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

Recruiting now · Phase 3

Conditions studied: Advanced Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8

In brief

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.

Key facts

Study ID

NCT07166406

Run by

NRG Oncology

People needed

226

Starts

2026-02-26

Expected to finish

2029-03-10

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States (enrolling)
• Palo Alto Medical Foundation-Fremont — Fremont, California, United States (enrolling)
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States (enrolling)
• Palo Alto Medical Foundation-Camino Division — Mountain View, California, United States (enrolling)
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)
• Palo Alto Medical Foundation Health Care — Palo Alto, California, United States (enrolling)
• Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville, California, United States (enrolling)
• Sutter Roseville Medical Center — Roseville, California, United States (enrolling)
• Sutter Medical Center Sacramento — Sacramento, California, United States (enrolling)
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States (enrolling)
• Sutter Pacific Medical Foundation — Santa Rosa, California, United States (enrolling)
• Palo Alto Medical Foundation-Sunnyvale — Sunnyvale, California, United States (enrolling)
• Rocky Mountain Cancer Centers-Penrose — Colorado Springs, Colorado, United States (enrolling)
• UCHealth Memorial Hospital Central — Colorado Springs, Colorado, United States (enrolling)
• Memorial Hospital North — Colorado Springs, Colorado, United States (enrolling)
• Poudre Valley Hospital — Fort Collins, Colorado, United States (enrolling)
• Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado, United States (enrolling)
• Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States (enrolling)
• UCHealth Greeley Hospital — Greeley, Colorado, United States (enrolling)
• Medical Center of the Rockies — Loveland, Colorado, United States (enrolling)
• Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center-Fairfield — Fairfield, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center at Glastonbury — Glastonbury, Connecticut, United States (enrolling)
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States (enrolling)

Full record on ClinicalTrials.gov

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