Live attenuated vaccine was received within 4 weeks before or during the first dose of study treatment. 15. Active tuberculosis is known. 16. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 17. HIV antibody positive, active hepatitis B or C (hepatitis B: HBsAg positive, HBV DNA >=2000 copy number / ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment); 18. According to the judgment of the researcher, other factors that may affect the subject's safety or test compliance. For example, serious diseases requiring comprehensive treatment (including mental diseases), serious laboratory abnormalities or other family or social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR (Overall Response Rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| OS (Overall survival);PFS (Progress Free Survival);DCR (Disease Control Rate);AE (Adverse Effect);QOL (Quality of Life); | — |
Countries
China
Contacts
Public ContactFu Qiang
Tongji Hospital, Tongji Medical College, Huazhong University of science and technology
Outcome results
None listed