Clinical trial NCT01849588: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatocellular Cancer
Keywords: Hepatitis C positive
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Decline in HCV-RNA Level
timeFrame: up to 2 years
Secondary outcomes:
measure: Time to Radiological Tumor Progression
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
measure: Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline
timeFrame: 2 years
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Andrew Zhu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: