OncoMatch/Clinical Trials/NCT07166406
Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial
Is NCT07166406 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments for advanced hepatocellular carcinoma.
Treatment: Atezolizumab · Bevacizumab · Durvalumab · Ipilimumab · Nivolumab · Tremelimumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy for HCC
No prior systemic therapy ... for HCC
Cannot have received: transarterial radioembolization (TARE) for HCC
No prior ... transarterial radioembolization (TARE) for HCC
Cannot have received: liver transplantation
No history of liver transplantation
Cannot have received: immunotherapy for any malignancy
Prior systemic therapy for a different cancer is allowable, except for prior immunotherapy
Cannot have received: radiotherapy to region of study cancer resulting in significant overlap of radiation therapy fields
Exception: at the discretion of the investigator
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
Lab requirements
Blood counts
ANC ≥ 1,500 cells/mm^3; platelets ≥ 60,000 cells/mm^3; hemoglobin ≥ 8g/dl (transfusion/intervention allowed)
Kidney function
Creatinine clearance (CrCL) ≥ 30 mL/min/1.73 m^2 by the Cockcroft-Gault formula
Liver function
Child-Pugh class A or B7 liver function; AST and ALT ≤ 6 x institutional ULN; total bilirubin < 4 x institutional ULN
Child-Pugh class A or B7 liver function. ANC ≥ 1,500 cells/mm^3. Platelets ≥ 60,000 cells/mm^3. Hemoglobin ≥ 8g/dl (transfusion/intervention allowed). AST and ALT ≤ 6 x institutional ULN. Total bilirubin < 4 x institutional ULN. Creatinine clearance (CrCL) ≥ 30 mL/min/1.73 m^2 by the Cockcroft-Gault formula.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Smilow Cancer Hospital-Derby Care Center · Derby, Connecticut
- Smilow Cancer Hospital Care Center-Fairfield · Fairfield, Connecticut
- Smilow Cancer Hospital Care Center at Glastonbury · Glastonbury, Connecticut
- Smilow Cancer Hospital Care Center at Greenwich · Greenwich, Connecticut
- Smilow Cancer Hospital Care Center - Guilford · Guilford, Connecticut
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07166406 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy for HCC, transarterial radioembolization (TARE) for HCC, liver transplantation disqualifies patients from enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages