Clinical trial · Observational
Efficacy and Safety of SBRT Combined With Atezolizumab Plus Bevacizumab vs Atezolizumab Plus Bevacizumab in Treating Unresectable Advance Hepatocellular Carcinoma.
Efficacy and Safety of SBRT Combined With Atezolizumab Plus Bevacizumab vs Atezolizumab Plus Bevacizumab in Treating Unresectable Advance Hepatocellular Carcinoma (SAB - A Prospective Observational Study).
- 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)
SBRT, atezolizumab, and bevacizumab have different mechanisms of action and can potentially have synergistic effects when combined. SBRT delivers targeted radiation to the tumor, while atezolizumab enhances the immune response, and bevacizumab inhibits angiogenesis. The combination of SBRT with atezolizumab and bevacizumab will result in improved tumor response rates as compared to atezolizumab and bevacizumab alone in patients with advance unresectable hepatocellular carcinoma (HCC). Up until now, no study has been done that has compared SBRT with atezolizumab, and bevacizumab in unresectable advance hepatocellular carcinoma. With this study, investigator aim to study to compare the efficacy and safety of SBRT combined with atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in the treatment of unresectable advance hepatocellular carcinoma (HCC).
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- SBRT+Atezolizumab+Bevacizumab
- interventionNames
- Other: No intervention
- label
- Atezolizumab+Bevacizumab
- interventionNames
- Other: No intervention
Primary outcomes (1)
- measure
- Objective response rate (ORR), which is defined as the proportion of patients with complete response (CR) and partial response (PR) at 6 months . CR or PR is assessed in accordance with mRECIST.
- timeFrame
- 6 months
Secondary outcomes (15)
- measure
- Overall survival
- timeFrame
- 3 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria:
1. Age; 18-70 years.
2. Unresectable advance HCC with PVTT
3. At least one measurable (measurable according to Response Evaluation Criteria In Solid Tumors (mRECIST V.1.1)), untreated lesions.
4. Patients with hepatitis B virus (HBV) infection: HBV-DNA \<500 IU/mL obtained within 28 days before the start of study treatment and received anti-HBV treatment for at least 28 days before entering the study.
5. Patients with hepatitis C virus (HCV) infection: HCV-DNA \<500 IU/mL obtained within 28 days before the start of study treatment and received anti-HCV treatment for at least 28 days before entering the study.
6. Maximum diameter of tumor ≤ 15cm
7. Maximum number of tumor nodules ≤5
8. Liver function: Child-Pugh class A, B7; normal liver volume is more than 800cm3.
9. Karnofsky performance status ≥ 80%
10. The expected survival of the patient is more than 6 months.
11. Agree to accept post-procedure follow-up required by the design of this study.
12. The following conditions are met:
i. Platelet≥60×109/L; White blood cell≥3.0×109/L; Hemoglobin≥85 g/L; Serum creatinine≤1.4 × upper limit;. PT-INR ≤1.7
Exclusion Criteria:
1. Patients with untreated or incompletely treated esophageal and/or gastric varices with associated bleeding or at high risk of bleeding.
2. Coinfection with HBV and hepatitis C virus (HCV).
3. Symptomatic, untreated or progressively progressive central nervous system (CNS) metastases.
4. The patient cannot receive follow-up or is participating in other clinical trials.
5. Subjects deemed unsuitable for inclusion in this study by the investigator.
6. Current or past autoimmune disease or immunodeficiency.
7. History of leptomeningitis.
8. Idiopathic pulmonary fibrosis, organising pneumonia or evidence of active pneumonia on chest.
9. Known active tuberculosis.
10. Severe infection within 4 weeks prior to initiation of study treatment
11. A potential subject who meets any of the following criteria will be excluded from participation in this study:
i) Previous radiotherapy to the liver ii) Known current pregnancy iii) Loss of fat planes of tumor with organ at risk like the esophagus, stomach, duodenum, small bowel on CT or on MRIReferences
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