Combining atezolizumab and bevacizumab with stereotactic body radiotherapy for advanced liver cancer
Atezolizumab and Bevacizumab With Stereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma
This study is testing if combining two cancer drugs with a specific type of radiation therapy can help people with advanced liver cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab, chemotherapy |
| Locations | 1 site (Yongin-si) |
| Trial ID | NCT06595108 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of a combination therapy using atezolizumab and bevacizumab alongside stereotactic body radiotherapy (SBRT) in patients with advanced hepatocellular carcinoma. Participants will receive SBRT for one or more primary cancers or metastatic lesions within two months before or after starting the combination therapy. The study will assess treatment response rates and monitor adverse events through a series of scheduled visits that include medical evaluations and quality of life questionnaires.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 80 with advanced, inoperable hepatocellular carcinoma and Child-Pugh class A liver function.
Not a fit: Patients with brain metastases or serious uncontrolled medical comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment response rates for patients with advanced hepatocellular carcinoma.
How similar studies have performed: While the combination of these therapies is being explored, the specific approach of this trial is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 19 to 80 years old 2. Liver function Child-Pugh class A 3. ECOG 0-1 4. Patient clinically or pathologically diagnosed with hepatocellular carcinoma 5. Advanced hepatocellular carcinoma that is inoperable 6. Satisfies the dose limits for normal organs and lesions of an appropriate size to be included in the scope of radiotherapy. Exclusion Criteria: 1. Brain metastases 2. Have a history of malignancy other than hepatocellular carcinoma within the last 5 years (except for malignancies with little risk of metastasis or death, e.g., adequately treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, tubular carcinoma in situ, or stage 1 uterine cancer.) 3. Subjects with a high probability of untreated gastric or esophageal varices or bleeding 4. Serious uncontrolled medical comorbidities 5. History of liver transplant surgery 6. Autoimmune liver disease
Where this trial is running
Yongin-si
- Yongin Severance Hospital — Yongin-si, South Korea (Recruiting)
Study contacts
- Principal investigator: Hwakyung BYUN, Phd — Severance Hospital
- Study coordinator: Hwakyung BYUN, Phd
- Email: hkbyun05@yuhs.ac
- Phone: 007981072098955
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.