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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Completion pushed from Mar 10, 2029 to Mar 10, 2034v7
  2. Minor Trial sites expanded: 107 → 139 locationsv6
  3. Minor Re-verified, no change to tracked fieldsv5
  4. Notable Start date: Oct 7, 2025 to Feb 26, 2026 Enrollment reduced: 252 → 226 participants · Trial sites expanded: 83 → 107 locations · Trial arms changed: 6 → 2 · 5 morev4 Show 8 more changesShow less
    • Enrollment reduced: 252 → 226 participants
    • Trial sites expanded: 83 → 107 locations
    • Trial arms changed: 6 → 2
    • Primary completion date: Mar 9, 2029 to Mar 10, 2029
    • Interventions: Atezolizumab (Biological), Bevacizumab (Biological), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Durvalumab… to Atezolizumab (Biological), Bevacizumab (Biological), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Durvalumab…
    • Eligibility criteria revised
    • Secondary endpoints: 9 to 8
    • Study description expanded, about 20 words

    See this version in full on ClinicalTrials.gov ↗

  5. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Mar 10, 2029 to Mar 9, 2029 · Start date changed from estimate of Nov 27, 2025 to Oct 7, 2025v3 Show 2 more changesShow less
    • Primary completion date: Mar 10, 2029 to Mar 9, 2029
    • Start date changed from estimate of Nov 27, 2025 to Oct 7, 2025
  6. Notable Start date: Oct 2, 2025 to Nov 27, 2025v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07166406
Lead Sponsor NRG Oncology
Conditions Advanced Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8
Enrollment 226 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov