Hepatocellular Carcinoma
Conditions
Brief summary
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.
Interventions
DRUGAtezoBev with combined radiotherapy
Atezolizumab (1200mg) and Bevacizumab (15mg/kg) are administered to patients once for each cycle with 3-week intervals, and additional radiotherapy (iGTV 50-60 Gy, CTV 40Gy, PTV 30Gy / 10Fx) for the mass or portal vein tumor thrombosis is performed before second cycle of AtezoBev.
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2 years (per 9 weeks) | Duration between AtezoBev initiation and tumor progression by mRECIST or patient's death |
Countries
South Korea
Contacts
Primary ContactDo Young Kim
Outcome results
None listed