Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2015-10-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Niacinamide; Sorafenib; Vitamin K; Vitamin K 1; Vitamins

Criteria

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