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Trial Title:
Atezolizumab Plus Bevacizumab Alone or Combined With External Beam Radiotherapy for HCC With Macrovascular Invasion
NCT ID:
NCT05992220
Condition:
Hepatocellular Carcinoma
Hepatocellular Cancer
Hepatocellular Carcinoma Non-resectable
Hepatocellular Carcinoma Stage IV
Liver Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Bevacizumab
Atezolizumab
Antibodies, Monoclonal
Conditions: Keywords:
HCC; vascular invasion; portal vein tumor thrombosis; BCLC stage C
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
randomized, multicenter, open-label study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Atezolizumab plus bevacizumab, combined EBRT to vascular invasion
Description:
The external beam radiotherapy will commence after day 2 of the first cycle of
atezolizumab+bevacizumab, and will be delivered in accordance with institutional
protocol.
3D-conformal radiotherapy technique is used to determine target volumes, radiation ports,
and dose prescriptions by using a 3D radiotherapy planning system.
The gross tumor volume (GTV) includes vascular invasion and a 2-cm margin into the
contiguous HCC. The GTV can consist of the entire HCC and vascular invasion at the
discretion of the investigator.
The target dose is 45 Gy, however, the total dose can be reduced as low as 30 Gy
according to the liver function, liver volumes, or the maximum dose to the
stomach/duodenum during the planning process according to the judgment of the radiation
oncologist of each participating sites.
Arm group label:
Radiotherapy combination
Intervention type:
Drug
Intervention name:
Atezolizumab plus bevacizumab
Description:
Atezolizumab plus bevacizumab q3w
Arm group label:
Atezolizumab+Bevacizumab
Summary:
The recent global IMbrave150 study evaluated the combination of atezolizumab and
bevacizumab versus sorafenib in 501 patients with advanced or metastatic Hepatocellular
Carcinoma (HCC). The median overall survival (OS) was notably better in the
atezolizumab/bevacizumab group. However, for HCC patients with intrahepatic macrovascular
invasion (MVI), the prognosis remains poor, indicating a significant unmet need in this
group.
External Beam Radiotherapy (EBRT) has shown promising results in treating HCC with MVI,
especially when used in combination with trans-arterial chemoembolization (TACE). It has
been reported that radiotherapy may make tumor cells more susceptible to immune-mediated
therapy, potentially enhancing the effects of atezolizumab and bevacizumab.
Thus, this study aims to investigate the efficacy and safety of atezolizumab/bevacizumab
alone versus atezolizumab/bevacizumab in combination with EBRT in HCC patients with
macrovascular invasion.
Detailed description:
A total of 138 subjects are randomly assigned to one of two treatment groups (69 patients
in the atezolizumab+bevacizumab group and 69 patients in the Atezolizumab plus
Bevacizumab combined EBRT group).
- Radiotherapy combination:
- Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21day cycle.
- Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21day cycle.
- The external beam radiotherapy will commence after day 2 of the first cycle of
Atezolizumab+Bevacizumab, and will be delivered in accordance with
institutional protocol.
- Atezolizumab+Bevacizumab:
- Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21day cycle.
- Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21day cycle.
Additional study identifiers: This study was also registered on the WHO's International
Clinical Trials Registry Platform, CRIS, before the first participant was enrolled (ID:
KCT0007365, Date of registration: 2022-06-08).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Older than 19 years of age, lower than 80 years of age
- Child-Pugh class A hepatic function
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
- Patients with HCC [diagnosed according to AASLD guidelines] invading the
intrahepatic vascular system
- No prior systemic therapy for HCC
- At least one measurable HCC lesion with ≥ 1cm diameter
- Adequate hematologic and organ function
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1,000 /mm3
- Platelet ≥ 50,000/ mm3 without transfusion
- Total bilirubin ≤ 2.5 mg/dL
Exclusion Criteria:
- Treatment history of prior systemic treatment of HCC
- Liver transplant recipients
- Patients with peptic ulcer, untreated or incompletely treated varices with bleeding
or high-risk for bleeding
- Any serious illness (e.g., active infection or inflammatory condition) or
uncontrolled severe medical comorbidity
- A history of treated malignancy (other than HCC) is allowable if the patient's
malignancy has been in complete remission, off chemotherapy and without additional
surgical intervention, during the preceding two years
- Abdominal/pelvic radiotherapy within 28 days prior to initiation of study treatment,
except palliative radiotherapy to bone lesions within 7 days prior to initiation of
study treatment
Gender:
All
Minimum age:
20 Years
Maximum age:
79 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Ju Hyun Shim
Start date:
October 22, 2022
Completion date:
March 2026
Lead sponsor:
Agency:
Asan Medical Center
Agency class:
Other
Collaborator:
Agency:
Seoul National University Hospital
Agency class:
Other
Collaborator:
Agency:
Hanyang University
Agency class:
Other
Collaborator:
Agency:
Soon Chun Hyang University
Agency class:
Other
Source:
Asan Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05992220
