Hepatocellular carcinoma
Conditions
Interventions
Control group:None
Treatment group:Thymosin alpha 1
Sponsors
Kailuan General Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Obtain confirmation from project team members before randomization, meet project requirements and standards, sign informed consent form, and comply with research protocol; 2.Meets the diagnostic criteria of the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition)", and pathological biopsy supports the diagnosis of hepatocellular carcinoma type primary liver cancer; 3.HCC that is assessed as high-risk for recurrence based on the patient's multiple tumors, tumor length>5cm, Edmondson grade III-IV, microvascular or macrovascular invasion, lymph node metastasis, and persistent abnormal postoperative AFP and/or DCP, including those treated with TACE (or TAE) alone or TACE (or TAE) combined with ablation (MWA); 4.For patients with active HBV: During the screening period, HBV DNA= 20 years old and <= 75 years old. 7.Child Pugh A-level status; 8.There is no significant invasion of large blood vessels (coarse vessels) in the portal vein (Vp3 or Vp4) or any level of invasion of large blood vessels in the hepatic vein or inferior vena cava. 9.Expected lifespan of at least 3 months;
Exclusion criteria
Exclusion criteria: 1.History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain Barr é syndrome, or multiple sclerosis; 2.Idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, pulmonary tuberculosis, or history of idiopathic pneumonia, or evidence of active pneumonia on chest CT scan during screening; 3.During the research and treatment period, systemic immunosuppressive drugs (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, etc.) need to be used; 4.Special population with severe cardiovascular and cerebrovascular diseases, upper gastrointestinal bleeding, hepatic encephalopathy, spontaneous peritonitis, diabetes, hyperthyroidism, renal insufficiency, severe infection, intractable hypertension, severe coagulation dysfunction or bleeding tendency. 5.Individuals with active replication of chronic hepatitis B or C virus; 6.Other anti-tumor treatments such as particle implantation, systemic chemotherapy, and radiation therapy have been carried out; 7.Unable to tolerate the treatment plan of this study, poor compliance, or loss to follow-up;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Relapse-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging magnetic resonance imaging was performed, MRI;Chemical examination;Drug safety; | — |
Countries
China
Contacts
Public ContactWang Ying
Kailuan General Hospital
Outcome results
None listed