Ireland
--:--IST
Recruiting Phase 3

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

NCT07166406 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2026-02-26
Last updated
2026-08-17

Condition(s) studied

Advanced Hepatocellular CarcinomaStage III Hepatocellular Carcinoma AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8

Investigational drug(s) / intervention(s)

Atezolizumab →Bevacizumab →Biospecimen CollectionComputed TomographyDurvalumab →Ipilimumab →Magnetic Resonance ImagingNivolumab →Positron Emission TomographyQuestionnaire AdministrationStereotactic Body Radiation TherapyTremelimumab →

Atezolizumab: Given IV

Bevacizumab: Given IV

Biospecimen Collection: Undergo blood sample collection

Computed Tomography: Undergo CT and PET/CT

Durvalumab: Given IV

Ipilimumab: Given IV

Magnetic Resonance Imaging: Undergo MRI

Nivolumab: Given IV

Positron Emission Tomography: Undergo PET/CT

Questionnaire Administration: Ancillary studies

Stereotactic Body Radiation Therapy: Undergo liver SBRT

Tremelimumab: Given IV

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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).

Trial sites (139)

FacilityCityRegionStatus
Alta Bates Summit Medical Center-Herrick Campus Berkeley California Recruiting
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California Recruiting
Palo Alto Medical Foundation-Fremont Fremont California Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine California Recruiting
Palo Alto Medical Foundation-Camino Division Mountain View California Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California Recruiting
Palo Alto Medical Foundation Health Care Palo Alto California Recruiting
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California Recruiting
Sutter Roseville Medical Center Roseville California Recruiting
Sutter Medical Center Sacramento Sacramento California Recruiting
University of California Davis Comprehensive Cancer Center Sacramento California Recruiting
California Pacific Medical Center-Pacific Campus San Francisco California Recruiting
Sutter Pacific Medical Foundation Santa Rosa California Recruiting
Palo Alto Medical Foundation-Sunnyvale Sunnyvale California Recruiting
Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado Recruiting
UCHealth Memorial Hospital Central Colorado Springs Colorado Recruiting
Memorial Hospital North Colorado Springs Colorado Recruiting
Poudre Valley Hospital Fort Collins Colorado Recruiting
Cancer Care and Hematology-Fort Collins Fort Collins Colorado Recruiting
Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado Recruiting
UCHealth Greeley Hospital Greeley Colorado Recruiting
Medical Center of the Rockies Loveland Colorado Recruiting
Smilow Cancer Hospital-Derby Care Center Derby Connecticut Recruiting
Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut Recruiting
Smilow Cancer Hospital Care Center at Glastonbury Glastonbury Connecticut Recruiting
Smilow Cancer Hospital Care Center at Greenwich Greenwich Connecticut Recruiting
Smilow Cancer Hospital Care Center - Guilford Guilford Connecticut Recruiting
Smilow Cancer Hospital-Hamden Care Center Hamden Connecticut Recruiting
Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut Recruiting
Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut Recruiting
Yale University New Haven Connecticut Recruiting
Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut Recruiting
Smilow Cancer Hospital Care Center at Long Ridge Stamford Connecticut Recruiting
Smilow Cancer Hospital-Torrington Care Center Torrington Connecticut Recruiting
Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut Recruiting
Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut Recruiting
Smilow Cancer Hospital Care Center - Waterford Waterford Connecticut Recruiting
Helen F Graham Cancer Center Newark Delaware Recruiting
Medical Oncology Hematology Consultants PA Newark Delaware Recruiting
Christiana Care Health System-Christiana Hospital Newark Delaware Recruiting

+ 99 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07166406 on ClinicalTrials.gov ↗ ← All trials in Mexico