A Single-arm Phase II Trial of Atezolizumab and Bevacizumab With Combined Radiotherapy in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
Overview
- Phase
- Phase 2
- Intervention
- AtezoBev with combined radiotherapy
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Yonsei University
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •clinically or histologically diagnosed HCC;
- •HCC with Vp2-Vp4 portal vein invasion;
- •intact liver function with Child-Pugh class A;
- •adequate size of RT field;
- •intact performance with ECOG below 2;
- •non-pregnant with acceptable contraception in premenopausal women);
- •without other life-threatening diseases;
- •ability to provide written informed consent and to comply with all study conditions.
Exclusion Criteria
- •Active uncontrolled infection;
- •Current or history (\< or = 5 years) of advanced malignancies in the other organs;
- •History of liver transplantation;
- •miliary HCC which incompatible external beam RT
Arms & Interventions
Therapeutic arm
AtezoBev with combined radiotherapy
Intervention: AtezoBev with combined radiotherapy
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 2 years (per 9 weeks)
Duration between AtezoBev initiation and tumor progression by mRECIST or patient's death