Hepatocellular carcinoma
Conditions
Interventions
Adjuvant TACE:Adjuvant TACE
Active Surveillance:These patients will receive active Surveillance
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent before the implementation of any trial-related procedures; 2. Male or female: >= 18 years old, 5 cm, multiple tumors, postoperative pathology suggesting microvascular invasion, Vp1/Vp2, postoperative pathology confirming lymph node metastasis, positive or narrow resection margin, and Edmondson grade III-IV of tissue differentiation degree; 7. Transhepatic angiography was performed once 4 to 8 weeks after the operation; 8. Has not received systemic anti-tumor treatment for HCC in the past; 9. Expected survival time >6 months; 10. Have adequate organ and bone marrow functions, and the laboratory test values within 7 days before randomization meet the following requirements (the condition shall not be met by administering any blood components, cell growth factors, albumin or other corrective treatment drugs within 14 days before obtaining the laboratory test). 11. For female participants of childbearing potential, a urine or serum pregnancy test must be conducted within 3 days prior to enrollment, and the result must be negative. If the result of a urine pregnancy test cannot be confirmed as negative, a serum pregnancy test is required. Women not of childbearing potential are defined as those who have been postmenopausal for at least 1 year, or who have undergone surgical sterilization or hysterectomy; 12. If there is a risk of pregnancy, all participants (regardless of gender) must use contraception with a failure rate of less than 1% per year for 120 days after hepatic arterial angiography (or 180 days after the last dose of chemotherapy).
Exclusion criteria
Exclusion criteria: 1. Transhepatic angiography was performed 4 to 8 weeks after the operation, and tumor staining shadows were found in the liver. 2. Previously confirmed histological/cytological components containing fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc. 3. Except for HCC, the subjects had other malignant tumors within 5 years before enrollment. Subjects with other malignant tumors that have been cured through local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, and carcinoma in situ of the cervix or breast; 4. Have a history of hepatic encephalopathy or liver transplantation; 5. Pleural effusion, ascites or pericardial effusion with clinical symptoms that require drainage after HCC surgery; 6. A history of immunodeficiency in the past;Those with positive HIV antibody tests; Currently, systemic corticosteroid hormones or other immunosuppressants are being used for a long time (temporary use of glucocorticoids for treating dyspnea symptoms of chronic obstructive pulmonary disease and other diseases and for preventing allergies is allowed). 7. For subjects who are known to have active pulmonary tuberculosis and are suspected of having it, clinical examinations should be conducted to rule it out. Known active syphilis infection; 8. Severe infection occurs within 4 weeks before the first administration, including but not limited to comorbidities requiring hospitalization, sepsis or severe pneumonia; Active infections that have received systemic anti-infective treatment within two weeks prior to the first administration (excluding antiviral treatment for hepatitis B or hepatitis C). 9. Have received systemic treatment with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for drugs used locally to control pleural effusion or ascites) within 2 weeks before the first administration. 10. Known allergy to any component of any investigational drug; 11. A known history of mental illness, drug abuse, alcohol abuse or drug abuse; 12. Pregnant or lactating women; 13. It may interfere with the test results and hinder the acceptance;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival; | — |
Countries
China
Contacts
Public ContactJian-Hong Zhong
Guangxi Medical University Cancer Hospital
Outcome results
None listed