Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Sorafenib 400mg twice daily + intravenous infusion ofVit K1; Drug: Sorafenib 400 mg twice daily + Intravenousinfusion of placebo

• Registration Number: NCT02259647
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-11
• Study Start: 2014-10-01
• Study First Submitted QC: 2014-10-04
• Study First Posted: 2014-10-08
• Primary Completion: 2015-10-31
• Study Completion: 2015-10-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sorafenib +intravenous infusion ofVit K1	Sorafenib 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
Sorafenib+Placebo	Sorafenib 400 mg twice daily + Intravenousinfusion of placebo	Sorafenib 400 mg twice daily + Intravenousinfusion of placebo daily for 6 days, followed by oral placebo twice daily till 3month

Primary Outcome Measures

Name	Time	Method
Overall Survival	1 Year

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India