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Monoclonal Antibodies
Systemic Therapy vs Locoregional Therapy for Liver Cancer (LOST-B Trial)
Phase 2
Recruiting
Led By David Hsieh, MD
Research Sponsored by University of Texas Southwestern Medical 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 baseline until date of death, assessed up to 24 months
Awards & highlights
LOST-B Trial Summary
This trial is comparing two common treatments for hepatocellular carcinoma to see which is more effective and safe.
Who is the study for?
This trial is for adults with intermediate-stage hepatocellular carcinoma (HCC) who haven't had previous cancer treatments. They should have liver-localized tumors not suitable for surgery, no extrahepatic disease or vascular invasion, and be in good physical condition (ECOG 0 or 1). Participants must not have certain infections or be on immunosuppressive drugs, and they need to agree to use contraception.Check my eligibility
What is being tested?
The study compares the effectiveness of atezolizumab/bevacizumab versus locoregional therapies like TACE or TARE in treating HCC. It aims to determine which treatment provides better outcomes for patients who meet specific criteria related to their liver cancer stage and overall health.See study design
What are the potential side effects?
Potential side effects include allergic reactions similar to other antibodies used in treatment, risk of infection due to immune system suppression by the drugs, possible bleeding complications especially if there's a history of varices, and general drug-related risks such as fatigue and digestive issues.
LOST-B Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline until date of death, assessed up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline until date of death, assessed up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
Overall Response Rate
Overall Survival
Time to Deterioration of Liver Function
+2 moreLOST-B Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Atezolizumab and bevacizumabExperimental Treatment1 Intervention
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle. Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
Atezolizumab will be administered first followed by bevacizumab, with a minimum of 5 minutes between dosing.
Group II: Arm B: Locoregional therapy with TACE or TAREActive Control1 Intervention
Patients will undergo locoregional therapy with TACE or TARE per investigator preference.
TACE will be administered every 8 +/- 4 weeks; TARE will be administered every 12 +/- 4 weeks. Proportion of patients being treated with TARE will be capped at 50% of cohort at a protocol level. After 50% cap is reached, patients randomized to Arm B will be treated with TACE.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,595 Total Patients Enrolled
4 Trials studying Liver Cancer
5,606 Patients Enrolled for Liver Cancer
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,695 Total Patients Enrolled
4 Trials studying Liver Cancer
140 Patients Enrolled for Liver Cancer
David Hsieh, MDPrincipal InvestigatorUT Southwestern Medical Center
3 Previous Clinical Trials
95 Total Patients Enrolled
1 Trials studying Liver Cancer
58 Patients Enrolled for Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have high calcium levels in my blood that are causing symptoms.I have recovered from side effects of previous cancer treatments.My liver cancer diagnosis is confirmed by imaging or biopsy.My high blood pressure is not under control.I have received immunotherapy for cancer before.I have a history of bleeding disorders.I have not had surgery or major injuries recently.I have had a stem cell or organ transplant from another person.I have had issues with my brain or nerves.My early-stage cancer was treated successfully with no signs of disease.I have been treated with specific immunotherapy before.I have a wound, ulcer, or bone fracture that is not healing.My liver cancer is of the infiltrative type.I have coughed up blood before.I have not had hepatic encephalopathy in the last 6 months.My liver cancer is of a specific rare type.I have a history of lung problems.I have not received a live vaccine recently.I have had cancer spread to the lining of my brain and spinal cord.I have pain from my cancer that isn't managed well.I have had a minor surgery recently.I am 18 years old or older.I am fully active or can carry out light work.I do not have any uncontrolled illnesses.I have a history of gastrointestinal conditions.I am infected with both hepatitis B and D.I haven't taken any immune-weakening drugs in the last 2 weeks.My liver function is mildly affected.I don't have any health issues that prevent me from taking new medications.My cancer has spread to distant parts of my body or large blood vessels.My organs and bone marrow are working well.I frequently need procedures to remove excess fluid from my chest or abdomen.I haven't had cancer treatment in the last 3 months.I have active tuberculosis.I had an upper endoscopy to check for varices within the last year.I have had significant fluid buildup in my abdomen in the last 6 months.I have or had an autoimmune disease or immune deficiency.I agree to use birth control during and for 6 months after the study.I had skin cancer (not melanoma) treated and currently show no signs of it.I am currently taking or have recently taken specific medications.I have had another type of cancer.I had bleeding from untreated stomach or esophagus veins in the last 6 months.I have not taken any strong antibiotics in the last 2 weeks.My liver cancer cannot be treated with surgery, transplant, or local procedures and has not spread beyond the liver.I have a liver tumor that can be measured over time.I am receiving antiviral therapy for my hepatitis B.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Locoregional therapy with TACE or TARE
- Group 2: Arm A: Atezolizumab and bevacizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Have Atezolizumab and bevacizumab been granted the official sanction of the FDA?
"According to our internal risk assessment, atezolizumab and bevacizumab have a safety score of 2 due to their Phase 2 trial status. There is some evidence supporting the drugs' security but none affirming efficacy."
Answered by AI
Is enrollment currently open for this research project?
"The trial's listing on clinicaltrials.gov suggests that recruitment for this medical study has ceased, as the entry was first posted in January 1st 2023 and last modified on September 16th 2022. Fortunately, there are still 2607 other studies actively searching for participants at present."
Answered by AI
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