Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Sorafenib 400mg twice daily + intravenous infusion ofVit K1; Drug: Sorafenib 400 mg twice daily + Intravenousinfusion of placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02259647

ILBS-HCC-02

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Sorafenib +intravenous infusion ofVit K1

Experimental group

Description:

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

Treatment:

Drug: Sorafenib 400mg twice daily + intravenous infusion ofVit K1

Sorafenib+Placebo

Active Comparator group

Description:

Sorafenib 400 mg twice daily + Intravenousinfusion of placebo daily for 6 days, followed by oral placebo twice daily till 3month

Treatment:

Drug: Sorafenib 400 mg twice daily + Intravenousinfusion of placebo