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NCT07166406 · ClinicalTrials.gov registry record · Phase 3
Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial
A Phase 3 study of Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 252
- Enrollment target
- 20
- Study locations
NCT07166406 is a Phase 3 study of Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8 that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 252 participants, above the 72-participant average among 16 other Advanced Hepatocellular Carcinoma trials with a reported enrollment target (250% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT07166406, a Phase 3 study of Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 252 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect 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. Durvalumab and tremelimumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). IO with monoclonal antibodies, such as 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- BIOLOGICAL Atezolizumab
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Bevacizumab
Study Locations (20)
California
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
- Palo Alto Medical Foundation-Fremont - Fremont
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- Palo Alto Medical Foundation-Camino Division - Mountain View
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Palo Alto Medical Foundation Health Care - Palo Alto
- Sutter Cancer Centers Radiation Oncology Services-Roseville - Roseville
- Sutter Roseville Medical Center - Roseville
- Sutter Medical Center Sacramento - Sacramento
- California Pacific Medical Center-Pacific Campus - San Francisco
- Sutter Pacific Medical Foundation - Santa Rosa
- Palo Alto Medical Foundation-Sunnyvale - Sunnyvale
Connecticut
- Smilow Cancer Hospital-Derby Care Center - Derby
- Smilow Cancer Hospital Care Center-Fairfield - Fairfield
- Smilow Cancer Hospital Care Center at Glastonbury - Glastonbury
- Smilow Cancer Hospital Care Center at Greenwich - Greenwich
- Smilow Cancer Hospital Care Center - Guilford - Guilford
- Smilow Cancer Hospital-Hamden Care Center - Hamden
Colorado
- Saint Mary's Hospital and Regional Medical Center - Grand Junction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2025-10-07 |
| Est. Completion | 2029-03-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07166406
The ClinicalTrials.gov registry entry for NCT07166406 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 72-participant average among 16 other Advanced Hepatocellular Carcinoma trials with a reported enrollment target (250% higher). The listed sponsor is NRG Oncology, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Advanced Hepatocellular Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07166406 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Connecticut, Colorado.
Frequently Asked Questions
What is clinical trial NCT07166406 about?
NCT07166406 is a clinical study titled "Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial". This phase III trial compares the effect 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 (advance...
What is the current status of trial NCT07166406?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 252 participants. The study started on 2025-10-07. Estimated completion is 2029-03-10.
What conditions does trial NCT07166406 study?
This clinical trial studies the following conditions: Advanced Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8.
What interventions are being tested in trial NCT07166406?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Atezolizumab (BIOLOGICAL), Magnetic Resonance Imaging (PROCEDURE), Bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT07166406?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07166406 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.