Hepatocellular carcinoma
Conditions
Interventions
experimental group:hepatic artery infusion chemotherapy with donafenib
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-75 years, male or female; 2.Naive patients with hepatocellular carcinoma (HCC) pathologically diagnosed who have underwent radical hepatectomy 4-8 weeks before enrollment; 3.Single tumor >= 5cm with microvascular invasion; 4.Liver function grade: Child-Pugh GRADE A or better grade B (=100 g/L; (2)Absolute neutrophil count(ANC)>=1.5x10^9 /L; (3)Platelet count(PLT)>=75x10^9/L; (4)Serum albumin (ALB)>=28g/L; (5)Alanine transaminase (ALT), aspartate aminotransferase(AST)=50mL/min; (8)International standard ratio (INR) or prothrombin time (PT) <=1.5xULN; Activated partial coagulation time (APTT) <=1.5xULN. 8.Subjects voluntarily enrolled in the study, signed an informed consent form, and can understand and follow the test protocol medication, follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients who have received any hepatocellular carcinoma-related systemic therapy before enrollment; including targeted therapy such as sorafenib, lenvatinib, and regorafenib, or immunomodulators such as anti-PD-1, anti-PD-L1, and anti-CTLA-4 Treatment, excluding antiviral treatment; if the patient has used traditional Chinese medicine with anti-tumor indications, it must be > 2 weeks or 5 drug half-lives (whichever is longer). Patients whose adverse events caused by treatment have not recovered to = 2; 6.With other malignant tumors within five years, unless the patient received possible curative treatment and no evidence of the disease within five years, but the time requirements (5 years) is not applicable to have successful removal of skin basal cell carcinoma (BCC), squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ or other patients with carcinoma in situ; 7.Pregnant or breastfeeding women; males or females of childbearing age who are unwilling or unable to take effective contraceptive measures; 8.Known history of alcohol, psychotropic drug or other drug abuse within 6 months before entry into the study; 9.Those the researcher deems inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year cumulative recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival rate;Disease-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhang Lei
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed