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  3. NRG-GI012

Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)

Short Title: NRG-GI012


Enrollment Status: Recruiting

NCT #: NCT07166406

Specialty Area: Oncology

Condition Studied: Hepatocellular Carcinoma

Age Groups: Adult; Older Adult

Phase: III


Study Information

Summary / Purpose

The purpose of this study is to compare the usual treatment of immunotherapy-based drug treatment alone to using liver stereotactic body radiation therapy (SBRT) plus the usual treatment.

Study Type: Interventional
Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:
  • Adults 18+ years of age
  • Diagnosis of hepatocellular carcinoma (HCC)
  • HCC macrovascular invasion
  • Cannot be pregnant or nursing
  • No prior systemic therapy or transarterial radioembolization

What's Involved

Participation in the study will include:
  • Random assignment to receive immunotherapy alone or immunotherapy combined with stereotactic body radiation therapy (SBRT) to the liver
  • Receiving immunotherapy medications by intravenous (IV) infusion as determined by the study treatment plan
  • Computed tomography (CT) scan
  • Magnetic resonance imaging (MRI)
  • Fludeoxyglucose (FDG) positron emission tomography (PET) scan
  • Blood sample collection

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Complete Study Details: https://clinicaltrials.gov/study/NCT07166406

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.