Status:
COMPLETED
Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02259647
Start Date
October 1 2014
End Date
October 31 2015
Last Update
October 28 2019
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070