The patients with HBV-related hepatocellular carcinoma after radical resection
Conditions
Interventions
teatment group:The treatment period includes the combined intervention treatment period and the maintenance treatment period. After enrollment in the combined intervention treatment phase, subjects wi
Sponsors
Xiamen Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)=18 and =75 years of age, male or female. (2)Subjects with HBV-related hepatocellular carcinoma after radical resection. (3)There is at least one high-risk recurrence factor, including: tumor length =5 cm;; Pathological report showed Microvascular invasion, MVI) or invasion of great vessels; Lymph node metastasis; The number of tumors is =2; Cutting edge = 1 cm; Edmondson-Steiner classification of hepatocellular carcinoma is III or IV. (4)Taked nucleoside (acid) analogues (entecavir 0.5 mg/ tenofovir disoproxil fumarate 300 mg/ propoxytenofovir fumarate 25 mg/ amitenofovir 25 mg, etc.) for antiviral treatment before operation; (5)ECOG PS=2. (6)HBV DNA=500U/mL. (7)Subjects haven't received any systemic treatment for HCC before operation. (8)4-6 weeks after operation, AFP and PIKVII= upper limit of normal value (ULN). (9)4-6 weeks after operation, there is no recurrence in imaging examination. (10)The patient volunteered to participate in the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Subjects with cirrhosis in the decompensated phase, Child-Pugh score B or C, obvious signs of hepatic decompensation such as ascites, hepatic encephalopathy, and ruptured esophagogastric fundic variceal vein bleeding. (2) Diagnosed with malignant tumors of other systems. (3) A history of autoimmune liver disease, alcoholic liver disease, or co-infection with HCV,HDV,HAV, HEV, HIV or tuberculosis. (4) History of severe cardiac disease (e.g., NYHA functional class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia, unstable angina, or other significant cardiovascular disease) (5) Organ transplantation or other serious diseases, or any other circumstances that the PI thinks are not suitable for this study. (6) Allergic to IFN or contraindication: acute severe liver damage: ALT = 10 ULN; Pregnant or lactating patients; clear history of autoimmune diseases; serious history of mental illness; history of severe seizures or are currently using anticonvulsants; history of thyroid disease with poor control after standardized treatment; history of severe retinopathy or clinically relevant ophthalmic diseases; (7) Patients who are allergic to TACE; Have a history of severe allergy to IFN or any monoclonal antibody; Patients with allergic history to nucleoside (acid) analogues; And in addition to the above exclusion criteria, patients who meet any contraindications in the test drug instructions; (8) Patients who are participating in other trials; (9) Unable or unwilling to provide informed consent or follow the requirements of the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| OS;DFS;Time to recurrence, TTR;survival rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free Survival Rate, RFSR; | — |
Countries
China
Contacts
Public ContactZhengyu Yin
Xiamen Hospital of Traditional Chinese Medicine
Outcome results
None listed