Hepatocellular Cancer
Conditions
Keywords
Hepatitis C positive
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.
Interventions
DRUGSorafenib
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decline in HCV-RNA Level | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Radiological Tumor Progression | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled between December 2013 and December 2015
Participants by arm
| Arm | Count |
|---|---|
| Sorafenib Sorafenib taken orally twice per day
Sorafenib | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 3 |
Baseline characteristics
| Characteristic | Sorafenib |
|---|---|
| Age, Continuous | 57.8 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
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.
Time frame: up to 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Decline in HCV-RNA Level | 0 Participants |
Secondary
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.
Time frame: 2 years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm | Overall Survival | 8.36 months |
Secondary
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.
Time frame: 2 years
Population: Study was terminated early due to slow accrual.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm | Time to Radiological Tumor Progression | 5.68 months |
Other Pre-specified
Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline
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
Population: AFP levels were not available for one participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline | 0 Participants |