Back to resultsAtezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Not yet recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AtezoBev with combined radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria: age ≥19; 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
Sites / Locations
- Severance hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Therapeutic arm
Arm Description
AtezoBev with combined radiotherapy
Outcomes
Primary Outcome Measures
Progression-free survival
Duration between AtezoBev initiation and tumor progression by mRECIST or patient's death
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05908916
Brief Title
Atezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma
Official Title
A Single-arm Phase II Trial of Atezolizumab and Bevacizumab With Combined Radiotherapy in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic arm
Arm Type
Experimental
Arm Description
AtezoBev with combined radiotherapy
Intervention Type
Drug
Intervention Name(s)
AtezoBev with combined radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Duration between AtezoBev initiation and tumor progression by mRECIST or patient's death
Time Frame
2 years (per 9 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥19;
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Do Young Kim
Phone
82-2-2228-1992
Email
dyk1025@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Do Young Kim
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Do Young Kim
Phone
82-2-2228-1992
Email
dyk1025@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Atezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma
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