NIPH Clinical Trials Search

JRCT ID: jRCTs061220007

Registered date:13/04/2022

Efficacy and safety of liver resection after preoperative therapy fo r intermediate stage hepatocellular carcinoma unsuitable for resection

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHepatocellular carcinoma
Date of first enrollment07/07/2022
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)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 resection is performed in cases judgged to be curatively r esectable after imaging evaluation. For cases that do not be met " Criteria for surgical resection", treatment other than surgery should be continued.


Primary OutcomeSurgical resection rate after preoperative therapy
Secondary Outcome1. 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

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1. 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 < 5 x upper limit of each medical institution Creatinine clearance > 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.
Exclude criteria1. 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

Related Information


Public contact
Name Tsuyoshi Kobayashi
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima Hiroshima Japan 734-8551
Telephone +81-82-257-5222
Affiliation Hiroshima university hospital
Scientific contact
Name Hideki Ohdan
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima Hiroshima Japan 734-8551
Telephone +81-82-257-5222
Affiliation Hiroshima university hospital