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New treatment option for Hepatocellular Carcinoma
Official title Therasphere® and Systemic Therapy for Patients With Hepatocellular Carcinoma That is High-risk
ClinicalTrials.gov ID: NCT05620771
What this study is testing
What is Y90 + Atezolizumab and Bevacizumab?
Y90 + Atezolizumab and Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research is to compare progression free survival between two available systemic therapies - immunotherapy and tyrosine kinase inhibitors - after Therasphere® (yttrium-90) treatment in adult patients with advanced hepatocellular carcinoma. The immunotherapy consists of a standard-of-care treatment with Atezolizumab and Bevacizumab.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 3.1.1 Patients must have a diagnosis of hepatocellular carcinoma (HCC) confirmed by American Association for Study of Liver Diseases (AASLD)...
- 3.1.2 Patients must have at least 1 lesion that is measurable using RECIST guidelines. NOTE: A previously irradiated lesion can be considered a...
- 3.1.3 Patients may be treatment -naïve or have received any number of prior therapies. NOTE: Prior cancer targeted immunotherapy for any other cancer...
- 3.1.4 Adults ≥18 years old of either gender are eligible.
- 3.1.5 Patients must exhibit an ECOG performance status of 0, 1, or 2 [Appendix 1]
You likely can't join if
- 3.2.1 Patients who are concurrently enrolled in another clinical study unless it is an observational (noninterventional) clinical study or the...
- 3.2.2 Patients who are receiving any other investigational agents within 28 days of registration.
- 3.2.3 Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Y-90, PD-1 \&PD-L1...
- 3.2.4 Patients must not have had prior treatment any PDL1 or PD-1 antagonists.
- 3.2.5 Patients who have known additional malignancy that progressed or required treatment within the last 3 years. Note: Exceptions include...
- 3.2. 6 Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require...
See the full eligibility criteria
Who can join
- 3.1.1 Patients must have a diagnosis of hepatocellular carcinoma (HCC) confirmed by American Association for Study of Liver Diseases (AASLD) guidelines with a Childs-Pugh score of A or B7 [Appendix 5] NOTE: If the...
- 3.1.2 Patients must have at least 1 lesion that is measurable using RECIST guidelines. NOTE: A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable per RECIST, and has...
- 3.1.3 Patients may be treatment -naïve or have received any number of prior therapies. NOTE: Prior cancer targeted immunotherapy for any other cancer is contraindicated and not permitted.
- 3.1.4 Adults ≥18 years old of either gender are eligible.
- 3.1.5 Patients must exhibit an ECOG performance status of 0, 1, or 2 [Appendix 1]
- 3.1.6 Patients must have adequate organ function prior to registration as determined by: Hemoglobin (HgB) ≥ 8.5 g/dL (without the use of growth factors, transfusion permitted), Absolute Neutrophil Count (ANC) ≥ 50 x...
- 3.1.7 Females of childbearing potential (FOCBP), and non-sterilized males who are sexually active must agree to the use of two methods of contraception, with one method being highly effective and the other method being...
- 3.1.8 FOCBP must have a negative pregnancy test (Serum or urine pregnancy test per site investigator discretion) prior to registration.
- 3.1.9 Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.
What rules you out
- 3.2.1 Patients who are concurrently enrolled in another clinical study unless it is an observational (noninterventional) clinical study or the follow-up period of an treatment study.
- 3.2.2 Patients who are receiving any other investigational agents within 28 days of registration.
- 3.2.3 Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Y-90, PD-1 \&PD-L1 antagonists and TKI's. Note: Patients must not have a history of severe...
- 3.2.4 Patients must not have had prior treatment any PDL1 or PD-1 antagonists.
- 3.2.5 Patients who have known additional malignancy that progressed or required treatment within the last 3 years. Note: Exceptions include adequately treated basal cell or squamous cell skin cancer, in situ cervical...
- 3.2. 6 Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic...
- 3.2.7 Patients with renal failure currently requiring dialysis of any kind.
- 3.2.8 Patients with untreated central nervous system (CNS) metastatic disease (including spinal cord and leptomeningeal disease) are excluded. Note: people with previously treated CNS metastases that are...
- 3.2.9 Patients with chronic Hepatitis B with evidence of ongoing viral replication (detectable HBsAg, HBeAg, or HBV DNA). They must have HBV DNA viral load \>100 IU/mL at screening. Note: One viral load is sufficient as...
- 3.2.10 Patients with a known history of Human immunodeficiency virus(HIV) who are not on effective anti-retroviral therapy.
- 3.2.11 Patients with a known history of hepatitis C virus (HCV) infection who have not been treated and cured. Note: For patients with HCV infection who are currently on treatment, they are eligible if they have an...
- 3.2.12 Patients receiving any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment within 28 days of registration. Note: Prior cancer immunotherapy for any other cancer is not permitted. Note...
- 3.2.13 Patients who have unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v 5 [Appendix 6] Grade 0 or 1 with the exception of alopecia and laboratory values listed per the...
- 3.2.14 Patients receiving radiation therapy within 14 days of registration.
- 3.2.15 Patients receiving live vaccines within 28 days of study registration.
- 3.2.16 No systemic glucocorticoids will be permitted within 48 hours prior to study registration. Note: Topical steroids, bronchodilators and local steroid injections are permitted if clinically required.
- 3.2.17 Patients with cardiac disease defined as one of the following are not eligible: Congestive heart failure \> class II NYHA.[Appendix 4], Unstable angina (anginal symptoms at rest) or new onset angina (began within...
- 3.2.18 Patients who have had major surgery within 4 weeks prior to registration.
- 3.2.19 Patients with prior transplant of any kind
- 3.2.20 Patients who are pregnant or nursing.
- 3.2.21 Patients who have an uncontrolled intercurrent illness.
- 3.2.22 Active alcohol use, drug use, or a psychiatric disease that would, in the opinion of the PI or a subinvestigator (sub-I), prevent the subject from complying with the study protocol and/or endanger the subject...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- DeKalb, Illinois, United States
- Geneva, Illinois, United States
- Grayslake, Illinois, United States
- Lake Forest, Illinois, United States
- Orland Park, Illinois, United States
- Warrenville, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; DeKalb, Illinois, United States; Geneva, Illinois, United States; Grayslake, Illinois, United States; Lake Forest, Illinois, United States; Orland Park, Illinois, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.