TriangleNCT03434379 · CITED IN SOURCE DOCUMENTS
A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2023-10-23
This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Overall Survival (OS) in the Global Population
Progression Free Survival by Independent Review Facility-Assessment (PFS-IRF) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the Global Population
Overall Survival (OS) in the China Population
PFS-IRF Per RECIST v1.1 in the China Population
Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the Global Population
Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the Global Population
ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the Global Population
Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the Global Population
Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population
Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the Global Population
PFS-IRF Per HCC mRECIST in the Global Population
PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the Global Population
Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the Global Population
TTP-IRF Per HCC mRECIST in the Global Population
TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the Global Population
Overall Survival by Baseline AFP in the Global Population
PFS-IRF Per RECIST v1.1 by Baseline AFP in the Global Population
PFS-INV Per RECIST v1.1 by Baseline AFP in the Global Population
Time to Deterioration (TTD) in the Global Population
Number of Participants With Adverse Events (AEs) in the Global Population
Maximum Serum Concentration (Cmax) of Atezolizumab at Cycle 1 in the Global Population
Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the Global Population
Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the China Population
Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the China Population
ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the China Population
Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the China Population
Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the China Population
Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the China Population
PFS-IRF Per HCC mRECIST in the China Population
PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the China Population
Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the China Population
TTP-IRF Per HCC mRECIST in the China Population
TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the China Population
Time to Deterioration (TTD) in the China Population
Number of Participants With Adverse Events (AEs) in the China Population
Maximum Serum Concentration (Cmax) of Atezolizumab in the China Population
Trough Serum Concentration (Cmin) of Atezolizumab in the China Population
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the China Population
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) * No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed, provided that these medications are discontinued prior to randomization. * At least one measurable untreated lesion * ECOG Performance Status of 0 or 1 * Adequate hematologic and end-organ function * For women of childbearing potential: agreement to remain abstinent * For men: agreement to remain abstinent * Child-Pugh class A Exclusion Criteria: * History of leptomeningeal disease * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan * Known active tuberculosis * History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death * Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last dose of sorafenib * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding * A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment. * Moderate or severe ascites * History of hepatic encephalopathy * Co-infection of HBV and HCV * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Uncontrolled tumor-related pain * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Uncontrolled or symptomatic hypercalcemia * Treatment with systemic immunostimulatory agents * Inadequately controlled arterial hypertension * Prior history of hypertensive crisis or hypertensive encephalopathy * Evidence of bleeding diathesis or significant coagulopathy * History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration * Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture * Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses * Local therapy to liver within 28 days prior to initiation of study treatment or non-recovery from side effects of any such procedure * Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator
- intervention Names
- Drug: Atezolizumab
- Drug: Bevacizumab
- label
- Atezolizumab + Bevacizumab
- type
- EXPERIMENTAL
- description
- Participants will receive Sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator
- intervention Names
- Drug: Sorafenib
- label
- Sorafenib
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Atezolizumab + Bevacizumab
- description
- Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle
- name
- Atezolizumab
- type
- DRUG
- arm Group Labels
- Atezolizumab + Bevacizumab
- description
- Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle
- name
- Bevacizumab
- type
- DRUG
- arm Group Labels
- Sorafenib
- description
- Sorafenib will be administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle
- name
- Sorafenib
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 558
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- OS was defined as the time from randomization to death from any cause.
- measure
- Overall Survival (OS) in the Global Population
- time Frame
- From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)
- description
- PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
- measure
- Progression Free Survival by Independent Review Facility-Assessment (PFS-IRF) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the Global Population
- time Frame
- Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
- description
- OS was defined as the time from randomization to death from any cause.
- measure
- Overall Survival (OS) in the China Population
- time Frame
- From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)
- description
- PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
- measure
- PFS-IRF Per RECIST v1.1 in the China Population
- time Frame
- Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
- secondary Outcomes
- description
- ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
- measure
- Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the Global Population
- time Frame
- Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
- description
- ORR was defined as the percentage of participants with CR or PR as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver measuring only the residual vital tumor mass in the liver. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
- measure
- Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the Global Population
- time Frame
- Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
- description
- ORR was defined as the percentage of participants with CR or PR as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
- measure
- ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the Global Population
- time Frame
- Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
- description
- DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
- measure
- Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the Global Population
- time Frame
- Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
- description
- DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
- measure
- Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population
- time Frame
- Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
- description
- DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
- measure
- Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the Global Population
- time Frame
- Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
- description
- PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
- measure
- PFS-IRF Per HCC mRECIST in the Global Population
- time Frame
- Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
- description
- PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
- measure
- PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the Global Population
- time Frame
- Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
- description
- Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
- measure
- Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the Global Population
- time Frame
- Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
- description
- Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
- measure
- TTP-IRF Per HCC mRECIST in the Global Population
- time Frame
- Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
- description
- Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
- measure
- TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the Global Population
- time Frame
- Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
- description
- OS was defined as the time from randomization to death from any cause. Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
- measure
- Overall Survival by Baseline AFP in the Global Population
- time Frame
- From randomization to death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Full study description
- brief Summary
- This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.
- detailed Description
- The participants will be randomized in a 2:1 ratio to one of the two treatment arms: Arm A (experimental arm): Atezolizumab +bevacizumab; Arm B (control arm): Sorafenib
Source references
- references
- citation
- Xu XQ, Li WM, Shi LC, Wang H, Li S, Huang C, You H, Jia JD, He YW, Kong YY. Impact of temporary atezolizumab and bevacizumab interruption on survival in advanced HCC: an IMbrave150 analysis. Oncologist. 2025 Sep 1;30(9):oyaf269. doi: 10.1093/oncolo/oyaf269.
- pmid
- 40891895
- type
- DERIVED
- citation
- Gao Y, Cheng AL, Li LX, Parent N, Kichenadasse G, Karapetis CS, Rowland A, Hopkins AM, Sorich MJ. Evaluation of hyperprogressive disease with atezolizumab plus bevacizumab for hepatocellular carcinoma: A secondary analysis of the IMbrave150 trial. Int J Cancer. 2025 Jul 15;157(2):336-344. doi: 10.1002/ijc.35407. Epub 2025 Mar 13.
- pmid
- 40079683
- type
- DERIVED
- citation
- Kaseb AO, Guan Y, Gok Yavuz B, Abbas AR, Lu S, Hasanov E, Toh HC, Verret W, Wang Y. Serum IGF-1 Scores and Clinical Outcomes in the Phase III IMbrave150 Study of Atezolizumab Plus Bevacizumab versus Sorafenib in Patients with Unresectable Hepatocellular Carcinoma. J Hepatocell Carcinoma. 2022 Oct 11;9:1065-1079. doi: 10.2147/JHC.S369951. eCollection 2022.
- pmid
- 36254201
- type
- DERIVED
- citation
- Li Y, Liang X, Li H, Chen X. Atezolizumab plus bevacizumab versus nivolumab as first-line treatment for advanced or unresectable hepatocellular carcinoma: A cost-effectiveness analysis. Cancer. 2022 Nov 15;128(22):3995-4003. doi: 10.1002/cncr.34457. Epub 2022 Sep 16.
- pmid
- 36111952
- type
- DERIVED
- citation
- Cheng AL, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Lim HY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Ma N, Nicholas A, Wang Y, Li L, Zhu AX, Finn RS. Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma. J Hepatol. 2022 Apr;76(4):862-873. doi: 10.1016/j.jhep.2021.11.030. Epub 2021 Dec 11.
- pmid
- 34902530
- type
- DERIVED
- citation
- Salem R, Li D, Sommer N, Hernandez S, Verret W, Ding B, Lencioni R. Characterization of response to atezolizumab + bevacizumab versus sorafenib for hepatocellular carcinoma: Results from the IMbrave150 trial. Cancer Med. 2021 Aug;10(16):5437-5447. doi: 10.1002/cam4.4090. Epub 2021 Jun 29.
- pmid
- 34189869
- type
- DERIVED
- citation
- Galle PR, Finn RS, Qin S, Ikeda M, Zhu AX, Kim TY, Kudo M, Breder V, Merle P, Kaseb A, Li D, Mulla S, Verret W, Xu DZ, Hernandez S, Ding B, Liu J, Huang C, Lim HY, Cheng AL, Ducreux M. Patient-reported outcomes with atezolizumab plus bevacizumab versus sorafenib in patients with unresectable hepatocellular carcinoma (IMbrave150): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Jul;22(7):991-1001. doi: 10.1016/S1470-2045(21)00151-0. Epub 2021 May 27.
- pmid
- 34051880
- type
- DERIVED
- citation
- Wen F, Zheng H, Zhang P, Liao W, Zhou K, Li Q. Atezolizumab and bevacizumab combination compared with sorafenib as the first-line systemic treatment for patients with unresectable hepatocellular carcinoma: A cost-effectiveness analysis in China and the United states. Liver Int. 2021 May;41(5):1097-1104. doi: 10.1111/liv.14795. Epub 2021 Feb 8.
- pmid
- 33556230
- type
- DERIVED
- citation
- Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.
- pmid
- 32402160
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- trolled HCC trial. Hepatocellular Carcinoma IMbrave150 The efficacy of intravenous atezolizumab in combination with bevacizumab was investigated in IMbrave150 (NCT03434379), a multicenter, international, open-label, randomized trial in patients with locally advanced unresectable and/or metastatic hepatocellular carcinoma who have
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- oneal Cancer in Study GOG-0213 Figure 9 14.10 Hepatocellular Carcinoma The efficacy of Avastin in combination with atezolizumab was investigated in IMbrave150 (NCT03434379), a multicenter, international, open-label, randomized trial in patients with locally advanced unresectable and/or metastatic hepatocellular carcinoma who have
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Preserved source evidence · Not medical advice