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New treatment option for Advanced Hepatocellular Carcinoma
Official title Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial
ClinicalTrials.gov ID: NCT07166406
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for advanced hepatocellular carcinoma.
Also referred to as MPDL 3280A, MPDL 328OA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- For patients with a prior or concurrent malignancy, pathologic confirmation of hepatocellular cancer is required.
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Berkeley, California, United States
- Cameron Park, California, United States
- Fremont, California, United States
- Irvine, California, United States
- Mountain View, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Santa Rosa, California, United States
- Sunnyvale, California, United States
- Colorado Springs, Colorado, United States
- Fort Collins, Colorado, United States
- Grand Junction, Colorado, United States
- Greeley, Colorado, United States
- Loveland, Colorado, United States
- Derby, Connecticut, United States
- Fairfield, Connecticut, United States
- Glastonbury, Connecticut, United States
+ 92 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berkeley, California, United States; Cameron Park, California, United States; Fremont, California, United States; Irvine, California, United States; Mountain View, California, United States; Orange, California, United States and 106 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.