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This study will evaluate the efficacy and safety of atezolizumab plus bevacizumab combined with on-demand TACE compared to on-demand TACE alone in participants with hepatocellular carcinoma who are at high risk of poorer outcome following TACE treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: atezolizumab + bevacizumab + TACE | Experimental | Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure. |
|
| Arm B: TACE alone | Active Comparator | Participants will receive on-demand transarterial chemoembolization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until participant experience loss of clinical benefit as evaluated by the investigator or unacceptable toxicity or withdrawal of informed consent. |
| Measure | Description | Time Frame |
|---|---|---|
| TACE Progression-Free Survival (TACE PFS) as Determined by Investigator | TACE PFS is defined as the time from randomization to untreatable progression or TACE failure/refractoriness or any cause of death, whichever occurs first, as determined by the investigator (INV). | Randomization to untreatable progression or TACE failure/refractoriness or death (up to approximately 46 months) |
| Overall Survival (OS) | Overall survival (OS) after enrollment is defined as the time from randomization to death from any cause. | Randomization to death from any cause (up to approximately 94 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Untreatable (unTACEable) Progression (TTUP) as Determined by Investigator | INV-assessed TTUP is defined as time from randomization to untreatable (unTACEable) progression, as determined by investigator. | Randomization to untreatable (unTACEable) progression (up to approximately 46 months) |
| Time to Progression (TTP) as Determined by Investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Anhui | 230001 | China | |||
| Peking University First Hospital |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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|
| Becavizumab | Drug | Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle. |
|
|
| Transarterial chemoembolization (TACE) | Device | TACE will be performed by clinical demand. |
|
INV-assessed TTP is defined as the time from randomization to unTACEable progression or TACE failure/refractoriness (as defined above), as determined by investigator. |
| Randomization to unTACEable progression or TACE failure/refractoriness (up to approximately 46 months) |
| Time to Extrahepatic Spread (EHS) as Determined by Investigator | INV-assessed time to EHS is defined as the time from randomization to the first evidence of EHS, as determined by investigator. | Randomization to first evidence of EHS (up to approximately 46 months) |
| Objective Response Rate (ORR), as Determined by Investigator | Objective response (OR) is defined as a complete or partial response, as determined by investigator. | Randomization up to approximately 46 months |
| Duration of Responses (DOR) as Determined by Investigator | INV-assessed DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by INV. | First occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first)(up to approximately 46 months) |
| Progression Free Survival (PFS) | Progression free survival (PFS) is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. | Randomization to first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 94 monthsJ) |
| Time to Deterioration (TTD) | TTD is defined as the time from randomization to first deterioration in the patient-reported GHS/QoL, physical function, or role function scales of the EORTC QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks. | Randomization to first deterioration (up to approximately 94 months) |
| Percentage of Participants With Adverse Events | Baseline up to approximately 94 months |
| Beijing |
| 100034 |
| China |
| Peking University People's Hospital | Beijing | 100044 | China |
| Beijing You An Hospital | Beijing | 100069 | China |
| Beijing Tsinghua Changgung Hospital | Beijing | 102218 | China |
| Hunan Cancer Hospital | Changsha | 410013 | China |
| West China Hospital, Sichuan University | Chengdu | China |
| The First Affiliated Hospital, Chongqing Medical University | Chongqing | 400016 | China |
| Southwest Hospital , Third Military Medical University | Chongqing | 400038 | China |
| The 900th Hospital of PLA joint service support force | Fuzhou | 110016 | China |
| The First Affiliated Hospital Of Fujian Medical University | Fuzhou | 350005 | China |
| Fujian Cancer Hospital | Fuzhou | 350014 | China |
| Mengchao Hepatobiliary Hospital Of Fujian Medical University | Fuzhou | 350025 | China |
| Sun Yet-sen University Cancer Center | Guangzhou | 510060 | China |
| Nanfang Hospital, Southern Medical University | Guangzhou | 510515 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Jiangsu Cancer Hospital | Nanjing | 210009 | China |
| Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) | Nanjing | 210029 | China |
| Guangxi Cancer Hospital of Guangxi Medical University | Nanning | 530021 | China |
| The First Affiliate Hospital of Guangxi Medical University | Nanning | 530021 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| Renji Hospital Shanghai Jiaotong University School of Medicine | Shanghai | 200127 | China |
| Zhongshan Hospital Fudan Unvierstiy | Shanghai | China |
| Shengjing Hospital of China Medical University | Shenyang | 110004 | China |
| Tianjin Cancer Hospital | Tianjin | 300060 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| Xi'an Inernational Medical Center Hospital | Xi'an | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| Zhuhai People's Hospital | Zhuhai | 519099 | China |
| Aichi Cancer Center | Aichi | 464-8681 | Japan |
| Chiba University Hospital | Chiba | 260-8677 | Japan |
| Kurume University Hospital | Fukuoka | 830-0011 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| Yokohama City University Medical Center | Kanagawa | 232-0024 | Japan |
| Kanagawa Cancer Center | Kanagawa | 241-8515 | Japan |
| Kitasato University Hospital | Kanagawa | 252-0375 | Japan |
| The University of Osaka Hospital | Osaka | 565-0871 | Japan |
| Kindai University Hospital | Osaka | 589-8511 | Japan |
| Toranomon Hospital | Tokyo | 105-8470 | Japan |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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