Clinical trial 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 being studied to treat advanced liver cancer. It is designed to help the body's immune system attack tumor cells.
Also referred to as Tecentriq.
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 study is testing whether adding focused radiation to immune drugs works better than immune drugs alone. It looks at how well this mix helps people with advanced liver cancer live longer.
- Who it's for
- You may be able to join if you have advanced liver cancer that has spread to nearby tissue or other parts of the body.
- What's involved
- You would get immune drugs to help your body fight the cancer. Some people would also get focused radiation to shrink the tumor.
- Time commitment
- The study lasts for a set time, and you would need to come in for regular check-ins and tests.
- 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
- 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.
- HCC macrovascular invasion, defined as enhancing vascular thrombosis demonstrating arterial enhancement and venous or delayed venous washout on...
- Presence of extrahepatic metastatic disease on CT chest and CT or MRI pelvis, or PET/CT chest/abdomen/pelvis is permitted.
See the full eligibility criteria
- 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.
- 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.
- 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.
- 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.
- 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).
- Obtain confirmation of payment coverage (insurance or other) for both possible treatment arms.
The study team makes the final eligibility decision.
Where it is enrolling
- 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
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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, so 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, but 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?
This study is enrolling now at 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 locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.