Hepatocellular carcinoma
Conditions
Interventions
Sponsors
PLA 307 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old male or female hepatocellular carcinoma patient (including 18 and 75 years old); 2. The diagnosis of primary hepatocellular carcinoma or metastatic liver cancer, and conforming to any of the following three diagnostic criteria can be entered into the group: (1) In accordance with any of the following A/B diagnostic criteria, it can be diagnosed as hepatocellular carcinoma, and the diagnostic criteria refer to the clinical guide for hepatocellular carcinoma (HCC) updated in 2010 by the American association for the study of liver diseases (AASLD): 1) Pathological diagnosis: biopsy or surgical removal of tissue specimens of liver space occupying lesions, and hepatocellular carcinoma diagnosed by histopathology and / or cytological examination; 2) Clinical diagnosis: in all solid tumors, only hepatocellular carcinoma can be diagnosed by clinical diagnostic criteria, which can be diagnosed as following 3 items: Evidence of cirrhosis and HBV and/or HCV infection; The diameter of liver occupying lesions > 1cm; Typical imaging features for hepatocellular carcinoma (HCC): four phase multi slice CT scans and/or dynamic contrast enhanced MRI examination showed that the hepatic occupying lesions for fast heterogeneous vascular enhancement in the arterial phase (Arterial hypervascularity), and venous phase and delayed phase elution (Venous or delayed phase fast washout). (2) Pathological diagnosis of hepatic cholangiocarcinoma or mixed cell carcinoma; (3) The pathological diagnosis of metastatic liver cancer is clear, and after systemic treatment, there is no extrahepatic lesion, or the disease is stable or disappeared outside the liver, which is in line with the local treatment conditions of the liver; 2. Solitary tumor is less than 5cm; or the tumor number is less than 3, the maximum diameter of each tumor is less than 3cm; 3. Liver function classification child-pugh is A or B; 4. The value of ECOG-PS is less than 2; 5. Expected survival over three months; 6. No other clinical trial has been taken in 3 months 7. Patients refuse surgical treatment; 8. The subject will sign the ICF.
Exclusion criteria
Exclusion criteria: 1. The patients with esophageal (gastric fundus) variceal bleeding and severe gastric ulcer; 2. Severe failure on liver, kidney, cardiopulmonary and brain; 3. The obstinate massive ascites and dyscrasia; 4. The tumor near the hepatic portal is not suitable for local ablation; 5. Accompanied by vascular tumor thrombus or invasion of adjacent organs; 6. Lymphatic or distant metastasis; 7. Active infection, especially the inflammation of the biliary tract system, etc. 8. History of immunodeficiency, including HIV testing (enzyme-linked immunoassay and Western blotting) is positive; 9. The target therapy drug, chemotherapy, radiotherapy, interventional therapy, ablation therapy and surgical treatment were used within one month before cyroablation treatment. 10. Hemogram: platelets 3 mg or above or 51.3 umol/L; Kidney: creatinine > 1.25 times as high as the upper limit of normal value; 11. The blood coagulation (PT, TT and APTT) > 2.5 times as high as the upper limit of normal value; 12. Severe brain disease or diffuse type of liver cancer and other mental disorders; 13. Often use sedatives, sleeping pills, tranquilizers or other addictive drugs; 14. Pregnant or lactating women; 15. It is impossible to judge the curative effect; 16. Other conditions that were not suitable for the group were determined by the researchers, such as the ability to tolerate the surgery, the difficulty of follow-up, and other serious diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The local effective control rate after 4 weeks of ablation after cryoablation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The effects of immune function; | — |
Countries
China
Contacts
Public ContactWuwei Yang
Tumor treatment minimally invasive Department, 307 Hospital, PLA
Outcome results
None listed