liver metastasis after colorectal cancer surgery
Conditions
Interventions
Sponsors
Changhai Hospital of Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18-80 years old; 2. Patients with recurrence of colorectal cancer confirmed by pathology; 3. Have received = second-line standard chemotherapy and have failed treatment. The definition of "treatment failure": (1) disease progression during the course of treatment or disease progression within 3 months after the last treatment, with clear evidence of imaging or clinical progress; (2) withdrawal from the standard chemotherapy due to inability to tolerate adverse events of chemotherapy. Note: 1) Treatment of each line of advanced disease includes one or more drugs with a time of = 1 cycle or more. 2) If the disease progresses within = 6 months after or during adjuvant therapy/neoadjuvant therapy, the treatment is considered to be the first-line treatment failure for advanced disease. 3) Permissive pre-treatment is chemotherapy combined with monoclonal anti-angiogenic drugs (including but not limited to bevacizumab, panitumumab, aflibercept); 4. According to the RECIST 1.1 criteria, patients have at least one target lesion for hepatic metastases with a measurable diameter (CT lesions with tumor diameter = 10 mm, lymph node lesions with CT scan shorter diameter =15 mm, and scan thickness less than 5 mm; and Not received local treatment); 5. ECOG : 0~2 points; 6. Expected survival period = 3 months; 7. The main organs function well. The relevant examination indicators meet the following requirements within 14 days before enrollment: a) Routine blood tests: (1) Hemoglobin = 90 g/L (without transfusion in 14 days); (2) Neutrophil count > 1.5× 10^9/L; (3) Platelet count = 80×10^9/L; Total bilirubin = 1.5×ULN (upper limit of normal value); Blood alanine aminotransferase (ALT) or Blood grass Transaminase (AST) =5×ULN; Endogenous creatinine clearance = 60 ml/min (Cockcroft-Gault formula); Child-Pugh liver function rating: A grade or better B grade (=7 points) ; 8. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment, and the result is negative, and they are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, surgical sterilisation should be performed, or agree to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug; 9. Subjects voluntarily joined the study, signed informed consent, and adhered well to follow-up.
Exclusion criteria
Exclusion criteria: 1. TACE and any other local treatment (including but not limited to surgery, radiotherapy, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within 4 weeks prior to the study; 2. In the past (within 5 years) or at the same time suffering from other untreated malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 3. People with high blood pressure who are unable to fall within the normal range after treatment with antihypertensive drugs (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); 4. Arrhythmia with poor grade II or higher myocardial ischemia or myocardial infarction and poor control (including QTSc men = 450 ms, women = 470 ms); 5. In accordance with NYHA criteria III-IV heart failure or cardiac ultrasound examination: LVEF (left ventricular ejection fraction) 1.5 or prothrombin time (PT)>ULN+4 seconds) with a tendency to hemorrhage or receiving thrombolytic or anticoagulant therapy; 10. Patients with central nervous system metastases or known brain metastases have occurred; 11. Patients with objective evidence of previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impaired pulmonary function; 12. Urinary urine showed that urinary protein = ++ or confirmed 24-hour urinary protein quantification> 1.0 g; 13. Those who are allergic to the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objective remission rate; | — |
Countries
China
Contacts
Public ContactYANG JIJIN
Outcome results
None listed