hepatocellular carcinoma
Conditions
Interventions
Sponsors
Beijing Cacer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: All selected subjects must meet the following relevant conditions: 1. the patient or legal representative voluntarily participate, and signing the patient's informed consent form; 2. patients aged 18-80 years of age (subject to the date of signing the informed consent form); 3. patients with primary or secondary solid tumors (lung cancer, liver cancer) who have been clinically diagnosed, and the lesions can be measured, requiring minimally invasive surgery; 4. the patient cannot tolerate surgical resection due to poor cardiopulmonary function or advanced age; 5. refused surgical resection; 6. ECOG-PS score is 2 or less; 7. expected lifetime more than three months; 8. people who can correctly describe and are willing to participate in follow-up survey. Primary and metastatic liver cancer: 1. Pathological diagnosis of hepatobiliary cell carcinoma or mixed cell carcinoma; or metastatic liver cancer with clear pathological diagnosis; or diagnosis of hepatocellular carcinoma according to any of the following A/B diagnostic criteria, the diagnostic criteria refer to the American Association for the Study of Liver Diseases (AASLD) 2010 Updated "Clinical Guidelines for Hepatocellular Carcinoma": A: pathological diagnosis of hepatocellular carcinoma; B: clinical diagnosis, which can be diagnosed by satisfying the following three items: evidence of cirrhosis and HBV/HCV infection; liver occupying diameter was greater than 1 cm; typical Imaging characteristics of hepatocellular carcinoma; 2. have plenty of organ function, which can meet the following conditions: Blood routine: white blood cells=3.0×109/L, neutrophils=1.5×109/L, platelets=80×109/L, hemoglobin=9.0g/dL. Liver function: total bilirubin=2.0×ULN; ALT/AST =2.5×ULN without hepatic metastasis; ALT/AST=5×ULN for liver metastasis. Coagulation function: International normalized ratio (INR)=1.5×ULN, and activated partial thromboplastin time (APTT)=1.5×ULN; (patients who are receiving anticoagulant therapy, take anticoagulant drugs such as aspirin, warfarin, clopidogrel, etc., it is necessary to stop the drug for at least 5-7 days in principle. The researchers judge that INR and APTT are safe and effective within the scope of treatment.) Renal function: serum creatinine=1.5×ULN. Curative ablation treatment: 1. single tumor, maximum diameter is=5 cm; Or the number of tumors is=3, and the maximum diameter is=3cm. 2. no blood vessels, bile ducts and the adjacent organ invasion and distant metastases. Palliative ablation [13] treatment: 1. a single tumor with a diameter>5 cm that cannot be surgically removed or a multiple tumor with a maximum diameter<3 cm; 2. For the invasion of blood vessels, bile ducts and adjacent organs, as well as distant metastasis, the researchers need to organize a multidisciplinary discussion and decide.
Exclusion criteria
Exclusion criteria: If find one of the following relative conditions, the subject will not be able to participate in the clinical study: 1. There are traumatic injuries in the chest and abdomen that can cause surgical infection; 2. patients with severe infections and severe heart and brain diseases; 3. have a history of immunodeficiency, including HIV testing positive (enzyme-linked immunosorbent assay and Western blotting); 4. pregnant or lactating women; 5. similar minimally invasive surgery was performed within 1 month; 6. those who have undergone radiotherapy or chemotherapy within 1 month; 7. patients who are considered unsuitable for this clinical study by the researcher. Primary liver cancer and metastatic liver cancer: 1. there are esophageal (stomach) varices bleeding in the past three months, and severe gastric ulcer in the past; 2. severe liver and kidney, heart, lung and brain and other major organ failures; 3. refractory massive ascites, dyscrasia; 4. the tumor is close to the hepatic hilum and is not suitable for local ablation; 5. associated with portal vein and primary branch tumor thrombus or adjacent organs invasion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local efficiency after tumor ablation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local effective control rate after tumor ablation treatment at 3 months and 6 months after cryoablation;Local recurrence rate;Quality of life score;Overall survival;progression-free survival; | — |
Countries
China
Contacts
Public ContactXu Zhu, Yinghua Zou
Beijing Cacer Hospital
Outcome results
None listed