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

Primary Purpose

Hepatocellular Cancer

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sorafenib
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Cancer focused on measuring Hepatitis C positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Sorafenib taken orally twice per day

Outcomes

Primary Outcome Measures

Decline in HCV-RNA Level
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.

Secondary Outcome Measures

Time to Radiological Tumor Progression
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
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.

Full Information

First Posted
May 6, 2013
Last Updated
March 22, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01849588
Brief Title
HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC)
Official Title
A Prospective Study of HCV-RNA Kinetics During Treatment With Sorafenib in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow Accrual
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Cancer
Keywords
Hepatitis C positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Sorafenib taken orally twice per day
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
Nexavar
Primary Outcome Measure Information:
Title
Decline in HCV-RNA Level
Description
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.
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Time to Radiological Tumor Progression
Description
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.
Time Frame
2 years
Title
Overall Survival
Description
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.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Zhu, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02214
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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