Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259647
• Other study ID #: ILBS-HCC-02
• Status: Completed
• Phase: N/A
• Start date: October 1, 2014
• Est. completion date: October 31, 2015

Study information

• Verified date: October 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2015
• Est. primary completion date: October 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• 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 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

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		1 Year
Secondary	Objective response rate (ORR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria	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	3 months
Secondary	Disease control rate (DCR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria	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.	3 months
Secondary	Biochemical response - improvement in tumor biomarker level		3 months
Secondary	Safety		1 Years