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

A Prospective Study of HCV-RNA Kinetics During Treatment With Sorafenib in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C

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.

Study Overview

• Status: Terminated
• Conditions: Hepatocellular Cancer
• Intervention / Treatment: Drug: Sorafenib

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: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02214
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Sorafenib taken orally twice per day	Drug: Sorafenib; Other Names: Nexavar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
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.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Andrew Zhu, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: May 6, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (Estimate): May 8, 2013

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Hepatitis C positive
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma, Hepatocellular; Liver Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: 12-213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO