HCC
Conditions
Interventions
Group A:D-TACE
Group B:D-TACE
Sponsors
Hunan Provincial Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects with advanced HCC: 1) The disease is not suitable for radical surgery / liver transplantation. 2) progression after radical surgery or liver transplantation, or ablation. 2. HCC confirmed by clinical diagnosis or histology in accordance with the 2017 health and Health Commission Standard for the diagnosis and treatment of primary liver cancer. 3. There is at least one untreated lesion that can be measured by RECIST 1.1. Subjects must have at least one previously untreated one-dimensional measurable lesion, with spiral computed tomography (CT) enhanced scanning >= 10 mm or contrast-enhanced magnetic resonance imaging (MRI) scanning >= 10 mm (malignant lymph node short diameter must be >= 15 mm) (see Appendix 1 for other details) 1) According to RECIST 1.1, accurate measurement of one dimension can be obtained; 2) the lesion has not received surgery, radiotherapy and / or local area treatment before (i.e., radiofrequency ablation [RFA], percutaneous ethanol [Pei] or acetic acid injection [Pai], cryotherapy, HIFU, TACE, TAE, etc.). 3) child Pugh A-B cirrhosis status (Appendix 2). 4. The physical state (PS) of the eastern tumor cooperative group (ECoG) was 0 or 1. See Appendix 3 for ECoG physical state scale. 5. The specific regulations of viral HCC subjects are as follows: 1) Hbv-hcc: HBV DNA of subjects with chronic HBV infection is more than 100 IU / ml, so antiviral treatment must be carried out. 2) those with positive hcv-hcc infection must receive antiviral treatment. 6. Adequate hematological function: 1) WBC >= 2000/µL 2) Neutrophils >= 1500 / µ L 3) Platelets >= 60 x 10^3 / µ L 4) Hemoglobin >= 8.5g/dl Prothrombin time (PT) - international standard ratio (INR) = 2.8 g / dl 2) Total bilirubin 50 ml / min (Cockcroft Gault formula).
Exclusion criteria
Exclusion criteria: 1. Excluding target diseases 1) The tumor was more than 50% of the liver, or the estimated survival time was less than 3 months. 2) Ascites with clinical significance is defined as follows: I) A large amount of ascites or II) any ascites requiring treatment. The clinical trial can be screened again after ascites treatment. 3) Bleeding of esophageal or gastric varices within 2 months 4) Active brain metastasis or pial metastasis. 5) History of hepatic encephalopathy. 2. Medical history and accompanying diseases 1) infection: I) Active infection excluding hepatitis B and C II) active bacterial or fungal infections requiring systematic treatment within 7 days prior to study drug administration 2) History of active heart disease, evidence as follows: I) Uncontrollable hypertension, which is defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg despite the best medical treatment II) NYHA classification for congestive heart failure > 2 (Appendix 4) III) active coronary heart disease, instability or newly diagnosed angina or myocardial infarction CTCAE Level 2. 3) Serious thrombotic or embolic events (other than HCC tumor thrombus) such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism occurred in the past 6 months 4) Any other bleeding event >= CTCAE Level 3 occurred within 8 weeks, except esophageal or gastric varices (exclusion standard 1. E.) 5) Previous allogeneic organ transplantation or allogeneic bone marrow transplantation. 6) With any serious or uncontrollable medical disorder, the investigator believes that it may increase the risk of participating in the study or giving the study drug, impair the ability of the subject to receive the treatment of the study program, or interfere with the interpretation of the study results. 3. Physical examination and laboratory test results 1) Pregnancy test positive; 2) Baseline serum sodium < 130 mmol / L; 3) Baseline serum potassium < 3.5 mmol / L (potassium supplement can be given to restore blood potassium to this level before study inclusion). 4. Sexual and reproductive status 1) Wocbp during pregnancy or lactation; 2) Women with positive pregnancy test at the time of inclusion. 5. Other exclusion standards 1) Prisoners or volunteers; 2) Subjects were forcibly detained for treatment of mental or physical illnesses (e.g., infectious diseases).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival;serious adverse events; | — |
Countries
China
Contacts
Public ContactGu Shanzhi
Hunan Provincial Tumor Hospital
Outcome results
None listed