Hepatocellular carcinoma
Conditions
Interventions
Contrastive group:Epirubicin 30mg/m2, TACE operation
test team:LBP30mg/m2, TACE operation
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The age is 18-70 years old, and the sex is not limited. 2, Confirmed by histopathology or clinical diagnosis as hepatocellular carcinoma [guideline for diagnosis and treatment of primary liver cancer (2017Annual Edition); 3. The expected survival time is more than 3 months. 4. At least one measurable lesion (according to mRECIST); 5. Some patients in stage IIb, IIIa and IIIb may be surgically removed, but because of other sources Stage Ib and IIa disease, such as advanced age, severe cirrhosis, etc., unable or unwilling to undergo surgery People; 6. Liver function Child Pugh A or B grade; 7. ECOG score 0-2; 8. Liver cancer has not been treated with surgery, chemotherapy, radiotherapy or interventional therapy (including refrigeration, radiofrequency, and radiotherapy).Wave) and other treatment of the initial treatment of patients; 9. The index of laboratory examination meets the following requirements: Bone marrow function: absolute count of blood neutrophils (ANC) is more than 1.5 x 10^9/L; platelets. (PLT) more than 60 x 109/L; hemoglobin (HB) is equal to or equal to 90g/L; Renal function: Cr < ULN (upper limit of normal value), endogenous creatinine clearance (Ccr) is more than 55. Ml/min; Liver function: serum total bilirubin (TBIL), direct bilirubin (DBIL) is less than normal upper limit. (ULN) x 2; alanine aminotransferase (ALT) and aspartate aminotransferase(AST) < < ULN * 5; Coagulation function: the international normalized ratio (INR) of prothrombin time is less than ULN * 1.5. 10. Female: contraception during and after 6 months of treatment; non lactation; male: duration of treatment and 6 months after the end of contraception; 11. The patient voluntarily signed and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Any contraindication for TACE treatment [criteria for diagnosis and treatment of primary liver cancer] (2017 Edition); 2. Arteriovenous fistula occurred during the angiography; 3. In the past 5 years, it suffered from malignant tumors of other histologic sources, except for G treated cervical cancer and basal cell carcinoma or squamous cell carcinoma; 4. serious cardiovascular disease, including internal medicine treatment of uncontrolled hypertension, unstable angina, the history of myocardial infarction in the last 6 months, >NYHA II of congestive heart failure, serious arrhythmia, and pericardial effusion, etc.; 5. In the first 4 weeks of the group, there was bleeding of grade CTCAE or 3; 6. there is a serious acute infection, and it is not controlled; or there is a purulent and chronic infection, the wound is not healed, but the patients who do not include hepatitis need routine use of antiviral treatment. 7. Over the past 4 weeks, other clinical trials have been treated; 8. Allergy to any test drug or mannitol (excipient); 9. During the first 4 weeks of the operation, major operations or surgical wounds were not fully healed; 10. suffering from mental illness and poor compliance; 11. Researchers believe that patients should not participate in other aspects of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR or DCR;One year survival rate and two-year survival rate;Safety; | — |
Countries
China
Contacts
Public ContactZhi-Ping Yan
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed