Primary liver cancer metastasis to the lungs
Conditions
Interventions
test group:arsenic trioxide
control group:Blank
Sponsors
Fudan University affiliated Zhongshan Hospital Radioactive Intervention Department
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or 75 years old of the following cases (male or female); 2. the patients life expectancy at least for 3 months; 3. accord with liver cell carcinoma diagnosis standard (EASL of HCC diagnosis standard): cytohistology standard non-invasive standard (limited to patients with cirrhosis) (1) radioactive diagnosis standard: two kinds of image technology obtains the consistent conclusion lesions > 2 cm, rich in arteries; (2) combined with diagnosis standard: a kind of image technology with the AFP lesions > 2 cm, rich in arteries AFP level >=400 ug/L* can consider four technology: ultrasonic imaging, spiral CT, MRI and angiography; 4. clear lung metastatic carcinoma imaging diagnosis (chest x-rays, CT/MRI), except to primary lung cancer; patients with pulmonary metastasis lesions must have at least one tumor lesions, and at the same time meet the following two standards: (1) according to solid tumor response evaluation criteria in solid tumors (RECIST), lesions at least a lines can be accurate measurement; (2) target lesion always didn't accept any local treatment (including surgery, radiotherapy, chemotherapy embolism, radiofrequency ablation, percutaneous ethanol injection and freezing ablation);Recurrence of hepatocellular carcinoma (HCC), liver lesions received local treatment of patients can be integrated into, including surgery, radiotherapy, and hepatic artery embolism, embolism chemotherapy, radiofrequency ablation, percutaneous ethanol injection or frozen ablation, but must clear up the lung transfer target lesion is not within the scope of previous treatment; Once the patient if at the same time merge adrenal, bone, skin metastases are intended to be incorporated into this research scope, bone metastasis can also accept radiation therapy not systemic treatment; Stuff in the Eastern part of patients with tumor clinical trials Group (Eastern Co - operative Oncology Group, ECOG) function status to 0, 1 or 2; liver function Child - Pugh classification for class A or B level of patients;? laboratory index is as follows:1) platelet count >=60*10^9/L; (2) hemoglobin>=8.5 g/dl; (3) albumin >=3.0 g/dl; (4) total bilirubin acuities 3 mg/dl; (5) ALT and AST were less than three times the normal limit; (6) serum creatinine is less than 1.5 times the normal of the upper limit; (7) prothrombin time international standardization ratio (PT - INR) < = 2.3 or prothrombin time (PT) more than normal compared 6 seconds; (8) into the clinical research of the patients informed consent must be signed, patients should know he/she shall have the right at any time to test, and will not affect the subsequent treatment.
Exclusion criteria
Exclusion criteria: 1. expected survival period less than 3 months; 2. intrahepatic primary lesions did not get effective control, recent lesions in the liver increased obviously (a month tumor diameter increased 25%), or quantity increase; 3. merger of partal vein carcinoma bolt, or inferior vena cava carcinoma bolt; 4. known or suspected to be try drug allergy or to give this test related with any drug allergies; 5. at least 4 weeks received chemotherapy, target drug therapy, or contains the chemotherapy drug interention (TACE/TAI); 6. before now or with a primary stove or histological does not comply with the liver cell cancer tumor; 7. congestive heart failure > New York heart association (NYHA) level II; 8. activity of coronary artery disease (into the group of the first six months ago happen myocardial infarction patients can into the group); 9. arrhythmia need to accept anti-arrhythmic therapy (B receptor - blockers, calcium ion antagonist or digoxin except); 10. can't control hypertension (even using three kinds of antihypertensive drug treatment diastolic pressure still can't control in 90 MMHG the following; 11. activity clinical serious infection (> level 2 NCI - CTCAE3.0 version); 12. exist active tuberculosis, or not be excluded pulmonary tuberculosis in the lung lesions. 13. known central nervous system tumors, including brain metastatic tumor; 14. the patient group there were 30 days before clinical obvious gastrointestinal bleeding, 15. chronic renal failure; 16. any unstable condition or is likely to endanger the patient safety and he/she to research compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR of Lung metastases;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| TTP;OS; | — |
Countries
China
Contacts
Public Contactjiahua wang
Outcome results
None listed