Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma

Overview

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

Full Title of Study: “Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma – a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 31, 2015

Interventions

  • 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
  • Drug: 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

Arms, Groups and Cohorts

  • Experimental: Sorafenib +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
  • Active Comparator: Sorafenib+Placebo
    • Sorafenib 400 mg twice daily + Intravenousinfusion of placebo daily for 6 days, followed by oral placebo twice daily till 3month

Clinical Trial Outcome Measures

Primary Measures

  • Overall Survival
    • Time Frame: 1 Year

Secondary Measures

  • Objective response rate (ORR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 3 months
  • Safety
    • Time Frame: 1 Years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institute of Liver and Biliary Sciences, India
  • Provider of Information About this Clinical Study
    • Sponsor

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