hepatocellular carcinoma
Conditions
Interventions
Experimental Arm:transcatheter arterial chemoembolization
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old = age = 80 years old, no gender limit; 2. Primary liver cancer that strictly meets the clinical diagnostic standards of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)" or is diagnosed by pathological histology or cytology; 3. CNLC stage IIb~IIIa patients and stage Ib-IIa patients who cannot tolerate or refuse surgery. 4. Expected survival = 3 months; 5. Child-Pugh liver function rating A or B (7~8 points); 6. ECOG-PS score 0-1; 7. The diameter of a single tumor is 3-7cm, or the sum of the diameters of multiple tumors is <10 cm; 8. If the patient is HBV antigen-positive, receive routine antiviral treatment; 9. If the patient has previously undergone radical surgical resection or ablation treatment, the target lesion recurs or new lesions appear after 2 years; 10. Subjects voluntarily participated in this study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe liver dysfunction, including severe jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome; 2. Uncorrectable coagulation disorder; 3. Combined with serious infections that cannot be effectively controlled; 4. Diffuse liver cancer; 5. Liver cancer patients with hepatic artery-portal vein fistula or inferior vena cava fistula; 6. Accompanied by other malignant tumors, except basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, breast intraductal carcinoma in situ and papillary thyroid carcinoma that have been cured with local treatment; 7. Known to be allergic to TACE or study drugs and any excipients; 8. The target lesion has been treated with DEB-TACE in the past; 9. Currently participating in other research treatments; or those who have participated in any other drug or device clinical trials within 1 month; 10. Combined with autoimmune diseases, or have a history of autoimmune diseases and are expected to relapse; 11. Major organ failure, such as compensated cardiopulmonary and renal failure; severe renal dysfunction; 12. Patients with poor compliance such as migrants; 13. Pregnant or lactating women and patients with childbearing potential who are unwilling or unable to take effective contraceptive measures; 14. Have a clear history of neurological or mental disorders, including epilepsy and dementia; known history of psychotropic drug abuse or drug abuse; 15. Patients who are not suitable for participation in this study in the opinion of the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;6-month progression free survival rate;Safety; | — |
Countries
China
Contacts
Public ContactZhiping Yan
Zhongshan Hospital, Fudan University
Outcome results
None listed