Study Summary
This trial will test whether a combination of two drugs can help treat liver cancer in patients who are eligible for transplantation. The drugs will be given for six months before the transplant procedure.
Eligible Conditions
- Liver Cancer
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 9 Secondary · Reporting Duration: Study enrollment to 1 year after liver transplant, time of liver transplant to 1 year after liver transplant
Month 6
Objective Response Rate
Month 12
Immune Cell Biomarkers
Tumor biomarkers
Year 1
Overall survival after liver transplant
Year 4
Proportion of participants who are removed from the liver transplant waiting list after initiating the atezolizumab/bevacizumab therapy
Proportion of the liver explant tissue containing necrotic tumors
The proportion of participants who proceed to liver transplantation
Year 1
Proportion of Patients Receiving Liver Transplant Experiencing Acute Rejection
Recurrence-free survival in patients receiving a liver transplant
Day 90
Proportion of participants who experience treatment-emergent adverse events
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
1 Treatment Group
Atezolizumab + Bevacizumab
1 of 1
Experimental Treatment
24 Total Participants · 1 Treatment Group
Primary Treatment: Atezolizumab + Bevacizumab · No Placebo Group · Phase 4
Atezolizumab + BevacizumabExperimental Group · 2 Interventions: Bevacizumab, Atezolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2014
Completed Phase 4
~5320
Atezolizumab
2016
Completed Phase 3
~8050
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: study enrollment to 1 year after liver transplant, time of liver transplant to 1 year after liver transplant
Who is running the clinical trial?
The Methodist Hospital Research InstituteLead Sponsor
240 Previous Clinical Trials
35,469 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,502 Previous Clinical Trials
565,138 Total Patients Enrolled
4 Trials studying Liver Cancer
140 Patients Enrolled for Liver Cancer
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are able to receive a TACE procedure.
You have liver cancer that can be measured or evaluated by specific medical criteria called RECIST v1.1 or mRECIST. The cancer cannot be removed by surgery and is not within certain size limits.
You are expected to live for at least 6 more months.
Your body has enough infection-fighting white blood cells, with a count of at least 1.5 x 10^9/L.
You are 18 years or older and have given consent to participate in the study.
You have liver cancer that has not spread beyond the liver. The study requires a small piece of liver tissue to confirm the diagnosis and for research purposes. If you do not consent to a fresh tissue biopsy, previously collected tissue samples may be used.
Your liver is functioning well based on the Child-Pugh score.
You must meet the requirements for liver transplant as described in Section 10.4.
You are in good enough health to perform daily activities without difficulty (ECOG score 0-1).
If you have developed new lesions or the disease has come back in the same place, you can have had previous radiation therapy.
References
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Frequently Asked Questions
Is recruitment open for this research project?
"Clinicaltrials.gov suggests that this research project is not currently recruiting patients, as the trial was most recently updated on January 5th 2022 after being initially posted on March 17th 2022. Although no longer enrolling volunteers for this study, 2739 other clinical trials are actively seeking participants right now." - Anonymous Online Contributor
Unverified Answer
Has the combination of Atezolizumab and Bevacizumab been given the green light by the FDA?
"With Phase 4 trials already conducted and approved, the safety of Atezolizumab + Bevacizumab was deemed a 3 on our team's evaluation scale." - Anonymous Online Contributor
Unverified Answer