Hepatocellular carcinoma
Conditions
Interventions
Experimental group:donafeinib+TACE
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join the group and sign a written informed consent; 2. Aged 18 to 80 years; 3. Subjects with hepatocellular carcinoma diagnosed by clinical diagnosis (refer to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer in China (2019)) or pathologically diagnosed; 4. The subjects are not suitable for radical treatment by liver resection or ablation; 5. The tumor lesions of the subjects are limited to the liver and can be treated with TACE (the maximum diameter of the lesions is = 3 months; 9. Eastern Cooperative Oncology Group (ECOG) physical status (PS) score of 0 to 1; 10. Child-Pugh score=90 g/L; absolute neutrophil count (ANC) >=1.5x10^9/L; platelet count >= 50x10^9/L; (2) Blood biochemical examination (albumin was not used within 14 days before screening): albumin >= 28 g/L; total bilirubin <= 2 ULN; aspartate aminotransferase (AST) , alanine aminotransferase (ALT)<=5 ULN; alkaline phosphatase (ALP)<=5 ULN; Creatinine<=1.5 ULN; (3) Coagulation function: International normalized ratio (INR) or prothrombin time (PT) <=1.5 ULN; activated partial thromboplastin time (APTT) <=1.5 ULN
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed histologically/cytologically containing fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components; 2. A history of malignancy, unless the following criteria are met: (1) The patient has received possible curative treatment and there is no evidence of the disease within 5 years; (2) Skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinomas in situ who have successfully undergone resection; 3. Diffuse tumor lesions; 4. Extrahepatic metastasis or tumor thrombus invading the main portal vein, primary branches of the portal vein, or involving the superior mesenteric vein and inferior vena cava tumor thrombus; 5. Have a history of hepatic encephalopathy, hepatorenal syndrome, or a history of liver transplantation; 6. Pleural effusion, ascites, and pericardial effusion with clinical symptoms requiring drainage; 7. There is central system transfer; 8. A history of serious mental illness; 9. Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.); 10. Received local treatment for liver cancer within the past 4 weeks; 11. Received more than 2 TACE treatments in the past; 12. Received allogeneic stem cell or solid organ transplantation in the past; 13. Previously received targeted therapy against VEGF and/or VEGFR, RAF, MEK and other signaling pathways such as sorafenib, regorafenib, and lenvatinib; 14. Received other anti-tumor systemic therapy in the past, including traditional Chinese medicine with anti-tumor indications, within 2 weeks after the completion of the treatment and before the drug in this study or patients whose adverse events caused by preoperative treatment did not recover to grade 2 ), cardiac arrhythmias that are poorly controlled or require pacemaker therapy, and hypertension that is not controlled by medication (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg); 21. Other significant clinical and laboratory abnormalities that the investigators consider to affect the safety evaluation, such as: uncontrolled diabetes mellitus, chronic kidney disease, periph
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Progression;Overall Survival;Time to Progression to No TACE;Objective Response Rate;Disease Control Rate;Adverse Events and Serious Adverse Events; | — |
Countries
China
Contacts
Public ContactJin Long
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed