NCT02259647

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2015

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

September 11, 2014

Last Update Submit

October 25, 2019

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    1 Year

Secondary Outcomes (4)

  • Objective response rate (ORR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria

    3 months

  • Disease control rate (DCR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria

    3 months

  • Biochemical response - improvement in tumor biomarker level

    3 months

  • Safety

    1 Years

Study Arms (2)

Sorafenib +intravenous infusion ofVit K1

EXPERIMENTAL

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 400mg twice daily + intravenous infusion ofVit K1

Sorafenib+Placebo

ACTIVE COMPARATOR

Sorafenib 400 mg twice daily + Intravenousinfusion of placebo daily for 6 days, followed by oral placebo twice daily till 3month

Drug: Sorafenib 400 mg twice daily + Intravenousinfusion of placebo

Interventions

Sorafenib 400mg twice daily + intravenous infusion ofVit K1DRUG

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 +intravenous infusion ofVit K1
Sorafenib 400 mg twice daily + Intravenousinfusion of placeboDRUG

Sorafenib 400 mg twice daily + Intravenousinfusion ofplacebo daily for 6 days, followed by oral placebo twice daily x 3month

Sorafenib+Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2014

First Posted

October 8, 2014

Study Start

October 1, 2014

Primary Completion

October 31, 2015

Study Completion

October 31, 2015

Last Updated

October 28, 2019

Record last verified: 2019-10

Locations

IN(1)