Hepatocellular Carcinoma Hepatocellular Carcinoma
Conditions
Interventions
After the administration of lenvatinib for 8 weeks to patients with initially unresectable hepatocellular carcinoma, the possibility of tumor resection is considered.
Sponsors
Hasegawa Kiyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who had not received systemic chemotherapy for hepatocellular carcinoma 2. Age 20 or older 3. Eastern Cooperative Oncology Group Performance Status(PS) 0-1 4. Adequate organ function WBC count >=3,000/mm3, neutrophil count >=1,500/mm3, hemoglobin >=8.5 g/dL, Platelet count >=75,000/mm3, total bilirubin =2.8 g/dL, AST (GOT), ALP, and ALT (GPT) 40 mL/min (estimated by the Cockcroft-Gault equation) 5. Child-Pugh scores of 5-6 6. Cases without other active malignancies 7. Informed consent (IC) by the person has been obtained with the sufficient explanation on the research participation. 8. The tumor condition of hepatocellular carcinoma must be judged to be unresectable at the time of enrollment at the discretion of each medical institution. The status is classified as A, B, C, D, and E below.*1 A) [Intrahepatic vascular invasion] Intrahepatic tumors are classified as Vv2-3, Vp2-4, and B2-4.No extrahepatic tumor. *2 B) [Synchronous extrahepatic metastases] Intrahepatic tumors are resectable without gross vascular invasion. Extrahepatic disease, including distant organ metastasis, peritoneal metastasis, lymph node metastasis, and tumor dissemination along the route of puncture. *3 C) [Intrahepatic vascular invasion and synchronous extrahepatic metastasis] Intrahepatic tumor is Vv2-3, Vp2-4, and B2-4*2, diagnosed as synchronous extrahepatic metastasis*3. D) [Macroscopic residual tumor] When all intrahepatic tumor resections are difficult but therapeutically meaningful surgical resection is performed*4. E) [Metachronous extrahepatic metastases] No intrahepatic tumor is present or is controllable. A diagnosis of extrahepatic metastasis*5. *1 The tumor conditions of A to E have poor prognosis and oncologically unresectable. It is also classified as unresectable according to the BCLC guidelines frequently used worldwide. However, since there are no other effective therapies, the resection has always been performed at the high volume centers in Japan. *2 Caution should be exercised with respect to the appearance of symptoms associated with tumor necrosis in patients with Vp4 tumors and 50% or more tumor-liver occupancy, which had been excluded from the REFLECT study. *3 Limited to single organ metastases. Adrenal: No bilateral metastases. Lymph node metastasis is confined to the case of intraperitoneal metastasis. The upper limit of the number of tumors is five pulmonary metastases, two lymph node metastases, five peritoneal metastases, one bone metastases and one puncture route recurrence. When the diagnosis of extrahepatic metastasis is difficult, the examination which seems to be necessary such as PET is carried out, and the eligibility of the research is comprehensively judged in each medical institution. *4 Improvement in survival benefit or quality of life is expected. *5 Patients with bone metastases are excluded, except that they are similar to *3.
Exclusion criteria
Exclusion criteria: 1. Refractory pleural or ascitic effusions 2. When a qualitative test for proteinuria shows a result of 2+ or more, or when a quantitative test of a 24-hour urine sample shows urinary protein excretion of 1 g or more 3. Have complications of hepatic encephalopathy 4. Serious complications such as Uncontrolled hypertension despite appropriate antihypertensive treatment, Heart failure, angina or arrhythmias, acute MI within 6 months, Complicated malignancies, serious psychiatric illness within 3 years, Allergic Reactions to Contrast Agents Preventing Angiography* 5. Haemorrhagic or thrombotic disease or history of GI bleeding or active hemoptysis 6. Pregnant or lactating women, women of childbearing age (if effective contraception is not used) 7. When ingestion is difficult 8. With brain or meningeal metastases 9. There are active infections except hepatitis virus infection. 10. HIV-positive cases 11. Cases with pulmonary fibrosis or interstitial pneumonia 12. Patients who received blood transfusions or received G-CSF products within 14 days before enrollment 13. Poor performance status determined by the attending physician as inappropriate for participation in the study * When neither contrast-enhanced CT nor contrast-enhanced MRI is possible (if either is possible, it can be registered)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Macroscopic curative resection rate 2. Overall survival(OS) 3. Overall response rate (ORR) 4. Progression-free survival (PFS) 5. ICGR15 after chemotherapy 6.Surgical resection rate with effective protocol treatments | — |
Contacts
Public ContactAkihiko Ichida
The University of Tokyo Hospital
Outcome results
None listed