JPRN-jRCT2080223820
Completed
Phase 3
A phase III, open-label, randomized study of atezolizumab in combination with bevacizumab compared with sorafenib in patients with untreated locally advanced or metastatic hepatocellular carcinoma
ConditionsHepatocellular carcinoma
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hepatocellular carcinoma
- Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Enrollment
- 501
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The safety profile of the combination treatment regimen of Atezolizumab plus Bevacizumab was consistent with the known safety profiles of each individual study drugs and the underlying disease. A clinically meaningful improvement in both OS and PFS based on IRF-assessment was observed with Atezolizumab plus Bevacizumab over Sorafenib.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
- •\- No prior systemic therapy for HCC
- •\- 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
- •\- 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
- •\- Patients with untreated or incompletely treated varices with bleeding or high\-risk for bleeding
- •\- Moderate or severe ascites
- •\- History of hepatic encephalopathy
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular CarcinomaCarcinoma, HepatocellularNCT03434379Hoffmann-La Roche558
Completed
Phase 3
A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)Non-small Cell Lung Cancer (NSCLC)NCT04513925Hoffmann-La Roche829
Completed
Phase 3
A Study of Bevacizumab, Carboplatin, and Paclitaxel or Pemetrexed With or Without Atezolizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (IMpower151)Carcinoma, Non-Small-Cell LungNCT04194203Hoffmann-La Roche305
Active, not recruiting
Phase 3
A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular CarcionmaHepatocellular CarcinomaNCT04712643Hoffmann-La Roche342
Completed
Phase 3
Atezolizumab With Bevacizumab and Chemotherapy vs Bevacizumab and Chemotherapy in Early Relapse Ovarian CancerRecurrent Ovarian CarcinomaNCT03353831AGO Research GmbH574