Hepatocellular carcinoma Hepatocellular carcinoma, intermediate stage
Conditions
Interventions
Patients with unresectable intermediate stage hepatocellular carcinoma will be treated with Lenvatinib for 4 weeks followed by TACE. After TACE, administer Lenvatnib for 4 weeks again. Surgical resect
Lenvatinib, TACE, Liver resection
Sponsors
Ohdan Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 20 years or older at the time of obtaining informed consent 2. No history of systemic chemotherapy for hepatocellular carcinoma 3. Eastern cooperative Oncology Group Performance Status (PS) 0-1 4. Child-Pugh score of 5-6 5. Adequate organ function: White blood cell count > 3000/mm3 Neutrophil count > 1500/mm3 Hemoglobin level > 8.5g/dL Platelet count > 75000/mm3 Total bilirubin level > 2.0mg/dL Serum albumin level > 2.8g/dL AST, ALT 40mL/min Proteinuria > 2+ 6. No other active malignant disease 7. Documented consent for participation in this study 8. Classified as intermediate stage by BCLC classification 9. Outside the Up-to-7 criteria 10. Patients who have been treated with TACE up to once (At last 4 months have passed since the last TACE. However, more than 4 months must have passed since the last TACE, and TACE used in combination with curative therapy is not counted.) 11. Patients who have not undergone lobectomy or hepatectomy. 12. Less than 10 tumors.
Exclusion criteria
Exclusion criteria: 1. Refractory pleural effusion or ascites 2. Hepatic encephalopathy 3. Serious complications such as the following Seizures and paroxysmal disease, NYHA class II or higher congestive heart failure, serious psychiatric illness, allergic reaction to contrast media that interferes with angiography, uncontrolled hypertension, active bleeding 4. History of cardiovascular disease and thromboembolism within 6 months prior to enrollment, or arrhythmia requiring treatment 5. Pregnant or lactating women, women who may be pregnant, or women who hope to have a baby. 6. Difficulty in oral intake 7. Active infections other than hepatitis virus infection 8. HIV positive 9. Pulmonary fibrosis or interstitial pneumonia 10. Blood transfusion or administration of G-CSF within 14 days prior to enrollment 11. Patients whose general condition is judged by the attending physician to be ineligible for participation in the study 12. Patients who cannot undergo contrast-enhanced CT or contrast-enhanced MRI 13. Patients who are participating or intend to participate in other clinical studies while participating in this study 14. Cases that are judged to interfere with, limit, or confuse the specific evaluation to the clinical research protocol 15. Any person employed by the principal investigator who is directly involved in this or other clinical research, or an employee of the implementing medical institution
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical resection rate after preoperative therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective response rate (ORR) 2. Relapse-free survival (RFS) 3. Overall survival (OS) 4. Macroscopic curative resection rate 5. Response predictive factor of Lenvatinib and TA CE sequential therapy 6. Changes in liver function before and after lenvatinib and TACE sequential therapy 7. Safety | — |
Contacts
Public ContactTsuyoshi Kobayashi
Hiroshima university hospital
Outcome results
None listed