Immunotherapy + Radiation for Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether adding precise radiation therapy to standard immunotherapy improves treatment outcomes for advanced liver cancer compared to immunotherapy alone. The study compares different combinations of immunotherapy drugs, including Atezolizumab, Bevacizumab, Ipilimumab, Nivolumab, and Tremelimumab. Some of these drugs block tumor growth and prevent spreading, while others cut off the blood supply tumors need to grow. People with liver cancer that has spread beyond the liver, and who have not received certain other treatments, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, systemic immunostimulatory agents (like interferons and interleukin-2) are not allowed within 4 weeks before joining and during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown promising safety for the treatments in this trial. Research indicates that the combination of tremelimumab and durvalumab is generally well-tolerated for liver cancer. One study showed that these drugs can control the disease while maintaining stable liver function, with manageable side effects.
For the combination of atezolizumab and bevacizumab, findings suggest it is a safe option for liver cancer patients. Specifically, one study noted that while some serious side effects occurred, the overall safety was considered acceptable.
Nivolumab and ipilimumab together have also been studied and found to have manageable safety. Past trials showed that most side effects were not severe, and the treatment effectively controlled cancer growth.
When combined with stereotactic body radiation therapy (SBRT), these drugs still show acceptable safety. This type of radiation targets tumors precisely, helping to protect healthy tissue. Studies combining SBRT with these drugs reported strong safety, with few severe side effects.
Overall, past research has shown that the treatments under study can be safe for patients with advanced liver cancer.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the investigational treatments for liver cancer because they combine immunotherapy with radiation in new ways. Unlike standard treatments that primarily use chemotherapy, these combinations leverage drugs like atezolizumab, bevacizumab, tremelimumab, durvalumab, nivolumab, and ipilimumab, which enhance the body's immune response to target cancer cells more effectively. The experimental use of stereotactic body radiation therapy (SBRT) alongside immunotherapy is particularly promising, as it may boost the immune-stimulating effects of these drugs. This approach has the potential to improve outcomes by attacking the cancer from multiple angles, offering hope for better control of the disease.
What evidence suggests that this trial's treatments could be effective for liver cancer?
Research has shown that different combinations of immunotherapy drugs, such as tremelimumab with durvalumab, yield promising results for treating liver cancer. In this trial, some participants will receive tremelimumab and durvalumab, while others will receive this combination with stereotactic body radiation therapy (SBRT). Atezolizumab combined with bevacizumab is another treatment option, with some participants receiving this combination alone and others with SBRT. Nivolumab and ipilimumab together have provided significant survival benefits for liver cancer patients; in this trial, some participants will receive this combination alone, while others will receive it with SBRT. Adding SBRT to these immunotherapy treatments may enhance their effectiveness by accurately targeting and shrinking tumors, potentially leading to better outcomes than using immunotherapy alone.36789
Are You a Good Fit for This Trial?
This trial is for patients with advanced liver cancer, including those with up to five distinct liver tumors and a total tumor size less than 20 cm. It's open to individuals who have had their diagnosis confirmed pathologically or radiographically. Patients must not have certain rare types of liver cancer or direct tumor extension into the gastrointestinal tract, and should have relatively preserved liver function (Child-Pugh class A or B7).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive IO-based systemic treatments with or without liver SBRT, depending on the arm they are randomized to
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Bevacizumab
- Ipilimumab
- Nivolumab
- Stereotactic Body Radiation Therapy
- Tremelimumab
Trial Overview
The HELIO-RT Trial is comparing immunotherapy drugs alone versus in combination with Stereotactic Body Radiation Therapy (SBRT) for treating advanced hepatocellular cancer. Immunotherapies being tested include atezolizumab, bevacizumab, durvalumab, tremelimumab, nivolumab, and ipilimumab.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Active Control
Patients undergo liver SBRT QD, QOD, or twice weekly for 5 fractions over up to 3 weeks. Patients receive nivolumab and ipilimumab IV every 3 weeks for up to 4 doses followed by nivolumab IV every 4 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, chest CT and CT and/or MRI throughout the study and may also undergo PET/CT prior to registration.
Patients undergo liver SBRT QD, QOD, or twice weekly for 5 fractions over up to 3 weeks. Patients also receive tremelimumab IV once and durvalumab IV every 4 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, chest CT and CT and/or MRI throughout the study and may also undergo PET/CT prior to registration.
Arm 2 treatment A (atezolizumab, bevacizumab, SBRT) Patients undergo liver SBRT QD, QOD, or twice weekly for 5 fractions over up to 3 weeks. Patients also receive atezolizumab and bevacizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, chest CT and CT and/or MRI throughout the study and may also undergo PET/CT prior to registration.
Patients receive tremelimumab IV once and durvalumab IV every 4 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, chest CT and CT and/or MRI throughout the study and may also undergo PET/CT prior to registration.
Patients receive atezolizumab and bevacizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, chest CT and CT and/or MRI throughout the study and may also undergo PET/CT prior to registration.
Patients receive nivolumab and ipilimumab IV every 3 weeks for up to 4 doses followed by nivolumab IV every 4 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, chest CT and CT and/or MRI throughout the study and may also undergo PET/CT prior to registration.
Find a Clinic Near You
Who Is Running the Clinical Trial?
NRG Oncology
Lead Sponsor
Citations
Three-year overall survival in unresectable hepatocellular ...
Conclusions: In a real-world setting, the 3-year OS for uHCC patients treated with atezolizumab/bevacizumab was 25.3%, rising to 31.6% among ...
Atezolizumab plus Bevacizumab in Unresectable ...
In patients with unresectable hepatocellular carcinoma, atezolizumab combined with bevacizumab resulted in better overall and progression-free survival ...
Long-term survival outcomes of atezolizumab plus ...
Conclusions: In patients with advanced HCC, Atezo-Bev treatment led to a notable proportion achieving long-term survival, especially in patients ...
Long-term survival of patients who received atezolizumab ...
Among patients with advanced HCC treated with first-line Atezo-Bev, approximately 30% survived beyond 3 years. The absence of intrahepatic ...
Updated efficacy and safety data from IMbrave150
IMbrave150 demonstrated that atezolizumab plus bevacizumab led to significantly improved overall survival (OS) and progression-free survival ...
Updated efficacy and safety data from IMbrave150
At this updated analysis done 12 months later, median overall survival was 5.8 months longer with atezolizumab plus bevacizumab than sorafenib, ...
Atezolizumab plus bevacizumab vs. sorafenib for ...
A phase II trial of bevacizumab monotherapy for non-metastatic hepatocellular carcinoma led to an objective response rate of 13% and a median PFS of 6.9 months.
Bevacizumab combined with atezolizumab or sintilimab as ...
Adverse events were observed in 14 patients (70%). Adverse events of grade 3 or worse occurred in six patients (30%). Conclusions: The ...
Efficacy and safety of atezolizumab plus bevacizumab ...
Background: Atezolizumab plus bevacizumab has been proved to have promising antitumor activity and tolerable safety in patients with unresectable hepatocellular ...
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