Study Details

Open

A US study to evaluate transarterial radioembolization (TARE) in combination with durvalumab and bevacizumab therapy in people with hepatocellular carcinoma amenable to TARE

The purpose of this study is to measure the efficacy and safety of durvalumab IV solution plus bevacizumab IV solution after transarterial radioembolization(Y90 glass microsphere TARE) in participants with unresectable HCC amenable to locoregional therapy.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

You will be in the study for 3 periods: screening, study treatment, and follow-up (for an expected average of about 2 years), which is described below. You and your study doctor will decide on the length of your stay in this study based on how your cancer responds to the durvalumab and bevacizumab study treatment, and your willingness to continue in the study. You will be expected to complete all study visits (can include vitals, urinalysis, EKG, labs, MD visits, treatment,biopsies, imaging, questionnaires, etc.), report any side effects you may have, any changes of medications, and any additional treatments. You will be in the study until you are no longer receiving benefit from the study treatment, the study ends, your disease worsens, or you have unacceptable side effects from the study treatment. Survival follow-up continues through study withdrawal, study closure, or death

Incentives

In-person visits:
9

Phone or online visits:
1

Total length of participation:
36 months (Survival follow-up continues through study withdrawal, study closure, or death)

Looking for Specific Volunteers

Able to participate:

HCC confirmed by imaging or biopsy.
No evidence of extrahepatic disease on imaging.
Disease must be amenable to complete treatment with TARE in one session.
The participant must meet all Y90 dosimetry restraints.
Adequate organ and marrow function as defined by lab values in protocol.

Not eligible if:

Any evidence of diseases that in the opinion of the investigator would make it undesirable for the patient to participate in the trial.
Persistent toxicites from previous anticancer therapy greater than Grade 1 in severity.
Disease amenable to curative surgery, curative ablation, or transplantation.
Any contraindication to angiography or selective visceral catheterization
Untreated esophageal or gastric varices with bleeding or at high risk for bleeding

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Jingquan Jia
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Liver)

IRB Number

23-2524

ClinicalTrials.gov

NCT06040099