Skip to main content
Clinical Trials/NCT05908916
NCT05908916
Not yet recruiting
Phase 2

A Single-arm Phase II Trial of Atezolizumab and Bevacizumab With Combined Radiotherapy in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

Yonsei University1 site in 1 country51 target enrollmentJuly 2023

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.

Registry
clinicaltrials.gov
Start Date
July 2023
End Date
July 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Study Sites (1)

Loading locations...

Similar Trials