Atezolizumab and Bevacizumab Before Surgery for the Treatment of Resectable Liver Cancer (NCT04721132) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Atezolizumab and Bevacizumab Before Surgery for the Treatment of Resectable Liver Cancer
United States16 participantsStarted 2021-02-10
Plain-language summary
This phase II trial studies the effect of atezolizumab and bevacizumab before surgery in treating patients with liver cancer that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving the combination of atezolizumab and bevacizumab may help to prevent liver cancer from returning after surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must provide written informed consent prior to initiating any trial related procedures.
. Patient must be ≥ 18 years of age
. Patient has histologically confirmed (if tumor tissue is unavailable, documentation of diagnosis from original biopsy is acceptable) or clinically diagnosed (American Association for the Study of Liver Disease criteria in cirrhotic subjects) hepatocellular carcinoma (HCC).
. Patient has resectable disease with no evidence of extrahepatic spread. The determination of resectability status will ultimately lie in the clinical judgment of the surgical oncologist and medical oncologist involved in the care of the patient.
. Must have a Child-Turcotte-Pugh score of A
. Patients must have at least one measurable site of disease per RECIST version 1.1(Appendix 4) or Immune- Modified RECIST. This is defined as a lesion that can be accurately measured in at least one dimension and measures a minimum of ≥ 10 mm (longest diameter to be recorded) with US, MRI or Spiral CT.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patient has record of treated (as necessary per local SoC guidelines) or absent esophageal varices by esophagogastroduodenoscopy within 6 months of initiating treatment.
. Patient must be willing to undergopretreatment research biopsy to provide a tumor sample for exploratory biomarker research.
Exclusion criteria
. Patient has been treated for this malignancy, has another active malignancy, or has had an active malignancy within the last two years.
. Patient has fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
. Patient has had a bleeding event due to untreated esophageal and/or gastric varices.
. Patient has history of abdominal or tracheoesophageal fistula, GI perforation, or intra- abdominal abscess within 6 months of initiation of study treatment.
. Patient has history of thrombosis, bleeding diathesis, History of Grade ≥ 4 venous thromboembolism, coagulopathy or significant vascular disease, serious, non-healing wound, active ulcer, or untreated bone fracture
. Current or recent (\< 10 days prior to initiation of study treatment) use of aspirin (\> 325 mg/day), or clopidogrel (\> 75 mg/day) Note: The use of full-dose oral or parenteral anticoagulants for therapeutic purpose is permitted as long as the INR and/or aPTT is within therapeutic limits (according to institution standards) within 7 days prior to initiation of study treatment and the patient has been on a stable dose of anticoagulants for ≥ 2 weeks prior to initiation of study treatment. Prophylactic use of anticoagulants is allowed. However, the use of direct oral anticoagulant therapies such as dabigatran (Pradaxa) and rivaroxaban (Xarelto) is not recommended due to bleeding risk
. Patient has history of hemoptysis within 30 days of initiation of study treatment.
. Patient has serious cardiac disease, such as New York Heart association Grade II or greater congestive heart failure, MI, unstable angina, etc.