Unresectable Advanced or Recurrent Hepatocellular Carcinoma
Conditions
Interventions
None listed
Sponsors
Showa University
Division of Cancer Genome and Pharmacotherapy, Department of Clinical Pharmacy, Showa University School of Pharmacy Laboratory of Molecular Pharmacotherapeutics, Faculty of Pharmacy, Kanazawa University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed hepatocellular carcinoma or non-invasively diagnosed according to American Association for the Study of Liver Diseases (AASLD) criteria 2. Patients with unresectable advanced or recurrent disease 3. Patients aged 20 years or older at the time of treatment initiation 4. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 5. Patients with measurable or evaluable lesions 6. Patients with an expected survival of at least 3 months 7. Patients with adequate bone marrow and organ function as assessed by blood tests conducted within 7 days prior to treatment initiation 8. Patients who have provided written informed consent with signature and date prior to enrollment in this study
Exclusion criteria
Exclusion criteria: 1. Patients with severe hepatic dysfunction (Child-Pugh score 10-15) 2. Patients with severe active infection 3. Patients with active double primary cancer 4. Patients deemed difficult to participate in the study due to psychiatric or neurological disorders 5. Pregnant or breastfeeding women, women who may become (or intend to become) pregnant, or men who wish to father children 6. Patients with a history of serious drug hypersensitivity or drug allergy 7. Patients taking medications that affect CYP3A4 (such as phenytoin, carbamazepine, rifampicin, phenobarbital, ketoconazole, macrolide antibiotics, etc.) (eligible if discontinued at least 1 week prior to treatment) 8. Patients with contraindications to lenvatinib 9. Patients judged by the attending physician to be inappropriate for safe conduct of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between lenvatinib pharmacokinetic parameters (AUC, Cmax, T1/2) measured at specified time points (pre-dose, 0.5, 1, 2, 4, 8, 24, 48 hours post-dose, and day 15+/-2) with objective response rate (ORR) at 12 weeks and progression-free survival (PFS) based on RECIST v1.1 criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Association between profiles of genetic polymorphisms identified by exome analysis of pre-treatment tumor tissue or blood samples with treatment response according to RECIST v1.1 criteria at 24 weeks and adverse events (evaluated by CTCAE v5.0) 2. Correlation between temporal changes in soluble MICA concentrations (measured pre-treatment, day 15 +/- 2, and every 4 weeks thereafter) and best overall response determined by imaging assessment 3. Relationship between lenvatinib pharmacokinetic parameters (AUC, Cmax) and incidence of Grade 2 or higher adverse events according to CTCAE v5.0 within 24 weeks of treatment initiation 4. Correlation between overall survival (OS) from treatment initiation to the end of follow-up period (maximum 24 months) and pharmacokinetic parameters | — |
Countries
Japan
Contacts
Public ContactYuki Ichikawa
Division of Gastroenterology, Department of Medicine Division of Gastroenterology, Department of Medicine
Outcome results
None listed