Liver malignant tumors
Conditions
Interventions
MRI-guided Group:Conduct liver tumor microwave ablation under MRI.
CT-guided Group:Conduct liver tumor microwave ablation under CT.
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the informed consent form; 2. The age of the patient is between 18 and 75 years old; 3. Primary liver cancer or colorectal liver metastases with a clear diagnosis or recurrence after initial diagnosis or postoperative recurrence; 4. The diameter of the target lesion for intrahepatic ablation is =1.5×10^9/L; platelets>=70×10^9/L; hemoglobin >=90 g/L; b. Biochemical examination: serum albumin >=30 g/L; serum total bilirubin 50 ml/mn (Cockcroft-Gault formula is as follows): Male: Cr clearance = ((140-age)× weight)/(72× blood Cr); Female: Cr clearance = ((140-age)× body weight)/(72× blood Cr)×0.85 body weight unit: kg; Blood CR unit: mg/ml; c. The international normalized ratio (NR) =2+, 24-hour (h) urine protein quantification can be performed, and 24-hour urine protein quantification <1.0g can be enrolled).
Exclusion criteria
Exclusion criteria: 1. Portal artery cancer thrombus reaches or exceeds the portal vein trunk and is combined with complete embolization of the portal vein trunk or complete embolization of the left and right branches of the portal vein; 2. Patients with severe allergy to iodine contrast medium and unable to undergo enhanced scanning; 3. Patients who are ready to undergo or have previously received organ or allogeneic bone marrow transplantation; 4. The patient has an active infection, has an unexplained fever within 1 week before randomization>=38.5°C, or the white blood cell count >15×10^9/L during the screening period; Therapeutic antibiotics given orally or intravenously within 2 weeks prior to randomization (except for prophylactic antibiotics administered intravenously for no more than 48 hours); 5. Patients with congenital or acquired immunodeficiency (such as HIV infection); 6. Known hereditary or acquired bleeding (such as coagulation dysfunction) and thrombotic tendency, such as hemophilia patients; Currently receiving full-dose oral or injectable anticoagulant drugs or thrombolytic drugs for therapeutic purposes (prophylactic use of low-dose aspirin is allowed, etc.); 7. Have uncontrolled cardiac clinical symptoms or diseases such as: (1) Cardiac insufficiency or color Doppler echocardiography above the New York Heart Association (NYHA) (see Annex 3) criteria: LVEF (left ventricular ejection fraction) 450ms (male); QTc>470ms (female); 8. Have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure >=140mmHg or diastolic blood pressure >=90mmHg) (based on the average of BP readings obtained from >=2 measurements), allowing the above parameters to be achieved through the use of antihypertensive therapy; previous hypertensive crisis or hypertensive encephalopathy; 9. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to randomization; 10. Severe, non-healing or dehiscence wounds and active ulcers or untreated fractures; 11. Major surgical treatment (other than diagnosis) within 4 weeks prior to randomization or anticipated need for major surgical treatment during the study; 12. The patient took bevacizumab within 4 weeks; 13. Intrahepatic target lesions to be ablated have used vascular interventional therapy within 3 months; 14. Intrahepatic lesions have received radiotherapy or radioactive seed implantation therapy; 15. The patient has factors that are not suitable for MRI/CT examination; Patient has participated in other clinical studies that conflict with this study; 17. Other factors that the investigator considers unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Ablation Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local Tumor Progression Rate;Duration of Procedure;Radiation dosage; | — |
Countries
China
Contacts
Public ContactWeijun Fan
Sun Yat-sen University Cancer Center
Outcome results
None listed