Hepatocellular carcinoma
Conditions
Interventions
Experimental group:Donafenib combined with TACE
Sponsors
Beijing You'an Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary enrollment, signed written informed consent; 2. Aged 18-80 years (including 80 years), no gender limit; 3. Patients with hepatocellular carcinoma confirmed by clinical diagnosis (refer to the Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2019)) or pathological diagnosis; 4. The patient is not suitable or refuses radical treatment by hepatectomy or ablation; 5. BCLC stage A or B; 6. Number of tumors =3 months; 10. The physical status (PS) score of Eastern Cooperative Oncology Group (ECOG) was 0-1; 11. Child-Pugh score =90g/L; Absolute neutrophil count (ANC) >=1.5x10^9/L; Platelet count >=25x10^9/L; (2) Blood biochemical test (no albumin was used within 14 days before screening) : Albumin >=28g/L; Total bilirubin <=2x upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) <=5xULN; Alkaline phosphatase (ALP)<=5xULN; Creatinine <=1.5 x ULN; (3) Coagulation function: International normalized ratio (INR) or prothrombin time (PT) <=1.5xULN; Activated partial thromboplastin time (APTT) <=1.5xULN.
Exclusion criteria
Exclusion criteria: 1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, and other components previously confirmed by histology/cytology; 2. A history of malignancy unless the following criteria are met: (1) The patient has received potentially curative treatment and has no evidence of the disease within 5 years; (2) Successfully received resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, and other carcinoma in situ; 3. Diffuse neoplastic lesions; 4. Extrahepatic metastasis or tumor thrombus invading the main portal vein, the primary branch of portal vein, or involving the superior mesenteric vein and inferior vena cava tumor thrombus; 5. History of hepatic encephalopathy, hepatorenal syndrome, or liver transplantation; 6. Hydrothorax, ascites and pericardial effusion with clinical symptoms requiring drainage; 7. A history of severe mental illness; 8. Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drugs (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.); 9. Received local treatment for liver cancer within the past 4 weeks; 10. Previous recipients of allogeneic stem cell or parenchymal organ transplantation; 11. Previous systematic therapy, including but not limited to sorafenib, regorafenib, lenvatinib and other anti-VEGF and/or targeted therapy for VEGFR, RAF, MEK and other signaling pathways; Immunomodulators such as tririplimumab, anti-PD-L1, anti-CTLA-4, etc.; 12. Patients who have received other systemic antitumor therapy, including traditional Chinese medicine with antitumor indications, and whose adverse events caused by preoperative treatment did not recover to =140 mmHg and/or diastolic blood pressure >=90 mmHg); 19. Other significant clinical and laboratory abnormalities, such as uncontrolled diabetes mellitus, chronic kidney disease, peripheral neuropathy grade II or higher (CTCAE V5.0), and thyroid dysfunction, were considered to affect the safety evaluation; 20. Severe infections that are active or poorly controlled clinically; 21. Acute or chronic active hepatitis B infection, HBV DNA > 2000IU/ml; 22. Have not recovered from surgery, such as an unhealed incision or severe postoperative complications; 23. Pregnant or lactating patients and fertile patients who are unwilling or unable to use effective contraceptive methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overal Survival (OS);Time to Progression (TTP);Time to Progression to Non-TACE Treatment;Objective Response Rate (ORR);Disease Control Rate (DCR);Safety; | — |
Countries
China
Contacts
Public ContactYuan Chunwang
Beijing You'an Hospital, Capital Medical University
Outcome results
None listed