Back to search results

HELIO-RT Trial: Immunotherapy with or without Radiation for Advanced Liver Cancer

This study, called HELIO-RT, is looking at new ways to treat advanced liver cancer (hepatocellular carcinoma). It compares giving immunotherapy (IO) drugs like atezolizumab and bevacizumab, or durvalumab, with or without stereotactic body radiation therapy (SBRT). Immunotherapy uses your body's own immune system to fight cancer cells. Bevacizumab works by stopping new blood vessels from forming, which tumors need to grow. The main goal is to see if adding SBRT to immunotherapy helps people live longer. You might be able to join if you are 18 or older and have advanced liver cancer that has been confirmed by a doctor. The study aims to enroll 226 participants, but its current status is unclear.

Study design
This is an interventional study comparing two treatment approaches for advanced liver cancer. It plans to enroll 226 participants.
What's involved
You would undergo blood sample collection, CT scans, and PET/CT scans. You would receive either atezolizumab and bevacizumab, or durvalumab, given intravenously (IV).
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be tracked from the date you are randomly assigned to a treatment group until the date of death or last follow-up, for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07166406

Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial

Recruiting
PHASE3Ages 18+InterventionalTreatment
NRG Oncology
~226 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:AtezolizumabBevacizumabBiospecimen CollectionComputed TomographyDurvalumabIpilimumab

At a glance

Recruiting sites
139 of 139 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over From the date of randomization to the date of death or last follow-up, assessed up to 5 years

Conditions

Advanced Hepatocellular Carcinoma
Stage III Hepatocellular Carcinoma AJCC v8
Stage IV Hepatocellular Carcinoma AJCC v8

Explore related trials

Hepatocellular Carcinoma

NCT07166406

Where you'd take part

This study runs at 139 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Allegiance Health

    Jackson, Michiganstudy coordinator listed

    Recruiting

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, Californiastudy coordinator listed

    Recruiting

  • California Pacific Medical Center-Pacific Campus

    San Francisco, Californiastudy coordinator listed

    Recruiting

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Coloradostudy coordinator listed

    Recruiting

  • Carle at The Riverfront

    Danville, Illinoisstudy coordinator listed

    Recruiting

  • Carle Cancer Center

    Urbana, Illinoisstudy coordinator listed

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinoisstudy coordinator listed

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jennifer Y Wo · PRINCIPAL_INVESTIGATOR · NRG Oncology

Who to contact

Site Public Contact
[email protected]
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

PRIOR TO STEP 1 REGISTRATION:
Diagnosis of hepatocellular carcinoma (HCC) by at least 1 criterion listed below:
Pathologically (histologically or cytologically) proven diagnosis of HCC (strongly recommended)
Radiographically proven (American Association for the Study of Liver Diseases \[AASLD\] criteria) diagnosis of HCC by multiphasic MRI and/or CT scan is allowed.
For patients with a prior or concurrent malignancy, pathologic confirmation of hepatocellular cancer is required.
HCC macrovascular invasion, defined as enhancing vascular thrombosis demonstrating arterial enhancement and venous or delayed venous washout on multiphasic MRI and/or CT is required.
Presence of extrahepatic metastatic disease on CT chest and CT or MRI pelvis, or PET/CT chest/abdomen/pelvis is permitted.
5 or fewer discrete intrahepatic parenchymal foci of HCC.
Total maximal sum of hepatocellular carcinoma tumors, as a single conglomerate, multiple lesions, or infiltrative HCC \< 20 cm in total summed diameter.
No direct primary tumor extension into the stomach, duodenum, small bowel, or large bowel.
No known fibrolamellar HCC, sarcomatoid HCC, or biphenotypic HCC.
Child-Pugh class A or B7 liver function.
Age ≥ 18.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Not pregnant and not nursing
Negative urine or serum pregnancy test (in persons of childbearing potential) within 30 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3.
Platelets ≥ 60,000 cells/mm\^3.
Hemoglobin ≥ 8g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 8g/dl is acceptable).
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 6 x institutional upper limit of normal (ULN).
Total bilirubin \< 4 x institutional ULN.
Creatinine clearance (CrCL) ≥ 30 mL/min/1.73 m\^2 by the Cockcroft-Gault formula.
For treatment of HCC:
Prior surgical resection, transarterial chemoembolization (TACE), and ablation are permitted.
No prior systemic therapy or transarterial radioembolization (TARE) for HCC.
No history of liver transplantation.
For prior treatment for any malignancy:
Prior systemic therapy for a different cancer is allowable, except for prior immunotherapy.
No prior radiotherapy to the region of the study cancer that would result in significant overlap of radiation therapy fields that would lead to excessive cumulative toxicity at the discretion of the investigator.
No medical contraindication to the standard of care immunotherapy.
For patients to be treated with atezolizumab/bevacizumab:
No history of a gastrointestinal (GI) bleed or other clinically significant bleeding event within 6 months prior to study registration.
Systemic immunostimulatory agents (including, but not limited to, interferons and interleukin-2 \[IL-2\]) are prohibited within 4 weeks or five drug elimination half-lives (whichever is longer) prior to registration and during the study period.
No history of allergic reaction to the systemic therapy agent(s), compounds of similar chemical or biologic composition to the systemic therapy agent(s) (or any of its excipients).
PRIOR TO STEP 2 RANDOMIZATION:
Obtain confirmation of payment coverage (insurance or other) for both possible treatment arms.

What this trial measures

  • Overall survival (OS)From the date of randomization to the date of death or last follow-up, assessed up to 5 years

    Will be estimated by the Kaplan-Meier method (Kaplan 1958). The distributions of the OS estimates between the two arms will be compared using a log-rank test. The Cox regression model will be used to analyze the effects of factors, in addition to treatment, including, but not limited to stratification factors, which may be associated with OS. The primary analysis will happen after at least 150 OS events (deaths) have occurred and will be tested with a 1-sided significance level of 0.022 (level based on not having stopped at either of the 2 planned interim analyses).