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RECRUITING

NCT07166406

PHASE3

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

Sponsor: NRG Oncology

View on ClinicalTrials.gov

Summary

This phase III trial compares the effect of immunotherapy (IO) with stereotactic body radiation therapy (SBRT) to IO alone in treating patients with liver cancer (hepatocellular cancer) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). The usual approach is treatment with IO-based drug combinations, such as atezolizumab and bevacizumab, durvalumab and tremelimumab, or ipilimumab and nivolumab. IO with monoclonal antibodies, such as durvalumab, tremelimumab, atezolizumab, nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving IO with SBRT may be more effective than IO alone in helping patients with advanced hepatocellular cancer live longer.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

226

Start Date

2026-02-26

Completion Date

2029-03-10

Last Updated

2026-04-08

Healthy Volunteers

Conditions

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

Interventions

BIOLOGICAL

Atezolizumab

Given IV

BIOLOGICAL

Bevacizumab

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT and PET/CT

BIOLOGICAL

Durvalumab

Given IV

BIOLOGICAL

Ipilimumab

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Stereotactic Body Radiation Therapy

Undergo liver SBRT

BIOLOGICAL

Tremelimumab

Given IV

Inclusion Criteria: * 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.

Locations (107)

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Palo Alto Medical Foundation-Fremont

Fremont, California, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Sutter Roseville Medical Center

Roseville, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

UCHealth Greeley Hospital

Greeley, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, United States

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, United States

Smilow Cancer Hospital Care Center at Glastonbury

Glastonbury, Connecticut, United States

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, United States

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, United States

Smilow Cancer Hospital-Hamden Care Center

Hamden, Connecticut, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, United States

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, United States

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, United States

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, United States

Grady Health System