Clinical trial · Interventional
Atezolizumab and BEvacizumab With STereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma
Atezolizumab and Bevacizumab With Stereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma
NCT06595108CI-TRIAL-00082160A-BESTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine the efficacy and safety of atezolizumab-bevacizumab combination therapy plus stereotactic body radiotherapy(SBRT) in patients with advanced hepatocellular carcinoma, Subjects will start SBRT for one or more primary cancers and/or metastatic lesions and no more than 5 sites within two month before and after the start date of atezolizumab-bevacizumab combination therapy. In this study, it is expected to improve the treatment response rate of atezolizumab-bevacizumab therapy, which is currently first-line chemotherapy but has a low treatment response rate.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Chemotherapy | — | UNRESOLVED | — |
| Stereotactic Body Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic body radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with advanced hepatocellular carcinoma
- description
- Patients indicated for the first-line atezolizumab-bevacizumab combination therapy are the primary subjects, and those voluntarily agree to the clinical trial after explanation of the study, are enrolled in the study.
- interventionNames
- Radiation: Stereotactic body radiotherapy
Primary outcomes (1)
- measure
- Progression-free survival at 6 month
- timeFrame
- 6 months after registration
- description
- The primary endpoint is to improve 6-month progression-free survival rate in the treatment group compared to those existing literature. Progression-free survival and overall survival are evaluated using the Kaplan-Meier curve. Verified through one sample proportion test.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDMeng L, Xu J, Ye Y, Wang Y, Luo S, Gong X. The Combination of Radiotherapy With Immunotherapy and Potential Predictive Biomarkers for Treatment of Non-Small Cell Lung Cancer Patients. Front Immunol. 2021 Sep 21;12:723609. doi: 10.3389/fimmu.2021.723609. eCollection 2021. PMID 34621270
- BACKGROUNDDemaria S, Golden EB, Formenti SC. Role of Local Radiation Therapy in Cancer Immunotherapy. JAMA Oncol. 2015 Dec;1(9):1325-32. doi: 10.1001/jamaoncol.2015.2756. PMID 26270858
- BACKGROUNDDemaria S, Guha C, Schoenfeld J, Morris Z, Monjazeb A, Sikora A, Crittenden M, Shiao S, Khleif S, Gupta S, Formenti SC, Vikram B, Coleman CN, Ahmed MM. Radiation dose and fraction in immunotherapy: one-size regimen does not fit all settings, so how does one choose? J Immunother Cancer. 2021 Apr;9(4):e002038. doi: 10.1136/jitc-2020-002038. PMID 33827904
- BACKGROUNDByun HK, Kim N, Park S, Seong J. Acute severe lymphopenia by radiotherapy is associated with reduced overall survival in hepatocellular carcinoma. Strahlenther Onkol. 2019 Nov;195(11):1007-1017. doi: 10.1007/s00066-019-01462-5. Epub 2019 Apr 15. PMID 30989242
- BACKGROUNDTheelen WSME, Peulen HMU, Lalezari F, van der Noort V, de Vries JF, Aerts JGJV, Dumoulin DW, Bahce I, Niemeijer AN, de Langen AJ, Monkhorst K, Baas P. Effect of Pembrolizumab After Stereotactic Body Radiotherapy vs Pembrolizumab Alone on Tumor Response in Patients With Advanced Non-Small Cell Lung Cancer: Results of the PEMBRO-RT Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Sep 1;5(9):1276-1282. doi: 10.1001/jamaoncol.2019.1478. PMID 31294749
- BACKGROUNDLuke JJ, Lemons JM, Karrison TG, Pitroda SP, Melotek JM, Zha Y, Al-Hallaq HA, Arina A, Khodarev NN, Janisch L, Chang P, Patel JD, Fleming GF, Moroney J, Sharma MR, White JR, Ratain MJ, Gajewski TF, Weichselbaum RR, Chmura SJ. Safety and Clinical Activity of Pembrolizumab and Multisite Stereotactic Body Radiotherapy in Patients With Advanced Solid Tumors. J Clin Oncol. 2018 Jun 1;36(16):1611-1618. doi: 10.1200/JCO.2017.76.2229. Epub 2018 Feb 13.