Clinical trial · Interventional
Atezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma
A Single-arm Phase II Trial of Atezolizumab and Bevacizumab With Combined Radiotherapy in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
- 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)
Atezolizumab plus Bevacizumab combination therapy (AtezoBev) is well-known 1st-line therapy for advanced hepatocellular carcinoma (HCC). However, there are unmet needs for patients with advanced HCC who do not respond to AtezoBev. External beam radiotherapy (RT) is another well-known locoregional therapy for HCC that induces inflammatory cascade and abscopal effect as a systemic anticancer effect and enhances the effect of AtezoBev. Therefore, the investigators aim to verify the effect of AtezoBev plus RT for advanced HCC through this single-center, prospective phase II one-armed cohort study over three years. This study recruits 51 patients to verify the effect of the intervention. Atezolizumab (1200mg) and Bevacizumab (15mg/kg) are administered to patients once for each cycle at 3-week intervals, and additional radiotherapy for the mass or portal vein tumor thrombosis is performed before second cycle of AtezoBev. The primary endpoint is progression-free survival by using response evaluation with modified RECIST.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AtezoBev with combined radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therapeutic arm
- description
- AtezoBev with combined radiotherapy
- interventionNames
- Drug: AtezoBev with combined radiotherapy
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 2 years (per 9 weeks)
- description
- Duration between AtezoBev initiation and tumor progression by mRECIST or patient's death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. age ≥19; 2. clinically or histologically diagnosed HCC; 3. HCC with Vp2-Vp4 portal vein invasion; 4. intact liver function with Child-Pugh class A; 5. adequate size of RT field; 6. intact performance with ECOG below 2; 7. non-pregnant with acceptable contraception in premenopausal women); 8. without other life-threatening diseases; 9. ability to provide written informed consent and to comply with all study conditions. Exclusion Criteria: 1. Active uncontrolled infection; 2. Current or history (\< or = 5 years) of advanced malignancies in the other organs; 3. History of liver transplantation; 4. miliary HCC which incompatible external beam RT
References
Publications (0)
Data not yet available