Efficacy and safety of liver resection after preoperative therapy for intermediate stage hepatocellular carcinoma unsuitable for resectio
- Conditions
- Hepatocellular carcinomaHepatocellular carcinoma, intermediate stage
- Registration Number
- JPRN-jRCTs061220007
- Lead Sponsor
- Ohdan Hideki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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 < 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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Surgical resection rate after preoperative therapy
- Secondary Outcome Measures
Name Time Method 1. Objective response rate (ORR)<br>2. Relapse-free survival (RFS)<br>3. Overall survival (OS)<br>4. Macroscopic curative resection rate<br>5. Response predictive factor of Lenvatinib and TA<br>CE sequential therapy<br>6. Changes in liver function before and after lenvatinib and TACE sequential therapy<br>7. Safety