To hear about similar clinical trials, please enter your email below
Trial Title:
Atezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma
NCT ID:
NCT05908916
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AtezoBev with combined radiotherapy
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.
Arm group label:
Therapeutic arm
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Severance hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Contact:
Last name:
Do Young Kim
Phone:
82-2-2228-1992
Email:
dyk1025@yuhs.ac
Start date:
July 2023
Completion date:
July 2026
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05908916
