Health Condition 1: K769- Liver disease, unspecified
Conditions
Interventions
Intervention1: Lenvatinib and Mebendazole: Lenvatinib
Dose:8 mg if body weight is less than 60 kg and 12 mg if body weight is more than 60 kg
frequency:once a day
route of administration: oral
dura
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1) Cirrhosis of Liver with HCC on imaging and/or biopsy or cytology 2) Child Pugh A, Child Pugh B 3) Advanced HCC - as defined by BCLC - C 4) ECOG Performance Status 1-2 5) Adequately controlled blood pressure (BP) with up to 3 antihypertensive agents, defined as BP 6) Valid Consent 7) Age 18-70 years
Exclusion criteria
Exclusion criteria: 1) Decompensated Cirrhosis 2) Child Pugh C, Child Pugh B > 7 3) HCC patients with a curative therapy (RFA/MWA or LT) 4) Prior systemic therapies (or) immunotherapy for HCC 5) ECOG Performance Status 3-4 6) Post Liver transplant HCC recurrence 7) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Overall survival in both groups 2) Death 3) Progressive disease requiring change of therapy in both groups.Timepoint: 15 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Decompensation of underlying cirrhosis in both groupsTimepoint: 2 year;Progressive disease requiring quitting therapy in both groupsTimepoint: 2 year;Therapy related adverse effects in both groupsTimepoint: 2 year;Worsening of performance status in both groupsTimepoint: 2 year | — |
Countries
India
Contacts
Public ContactDr Ashok Choudhary
Institute of Liver and Biliary Sciences
Outcome results
None listed