Immunotherapy for Advanced Liver Cancer

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

Recruiting Phase 3 Interventional Study
Advanced Hepatocellular Carcinoma Stage III Hepatocellular Carcinoma AJCC v8 Stage IV Hepatocellular Carcinoma AJCC v8
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
226 (estimated)
Sponsor
NRG Oncology · Other
Who this trial is looking for

This trial is looking for adults with advanced liver cancer to see if a combination of immunotherapy and radiation therapy can help them live longer. Participants will receive either immunotherapy alone or with radiation treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with liver cancer.
  • I have liver cancer that has spread to other areas.
  • I am 18 years old or older.
  • I have good liver function.
  • I have not had recent surgery for liver cancer.
  • I have a performance status of 0-2.
  • I do not have a history of certain types of liver cancer.
  • I am not pregnant or nursing.

You may not be able to join if

  • I have had significant bleeding in the last 6 months.
  • I have received prior immunotherapy.
  • I have had a liver transplant.
  • I have a medical condition that prevents me from receiving immunotherapy.
  • I have a previous invasive cancer treatment that overlaps with this study.
  • I have an allergy to any of the study medications.
  • I cannot confirm insurance coverage for the treatment.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 bev…
Trial Locations
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Eligibility Criteria
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 Stud…
Contacts

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