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HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01849588
Recruitment Status : Terminated (Slow Accrual)
First Posted : May 8, 2013
Results First Posted : March 13, 2017
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Andrew X. Zhu, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE May 6, 2013
First Posted Date  ICMJE May 8, 2013
Results First Submitted Date  ICMJE January 23, 2017
Results First Posted Date  ICMJE March 13, 2017
Last Update Posted Date April 19, 2017
Study Start Date  ICMJE May 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
Decline in HCV-RNA Level [ Time Frame: up to 2 years ]
Successful decline in HCV (hepatitis C virus)-RNA level, with success defined as a decrease of at least two logs of HCV-RNA between baseline and any subsequent measurement.
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
Change in HCV-RNA Level [ Time Frame: 2 years ]
Change in HCV-RNA level more than in 2 logs during treatment with sorafenib
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • Time to Radiological Tumor Progression [ Time Frame: 2 years ]
    Time to radiological tumor progression is defined as the time period between enrollment and the earlier of tumor progression and death. Participants who are alive and progression-free at the date of last contact will be censored at this date.
  • Overall Survival [ Time Frame: 2 years ]
    Overall survival is defined as the time period between enrollment and the date of death. Participants who are still alive at last contact will be censored at this date.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
  • Time to Radiological Tumor Progression [ Time Frame: 2 years ]
    Time to radiological tumor progression
  • Overall Survival [ Time Frame: 2 years ]
    Overall survival
Current Other Pre-specified Outcome Measures
 (submitted: January 23, 2017)
Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline [ Time Frame: 2 years ]
The proportion of participants with a decrease of greater than 20% in AFP (alpha-fetoprotein) level between baseline and any subsequent measurement following treatment with sorafenib will be reported.
Original Other Pre-specified Outcome Measures
 (submitted: May 7, 2013)
Decrease AFP level > 20% from the baseline [ Time Frame: 2 years ]
Decrease AFP level > 20% from the baseline during treatment with sorafenib
 
Descriptive Information
Brief Title  ICMJE HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC)
Official Title  ICMJE A Prospective Study of HCV-RNA Kinetics During Treatment With Sorafenib in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C
Brief Summary

This research study is a Phase IV clinical trial. Phase IV trials are used to further test and monitor the safety of a drug approved by the FDA and to see if the drug has any other indications that can be used to treat different diseases.

Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of liver cancer. It is also currently being tested in various other cancers. Sorafenib works by slowing down and/or stopping the development of new cancer cells and new blood vessels. By slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents or slows down the growth of tumors.

The researchers of this study would like to study the effects of sorafenib on hepatitis C by drawing additional research blood samples from people infected with hepatitis C who are receiving sorafenib treatment for liver cancer. These tests will measure certain proteins in the blood (HCV-RNA) which may indicate if sorafenib has any effect on the hepatitis C virus.

Detailed Description

This is a prospective, open-label, non-interventional trial to evaluate HCV-RNA levels during treatment with Sorafenib in patients with advanced hepatocellular carcinoma.

Participants will receive Sorafenib 400mg orally twice daily. HCV-RNA (Hepatitis C Virus - Ribonucleic Acid) levels will be measured at baseline, week 2 of sorafenib, week 4 of sorafenib, week 6 of sorafenib, week 8 of sorafenib, week 12 of sorafenib, and 2 weeks after discontinuing sorafenib. HCV-RNA levels will be measured by drawing about 2 tablespoons of blood

During the study period, tumor assessments will be done by MRI (magnetic resonance imaging) or CT (computed tomography) scans at baseline and every 8 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Cancer
Intervention  ICMJE Drug: Sorafenib
Other Name: Nexavar
Study Arms  ICMJE Experimental: Treatment Arm
Sorafenib taken orally twice per day
Intervention: Drug: Sorafenib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 23, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2013)
20
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically and/or radiologically confirmed advanced HCC
  • Detectable HCV RNA with anti-HCV-positivity
  • Life expectancy of at least 3 months
  • Willing to use adequate contraception

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Undetectable HCV RNA
  • Uncontrolled hypertension
  • Active or clinically significant cardiac disease
  • Thrombolic, embolic, venous or arterial events within 6 months of informed consent
  • Pulmonary hemorrhage/bleeding event (NCI-CTCAE grade 2 or higher) within 4 weeks before study entry
  • Previously untreated or concurrent cancer except cervical cancer in situ, treated basal cell carcinoma or superficial bladder tumor
  • Presence of non-healing wound, ulcer or bone fracture
  • History of organ allograft
  • Known or suspected allergy or hypersensitivity to any of the study drugs
  • Any malabsorption condition
  • Inability to comply with the protocol and/or not willing or not available for follow up
  • Major surgery within 30 days prior to start of study drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01849588
Other Study ID Numbers  ICMJE 12-213
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andrew X. Zhu, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Zhu, MD, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP