Hepatocellular Carcinoma
Conditions
Brief summary
60 patients of radiological, biopsy proven advanced HCC (Hepatocellular carcinoma) patient will be randomized into two groups. Cases group will receive Sorafenib plus vitamin K and control group will receive Sorafenib plus placebo
Interventions
DRUGSorafenib 400mg twice daily + intravenous infusion ofVit K1
Sorafenib 400mg twice daily + intravenous infusion ofVit K1 50 mg/day with daily increase of dose by 50 mg for 6 days, followed by oral Vitamin K1 20mg twice daily for 3month
DRUGSorafenib 400 mg twice daily + Intravenousinfusion of placebo
Sorafenib 400 mg twice daily + Intravenousinfusion ofplacebo daily for 6 days, followed by oral placebo twice daily x 3month
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 70 years * Child A and B cirrhosis with hepatocellular carcinoma * Biochemical, Radiological, histological evidence of advanced hepatocellular carcinoma diagnosed as stage C and stage d with serum bilirubin \<5 mg/dl according to BCLC staging system * HCC with portal vein thrombosis * Unresectable cancer, as assessed carefully by individual experts * No recent active treatment like surgery, radiofrequency ablation, trans arterial chemo embolization, radiotherapy, chemotherapy (within the past 6 months)
Exclusion criteria
* Patients with end-stage hepatocellular carcinoma (Stage D, BCLC)with poor performance status * Child C cirrhosis with HCC (Hepatocellular carcinoma) * HCC with acute decompensated state of CLD - GI bleed, increased jaundice, HE, SBP (Spontaneous Bacterial Peritonitis) * Acute febrile illness * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | 1 Year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria | 3 months | ORR (Objective response rate) as the percentage of randomly assigned patients with complete response or partial response based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria |
| Disease control rate (DCR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria | 3 months | DCR (Disease control rate) as the percentage of randomly assigned patients with complete response, partial response, or stable disease based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria. |
| Biochemical response - improvement in tumor biomarker level | 3 months | — |
| Safety | 1 Years | — |
Countries
India
Outcome results
None listed