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

JRCT ID: jRCTs061220007

Registered date:13/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 07/07/2022
• Target sample size: 30
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Surgical resection rate after preoperative therapy

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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 < 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 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

Related Information

• Primary Sponsor: Ohdan Hideki
• Source(s) of Monetary Support: Hiroshima Surgical study group of Clinical Oncology (HiSCO)