Efficacy and safety of liver resection after Lenvatinib - transcatheter arterial chemoembolization sequential therapy for intermediate stage hepatocellular carcinoma unsuitable for resection

Ohdan Hideki0 个研究点目标入组 30 人开始时间: 2022年4月13日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•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

发起方

Ohdan Hideki