hepatocellular carcinoma
Conditions
Interventions
Donafenib group:None
Donafenib+PD-1/L1 Group:None
Donafenib+TACE Group:None
Sponsors
The First Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. 18 - 70 years old, gender not restricted; 2. Received radical resection for liver cancer 4 - 8 weeks before enrollment; 3. Had high-risk recurrence factors and met any of the following criteria: tumor diameter > 5 cm / pathological indication of MVI positive / multiple lesions (> 3) / Edmondson III-IV grade / preoperative alpha-fetoprotein > 400 ng/ml / accompanied by satellite lesions / tumor rupture and bleeding / incomplete tumor capsule / resection margin < 1 cm; 4. Liver function classification: Child-Pugh grade A; 5. ECOG PS score: 0 - 1; 6. Postoperative imaging and laboratory examinations did not indicate recurrence or metastasis; 7. Have sufficient organ functional reserve; 8. The patient voluntarily enrolled, was able to provide written informed consent, and could understand and follow the trial protocol for medication, follow-up.
Exclusion criteria
Exclusion criteria: 1. Positive margin; 2. Received other adjuvant treatments (except antiviral therapy) after surgery, including local supportive treatments; 3. Preoperative presence of portal vein invasion, inferior vena cava tumor thrombus, hepatic vein tumor thrombus or bile duct tumor thrombus, lymph node invasion or extrahepatic metastasis; 4. The patient has a known or suspected history of allergy to tyrosine kinase inhibitor (TKI) drugs, or is allergic to the excipients of the study drug; 5. There is uncontrollable hepatic encephalopathy, liver-kidney syndrome, ascites, pleural effusion or pericardial effusion; 6. Active bleeding or abnormal coagulation function, with a bleeding tendency or undergoing thrombolytic, anticoagulant or antiplatelet treatment; 7. A history of gastrointestinal bleeding in the past 4 weeks or a clear tendency of gastrointestinal bleeding (such as known local active ulcer lesions, fecal occult blood ++ or above, if persistent fecal occult blood +, a gastroscopy should be performed), or other conditions that the investigator deems likely to cause gastrointestinal bleeding (such as severe gastric fundus/esophageal varices); 8. Gastrointestinal perforation, abdominal fistula or abdominal abscess occurred within the past 6 months; 9. Pregnant or lactating women, as well as women or men patients who are unwilling or unable to take effective contraceptive measures; 10. Other reasons deemed by the investigator as not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One Year Recurrence Free Survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence Free Survival;Overall Survival;Time To Recurrence;Alpha Fetoprotein; | — |
Countries
China
Contacts
Public ContactYong Ma
The First Affiliated Hospital of Harbin Medical University
Outcome results
None listed