hepatocellular carcinoma
Conditions
Interventions
Control Group:b-TACE treatment group
Experimental Group:Low-dose lenvatinib in combination with b-TACE treatment group
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily agreed to participate in the clinical trial and provided written informed consent. 2. Aged 18–70 years, with no gender restrictions. 3. Diagnosed with hepatocellular carcinoma (HCC) by histology or cytology, or clinically diagnosed according to AASLD criteria. 4. Tumors assessed by surgeons as surgically unresectable or unlikely to achieve better outcomes with surgery compared to non-surgical treatments. 5. Classified as BCLC stage A or B. 6. Maximum intrahepatic tumor diameter >7 cm. 7. At least one measurable lesion at the site of local treatment (based on mRECIST criteria). 8. Total number of intrahepatic lesions =1.5×10?/L (1500/µL). Hemoglobin >=70 g/L (7.0 g/dL). Platelet count >=50×10?/L (50,000/µL). White blood cell count >=3.0×10?/L (3000/µL). (2) Liver function: Serum albumin >=28 g/L (2.8 g/dL). Total serum bilirubin =50 mL/min (using the Cockcroft-Gault formula). (4) Coagulation function (if not receiving anticoagulation therapy): International normalized ratio (INR) <=2.3. 13. Patients with active hepatitis B virus (HBV) infection: Receiving antiviral therapy according to local treatment standards and willing to continue treatment during the study period. 14. Patients with positive hepatitis C virus (HCV) antibody: Receiving antiviral therapy according to local treatment standards and willing to continue treatment during the study period. 15. Women of childbearing potential: Negative urine HCG test before treatment and agreement to use effective contraception during the study period.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity or intolerance to any drug used in the study. 2. Ablation performed within 6 months or any prior local therapy other than ablation. 3. Uncontrolled clinically significant ascites (unresponsive to diuretics or paracentesis). 4. History of hepatic encephalopathy. 5. Clinically significant gastrointestinal bleeding within 30 days prior to study entry or bleeding due to gastric varices within the past 3 months. 6. Uncorrectable coagulation disorders or significant hematological abnormalities with a high risk of bleeding. 7. Major cardiovascular diseases, including congestive heart failure, New York Heart Association (NYHA) class II or above, unstable angina, myocardial infarction, or arrhythmias requiring medical treatment. 8. History of congenital long QT syndrome or corrected QT interval >480 ms (calculated using the Fridericia method). 9. Left ventricular ejection fraction (LVEF) 150 mmHg and/or diastolic blood pressure >100 mmHg. 11. Urine protein >=1 g in 24 hours (patients with >=1+ proteinuria on urine dipstick should collect a 24-hour urine sample for testing). 12. Prior organ transplantation. 13. Gastrointestinal malabsorption or any other condition that, in the investigator’s opinion, may affect the absorption of the study drug. 14. Pregnancy, breastfeeding, or planning to become pregnant. 15. Active infection, excluding HBV and HCV. 16. History of other malignancies within the past 3 years or concurrent malignancies, excluding completely treated basal cell carcinoma of the skin and in situ cervical cancer. 17. Currently receiving any other investigational drug or experimental medical device. 18. Any other condition that, in the investigator’s opinion, renders the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objective remission rate;Disease control rate;Duration of disease remission;Time to untreatable progression;Time to extrahepatic metastasis;Time to vascular invasion;Surgical resection conversion rate;Surgical resection/ablation conversion rate;Quality of life assessment; | — |
Countries
China
Contacts
Public ContactJinhua Huang
Sun Yat-sen University Cancer Center
Outcome results
None listed