Clinical trial · Interventional
Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma
Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma - a Randomized Controlled Trial
NCT02259647CI-TRIAL-00041310completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib 400 mg twice daily + Intravenousinfusion of placebo | Drug | — | UNRESOLVED |
| Sorafenib 400mg twice daily + intravenous infusion ofVit K1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sorafenib +intravenous infusion ofVit K1
- 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
- interventionNames
- Drug: Sorafenib 400mg twice daily + intravenous infusion ofVit K1
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib+Placebo
- description
- Sorafenib 400 mg twice daily + Intravenousinfusion of placebo daily for 6 days, followed by oral placebo twice daily till 3month
- interventionNames
- Drug: Sorafenib 400 mg twice daily + Intravenousinfusion of placebo
Primary outcomes (1)
- measure
- Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.