Your session is about to expire
← Back to Search
Monoclonal Antibodies
Immunotherapy + Antiviral Therapy for Liver Cancer and Hepatitis C
Phase 4
Recruiting
Led By Harrys A. Torres, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 2 years.
Awards & highlights
Study Summary
This trial tests if a combo of drugs can help to control liver cancer and hepatitis C.
Who is the study for?
Adults with advanced liver cancer (HCC) and chronic Hepatitis C who haven't had systemic therapy for HCC, have a life expectancy over 3 months, and can't be cured by surgery or local therapies. They must have detectable Hepatitis C virus RNA, acceptable organ function, no history of certain other diseases or conditions that could interfere with the trial, not be pregnant or breastfeeding, and agree to use contraception.Check my eligibility
What is being tested?
The study is testing if combining immune checkpoint therapy (atezolizumab) with bevacizumab alongside direct-acting antiviral drugs improves control of liver cancer and Hepatitis C in patients. It's seeing if this approach works better than current treatments.See study design
What are the potential side effects?
Possible side effects include high blood pressure from bevacizumab; fatigue, nausea from atezolizumab; headache and tiredness from sofosbuvir/velpatasvir/voxilaprevir; anemia from ribavirin. Side effects vary per person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: DAA therapy plus Bevacizumb and AtezolizumabExperimental Treatment6 Interventions
Participants will receive bevacizumab and atezolizumab about every 3 weeks as part of the standard of care HCC treatment that is managed by your cancer doctor. In addition, Participants will continue receiving your standard of care DAAs (either sofosbuvir + velpatasvir or sofosbuvir + velpatasvir + voxilaprevir)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sofosbuvir
2014
Completed Phase 4
~2640
Voxilaprevir
2014
Completed Phase 1
~160
Ribavirin
2010
Completed Phase 3
~3250
Bevacizumab
2013
Completed Phase 4
~5280
Atezolizumab
2017
Completed Phase 3
~5860
Velpatasvir
2014
Completed Phase 1
~1250
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,459 Total Patients Enrolled
21 Trials studying Liver Cancer
9,396 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,426 Total Patients Enrolled
103 Trials studying Liver Cancer
26,653 Patients Enrolled for Liver Cancer
Harrys A. Torres, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
1 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My test shows I have hepatitis C virus in my blood.I am 18 years old or older.I am currently being treated for an infection.I am a woman who can have children and have a recent negative pregnancy test.I do not have fluid in my abdomen, brain swelling, or untreated blood vessel issues.I have had an organ or bone marrow transplant.My liver cancer has spread to major blood vessels or the heart.I have had bleeding from varices in my esophagus or stomach in the past 6 months.I am a man who can father children and agree to use birth control as required.I have a history of chronic hepatitis not caused by HCV.I had another cancer but have been free of it for 5 years after treatment.My liver is functioning well according to the Child-Pugh A score.I do not have a history of serious or unstable heart disease.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.I had liver surgery or treatment targeting the liver area within the last 6 weeks.I have had or currently have lung inflammation treated with steroids.I have active hepatitis B that hasn't been treated.My liver cancer diagnosis is confirmed but not fibrolamellar or mixed type.I have chronic hepatitis C with any genotype.I have not had any drug treatments for liver cancer.I have been treated with specific immune therapy for cancer.I have experienced brain function issues in the past 6 months.I have not received a live vaccine in the last 30 days.I have not received a live vaccine in the last 30 days.I am fully active or can carry out light work.My condition cannot be cured with surgery or localized treatments.I had hepatitis B in the past, but now I don't have the virus according to my tests.I have had treatments for liver cancer, but not including sorafenib or regorafenib.I have an active tuberculosis infection.I have been diagnosed with HIV.My liver disease has been staged.I have been treated for an autoimmune disease in the last 2 years.I started my first cancer treatment less than 14 days ago.
Research Study Groups:
This trial has the following groups:- Group 1: DAA therapy plus Bevacizumb and Atezolizumab
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the combination of DAA therapy alongside Bevacizumb and Atezolizumab sanctioned by the Federal Drug Administration?
"There is already approval for DAA therapy, Bevacizumb and Atezolizumab as a treatment option so it received the highest score of 3."
Answered by AI
Is enrollment for this investigation still available?
"According to clinicaltrials.gov, this particular trial has concluded its recruitment process and is no longer accepting new participants. The study began in July of 2021 but was last updated on January 27th 2023. Fortunately, 863 other trials are still actively recruiting patients at the present time."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger