Colorectal cancer
Conditions
Interventions
Test group:SBRT+Camrelizumab+Trifluridine
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with colorectal cancer confirmed by colonoscopy and liver metastases confirmed by liver MRI with liver metastases that are unresectable, unsuitable for surgery or radiofrequency ablation, or who refuse surgery 2. Patients ranged in age from 18 to 75 years 3. According to RECIST v1.1 criteria, the patient had at least one measurable lesion in the liver 4. The Eastern Oncology Collaborative Group (ECOG) scored 0 or 1 5. At least one liver metastatic tumor was larger than 3cm 6. All enrolled patients required tumor pathologic examination (molecular biological method or immunohistochemical method) to confirm MSS or pMMR patients 7. Failure or intolerance of at least two lines of chemotherapy (including 5-FU, irinotecan, oxaliplatin based chemotherapy regimen), or inability to perform/refuse first - and second-line standard therapy 8. Measurable lesions at the site of extrahepatic metastases in patients with extrahepatic metastases (RECIST V1.1 criteria) 9. Liver child-pugh grades A--B7 10. Patients who have not previously received radiotherapy for liver or rectal or other tumors within 6 months may have received local treatment for liver metastases such as surgery, radiofrequency ablation, and cryotherapy, but the local treatment time must be completed within 4 weeks or more 11. Bone marrow, liver and renal function: absolute neutrophil count (ANC) =1.5×109/L, hemoglobin =85g/L, platelets =80× 109/L, serum creatinine =176.8µmol/L, AST and ALT=5 times the upper limit of normal (ULN); Total bilirubin =51µmol/L, PT <4 seconds longer than normal or normal (INR<1.7), albumin greater than 30g/dl
Exclusion criteria
Exclusion criteria: 1. The patient had received other systemic treatments within 4 weeks prior to the first treatment 2. The patient has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient had vitiligo; Those with complete remission of asthma in childhood can be included without any intervention in adulthood; Patients with asthma requiring medical intervention with bronchodilators are not included) 3. Patients who were taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (doses >10mg/ day of prednisone or other therapeutic hormones) and continued to use within 2 weeks prior to enrollment 4. Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or any other antibody or drug that specifically targets T cell co-stimulation or immune checkpoint pathways 5. He had been treated with trifluridine within the previous four weeks 6. Patients with any severe and/or uncontrolled disease, including: patients with unsatisfactory blood pressure control (systolic =150mmHg or diastolic =100 mmHg); Patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmias (including QT interval =480ms), and grade I cardiac insufficiency 7; Active or uncontrolled severe infection 8. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA=104 copy numbers /ml or 2000IU/ml), or hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower detection limit of analytical methods) 9. Urine routine indicated urine protein =++, and confirmed 24-hour urine protein quantity > 1.0g 10. Pregnant or lactating women 11. Patients with other malignancies within 5 years 12. Patients with a history of psychotropic substance abuse who are unable to abstain or have mental disorders 13. Patients who have participated in clinical trials of other drugs within four weeks 14. Patients with concomitant diseases that, in the investigator's judgment, seriously endanger patient safety or interfere with the patient's completion of the study 15. The researchers did not consider it suitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival;Safety: Incidence of adverse events (AE), quality of life score EQ-5D-5L;Exploration of biomarkers related to colorectal cancer;Changes in proportion of immune cell subsets before and after treatment: CD8+T cells, CD4+T cells, B cells, NK cells, etc; | — |
Countries
China
Contacts
Public ContactZhiyong Zhang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed