Hepatocellular CarcinomaNCT02259647
Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma
A study testing Sorafenib 400mg twice daily + intravenous infusion ofVit K1 in people with Hepatocellular Carcinoma, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sorafenib 400mg twice daily + intravenous infusion ofVit K1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2014to 31 Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma - a Randomized Controlled Trial
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
- Hepatocellular Carcinoma
- Being tested
- Sorafenib 400mg twice daily + intravenous infusion ofVit K1, Sorafenib 400 mg twice daily + Intravenousinfusion of placebo
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Sorafenib 400 mg twice daily + Intravenousinfusion of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 1 Year
Secondary outcomes (4)
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
Measured: 3 months
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.
Measured: 3 months
Biochemical response - improvement in tumor biomarker level
Measured: 3 months
Safety
Measured: 1 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study start1 Oct 2014
- Primary completion31 Oct 2015
- Study completion31 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259647
- Sponsor's protocol ID
- ILBS-HCC-02
- Status last verified
- Oct 2019
- First submitted
- 11 Sep 2014
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02259647
- Acronym / sponsor ID
- ILBS-HCC-02
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 31 Oct 2015 (actual)
- Study completion
- 31 Oct 2015 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sorafenib +intravenous infusion ofVit K1 | Experimental | Drug: Sorafenib 400mg twice daily + intravenous infusion ofVit K1Sorafenib 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+Placebo | Active comparator | Drug: Sorafenib 400 mg twice daily + Intravenousinfusion of placeboSorafenib 400 mg twice daily + Intravenousinfusion of placebo daily for 6 days, followed by oral placebo twice daily till 3month |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorafenib 400mg twice daily + intravenous infusion ofVit K1Sorafenib 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 +intravenous infusion ofVit K1 |
| Sorafenib 400 mg twice daily + Intravenousinfusion of placeboSorafenib 400 mg twice daily + Intravenousinfusion ofplacebo daily for 6 days, followed by oral placebo twice daily x 3month | Drug | Sorafenib+Placebo |
Primary outcome
Overall Survival
Time frame: 1 Year
4 secondary outcomes
Objective response rate (ORR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria
Time frame: 3 months
Disease control rate (DCR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria
Time frame: 3 months
Biochemical response - improvement in tumor biomarker level
Time frame: 3 months
Safety
Time frame: 1 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sorafenib 400mg twice daily + intravenous infusion ofVit K1 in people with Hepatocellular Carcinoma, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.