Patients with Biopsy-proven or radiologically-suggested BCLC A HCC eligible for PA and comprising at least one of the following criteria: - Single tumour>3 cm≤ 5cm or - multiple tumours (max 3 lesions ≤ 3cm) or - Single tumour between 2 and 3 cm with at least one of the following characteristic: • Serum AFP>100 ng/mL • Infiltrative form • Macro-trabecular subtype (if applicable)
Conditions
Brief summary
One-year local recurrence-free survival (potentially compared with historical controls, see references)
Detailed description
- Per nodule assessment of early response (one month) after PA, - Per nodule assessment of local recurrence, - Per nodule assessment of intra segmental distant recurrence, - Per nodule assessment of extra segmental distant recurrence, - Assessment of overall recurrence-free survival at 1 and 2 years, - Evaluation of the safety of lenvatinib administered as neo and adjuvant therapy, - Study of tumour and non-tumour histological/molecular predictors of therapeutic response and resistance based on sequential biopsies performed before and after neo-adjuvant phase then in case of recurrence (if applicable)., - Compliance to lenvatinib treatment, - Consittution of a sequential biobank comprising liver tissue (if applicable) and peripheral samples (serum, plasma)
Interventions
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year local recurrence-free survival (potentially compared with historical controls, see references) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Per nodule assessment of early response (one month) after PA, - Per nodule assessment of local recurrence, - Per nodule assessment of intra segmental distant recurrence, - Per nodule assessment of extra segmental distant recurrence, - Assessment of overall recurrence-free survival at 1 and 2 years, - Evaluation of the safety of lenvatinib administered as neo and adjuvant therapy, - Study of tumour and non-tumour histological/molecular predictors of therapeutic response and resistance based on sequential biopsies performed before and after neo-adjuvant phase then in case of recurrence (if applicable)., - Compliance to lenvatinib treatment, - Consittution of a sequential biobank comprising liver tissue (if applicable) and peripheral samples (serum, plasma) | — |
Countries
France
Outcome results
None listed