colorectal cancer with liver metastasis
Conditions
Interventions
SBRT combined with placebo treatment group:SBRT combined with placebo treatment
SBRT combined with immune checkpoint inhibitor treatment group:SBRT combined with immune checkpoint inhibitor treatment
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age =18 years old and =75 years old; 2) The primary lesion was confirmed by pathological data; Liver metastases with at least one imaging data [computed tomography (CT), magnetic resonance imaging (MRI), MRI) or positron emission tomography-computed tomography (PET-CT) were used to confirm the diagnosis. 3) Patients with CRLM were eligible for SBRT if the total number of liver metastases was less than or equal to 3, the maximum diameter of liver metastases was less than 5cm, and the distance from empty organs was more than 1cm, and at least one of them was evaluable. 4) good general condition, ECOG score =2 or KPS score =70. 5) Child-Pugh A or B liver function, other laboratory tests: 1. Neutrophil =1.5×109/L (2) Platelet =50×109/L 3. Hemoglobin =90g/L (no blood transfusion or erythropoietin (EPO) dependence within 2 weeks) 4. Serum creatinine =1.5 times ULN or calculated creatinine clearance = 60 ml/min (Cockcroft-Gault formula) 5.AST =2.5×ULN, ALT =2.5×ULN (6) TSH, FT3 and FT4 were within ±10% of normal value 7. Coagulation function: international normalized ratio (INR) = 2 times ULN and activated partial thromboplastin time (APTT) = 1.5 times ULN 6) estimated survival time > 3 months; 7) no history of radiotherapy. 8) provide written informed consent and be able to comply with protocol-specified visits and procedures. 9) Female subjects of childbearing age or male subjects whose sexual partner is a female of childbearing age should use effective contraception during the entire treatment period and for 6 months after the treatment period.
Exclusion criteria
Exclusion criteria: 1) history of hepatic encephalopathy or liver transplantation. 2) presence of clinical symptoms or symptoms of pleural effusion, ascites or pericardial effusion requiring drainage. 3) patients with acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus (HBV) DNA>2000IU/ml or 10^4 copies /ml; Hepatitis C virus (HCV) RNA> 10^3 copies /ml; Both hepatitis B surface antigen (HbsAg) and anti-HCV antibody were positive. 4) presence of symptomatic central nervous system metastases. Patients with asymptomatic or treatment-stable brain metastases who met all the following criteria were eligible for inclusion in the study: measurable disease outside the central nervous system; No metastasis was found in midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord. Maintain clinical stable state for =4 weeks; Glucocorticoids were discontinued 2 weeks before the first dose. 5) History of interstitial pneumonia, drug-induced pneumonia, idiopathic pneumonia, or active pneumonia. Radiation pneumonitis in the radiotherapy area was allowed. 6) patients with active pulmonary tuberculosis (TB) who were receiving anti-TB treatment or had received anti-TB treatment within 1 year before the first treatment. 7) human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive). 8) presence of severe active or poorly controlled infections; Or severe infection within 4 weeks before the first dose of medication, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. 9) a history of active autoimmune disease or known primary immunodeficiency requiring systemic treatment. The presence of autoimmune disease in patients who were positive only for autoimmune antibodies was determined at the discretion of the investigator. 10) received live attenuated vaccine within the previous 4 weeks or planned to during the study. 11) have had major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures within the previous 4 weeks. 12) the presence of uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary reactions to cancer, leading to high medical risk and/or uncertainty in survival evaluation. 13) have other acute or chronic medical conditions, psychiatric conditions, or abnormal laboratory values that could increase the risk of medication administration, interfere with the study results, or, in the investigator's judgment, exclude the patient from the study. 14) diagnosed with a second primary malignancy within 5 years before the first dose, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection in situ carcinoma. If other malignancies were diagnosed more than 5 years before treatment, pathological and cytologic diagnosis of liver metastases was required. 15) female patients who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control and survival rates; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total effective rate; | — |
Countries
China
Contacts
Public ContactZuolin Xiang
Shanghai East Hospital
Outcome results
None listed