Evaluating a combination of treatments for liver cancer
Phase II Single-Arm Study of Durvalumab and Bevacizumab Following Transarterial Radioembolization Using Yttrium-90 Glass Microspheres (TheraSphere™) in Unresectable Hepatocellular Carcinoma Amenable to Locoregional Therapy
This study is testing a new combination of treatments for liver cancer to see if it can help people whose cancer can’t be removed by surgery and who haven’t responded to other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 130 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | durvalumab, bevacizumab |
| Locations | 25 sites (Aurora, Colorado and 24 other locations) |
| Trial ID | NCT06040099 on ClinicalTrials.gov |
What this trial studies
This Phase II interventional study aims to assess the efficacy and safety of combining durvalumab and bevacizumab therapies with transarterial radioembolization (TARE) in patients with unresectable hepatocellular carcinoma (HCC) who are eligible for embolization. The study will enroll approximately 125 participants across 20 sites in the US, focusing on those who have not responded to or are ineligible for curative treatments like surgery or transplantation. Participants must meet specific criteria regarding liver function and disease characteristics to be included in the trial.
Who should consider this trial
Good fit: Ideal candidates are individuals with unresectable hepatocellular carcinoma who are eligible for TARE and have not undergone curative surgery or transplantation.
Not a fit: Patients with disease that can be treated with curative surgery, ablation, or transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced liver cancer.
How similar studies have performed: Other studies have shown promise with similar combination therapies in treating liver cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with confirmed unresectable HCC * Participants with Lung dose threshold for Yttrium 90 glass microspheres of 30 Gy (equal or less than 30 Gy per treatment for glass) and an estimated Future liver remnant volume (FLRV) ≥ 30% of whole liver volume * Participants with no evidence of extrahepatic disease on any available imaging * Participants with one or more measurable lesions, unilobar disease for participants with segmental or right anterior/posterior portal vein invasion (Vp1/Vp2) and eligible for Yttrium 90 glass microspheres TARE. * Participants having Child-Pugh score class A. * Participants having ECOG performance status of 0 or 1 at enrollment * Adequate organ and marrow function Exclusion Criteria: * Disease amenable to curative surgery, ablation or transplantation. * Participants co-infected with HBV and HDV * Any history of nephrotic or nephritic syndrome. * Clinically significant (eg, active) cardiovascular disease * Participants with uncontrolled hypertension * History of hepatic encephalopathy * Known hereditary predisposition to bleeding or thrombosis; any prior or current evidence of bleeding diathesis. * Receipt of more than 1 prior embolization (TACE or TARE) treatment/procedure * Participant has received any prior anticancer systemic therapy for unresectable HCC. * History of arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment. * History of abdominal fistula or gastrointestinal (GI) perforation, non-healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
Where this trial is running
Aurora, Colorado and 24 other locations
- Research Site — Aurora, Colorado, United States (Recruiting)
- Research Site — Gainesville, Florida, United States (Recruiting)
- Research Site — Miami, Florida, United States (Not_yet_recruiting)
- Research Site — Miami, Florida, United States (Withdrawn)
- Research Site — Orlando, Florida, United States (Recruiting)
- Research Site — Atlanta, Georgia, United States (Recruiting)
- Research Site — Atlanta, Georgia, United States (Recruiting)
- Research Site — Chicago, Illinois, United States (Recruiting)
- Research Site — Boston, Massachusetts, United States (Recruiting)
- Research Site — Detroit, Michigan, United States (Recruiting)
- Research Site — Saint Louis, Missouri, United States (Recruiting)
- Research Site — Trenton, New Jersey, United States (Recruiting)
- Research Site — Buffalo, New York, United States (Recruiting)
- Research Site — New York, New York, United States (Recruiting)
- Research Site — Rochester, New York, United States (Withdrawn)
- Research Site — Chapel Hill, North Carolina, United States (Recruiting)
- Research Site — Columbus, Ohio, United States (Recruiting)
- Research Site — Portland, Oregon, United States (Recruiting)
- Research Site — Philadelphia, Pennsylvania, United States (Recruiting)
- Research Site — Houston, Texas, United States (Recruiting)
- Research Site — Charlottesville, Virginia, United States (Recruiting)
- Research Site — Fairfax, Virginia, United States (Withdrawn)
- Research Site — Seattle, Washington, United States (Recruiting)
- Research Site — Milwaukee, Wisconsin, United States (Recruiting)
- Research Site — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.