Health Condition 1: C220- Liver cell carcinoma
Conditions
Interventions
Intervention1: Sorafenib, Metformin and Atorvastatin: The 1st leg of the study will recruit 10 patients and they will be started on
Sorafenib 400mg BD + Atorvastatin 10mg OD + Metformin 500mg BD
Level
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with advanced HCC, who are not feasible for LDT or have failed LDT 2. Age 18 to 75 years. 3. Barcelona Clinic Liver Classification Category B (if not feasible for LDT) or Category C ECOG performance status 0, 1, 2 5. Child Pugh A and early Child Pugh B (CTP score up to 7) 5. If the patient has been treated with curative intent therapy, this therapy should have been completed at least 6 months prior to enrolment. 6. Patient who can give informed consent for the study. 7. Patient does not have any contraindications to receive Sorafenib 8. Adequate organ function • Hematological- Hb >80 g/L, ANC >= 1.0 x 109/L, platelets >= 60 x 109/L. • Liver functions- bilirubin = 30 g/L. • Renal function- Creatinine 50 mL/min. 9. Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.
Exclusion criteria
Exclusion criteria: 1.Serious co-morbidities such as, but not limited to severe cardiac failure or severe pulmonary compromise or severe and active infections, or uncontrolled hypertension. 2.Previous use of Sorafenib 3.History of hypersensitivity or severe side effects to Atorvastatin and/or Metformin 4.Patients with active second malignancies, apart from skin cancers and cervical intraepithelial neoplasia. The presence of a curatively treated malignancy for which the patient has completed therapy at least 3 years ago and is now in remission for, is considered acceptable. 5.Patients on other investigational drugs within the last 30 days. 6.Patients with BCLC category D 7.Patients with Child Pugh Category C and Child Pugh B (score 8-9) 8.Patients with decompensated cirrhosis, including moderate - severe ascites (degree of ascites based on quantification by USG/CECT/MRI Abdomen and pelvis) 9.Patient with history of liver transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety of combining Sorafenib with Atorvastatin and Metformin 2. Adverse events of combination SAM Timepoint: 30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.EFS 2.PFS 3.Response rates 4.Quality of life Exploratory outcomes Drug levels of Sorafenib in combination with Atorvastatin and Metformin Timepoint: 30 months | — |
Countries
India
Contacts
Public ContactDr Vikas sureshchand Ostwal
Tata Memorial Hospital
Outcome results
None listed