scholarly journals Phase II, open-label study of brivanib as first-line therapy in patients with advanced hepatocellular carcinoma

2012 ◽  
Vol 56 (2) ◽  
pp. 486-487 ◽  
Author(s):  
Jairo A. Garcia ◽  
Lewis R. Roberts
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase Ii ◽  
Advanced Hepatocellular Carcinoma ◽  
First Line ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
First Line Therapy ◽  
Line Therapy

scholarly journals Phase II, Open-Label Study of Brivanib as First-Line Therapy in Patients with Advanced Hepatocellular Carcinoma

2011 ◽  
Vol 17 (7) ◽  
pp. 1973-1983 ◽  
Author(s):  
Joong-Won Park ◽  
Richard S. Finn ◽  
Jun Suk Kim ◽  
Mark Karwal ◽  
Ruby K. Li ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase Ii ◽  
Advanced Hepatocellular Carcinoma ◽  
First Line ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
First Line Therapy ◽  
Line Therapy

Donafenib versus sorafenib as first-line therapy in advanced hepatocellular carcinoma: An open-label, randomized, multicenter phase II/III trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4506-4506 ◽  
Author(s):  
Feng Bi ◽  
Shukui Qin ◽  
Shanzhi Gu ◽  
Yuxian Bai ◽  
Zhendong Chen ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase Ii ◽  
Objective Response ◽  
Advanced Hepatocellular Carcinoma ◽  
First Line ◽  
Open Label ◽  
Multikinase Inhibitor ◽  
First Line Therapy ◽  
Line Therapy ◽  
Number Of Patients

4506 Background: Sorafenib is still the standard first-line therapy for advanced hepatocellular carcinoma (HCC). Donafenib, a novel multikinase inhibitor, showed potential benefits in a previous phase Ib study in HCC. Methods: In this open-label, randomized phase II/III trial (ZGDH3), patients with unresectable or metastatic HCC, a Child-Pugh liver function score ≤ 7, and no prior systemic therapy were enrolled from 37 sites across China and randomized (1:1) to receive oral donafenib (0.2 g) or sorafenib (0.4 g) twice daily until intolerable toxicity or disease progression. The primary endpoint was overall survival (OS). Efficacy analysis was primarily based on the full analysis set (FAS). Results: Between March 2016 and April 2018, 668 patients were randomized (donafenib, 334; sorafenib, 334) and included in the intention-to-treat (ITT) set, of whom 659 were analysed by FAS (328 vs 331). Donafenib was associated with a significantly longer median OS than sorafenib in both FAS (12.1 months vs 10.3 months, hazard ratio 0.831, 95% confidence interval 0.699–0.988, p = 0.0363) and ITT (12.0 months vs 10.1 months, 0.839, 0.706–0.996, p = 0.0446). There were no significant differences in median progression-free survival (3.7 months vs 3.6 months, p = 0.2824), objective response rate (4.6% vs 2.7%, p = 0.2448), and disease control rate (30.8% vs 28.7%, p = 0.5532). Grade 3 or worse adverse events (AEs) occurred in 191 (57.4%) and 224 (67.5%) patients ( p = 0.0082), respectively, and AEs of special interest and those leading to treatment interruption occurred in 287 (86.2%) vs 309 (93.1%, p = 0.0049) and 101 (30.3%) vs 141 (42.5%, p = 0.0013). A numerically lower number of patients reported serious AEs (55 [16.5%] vs 67 [20.2%], p = 0.2307) with donafenib. Common AEs with donafenib included hand-foot skin reaction (50.5%), aspartate aminotransferase increased (40.5%), blood bilirubin increased (39.0%), platelet count decreased (37.8%), and diarrhea (36.6%). Conclusions: Donafenib significantly improves OS over sorafenib with favourable safety and tolerability. Donafenib is a promising superior first-line therapy for advanced HCC. Funding: Zelgen. Clinical trial information: NCT02645981 .

Phase II, Open-Label Study of Brivanib as Second-Line Therapy in Patients with Advanced Hepatocellular Carcinoma

2012 ◽  
Vol 18 (7) ◽  
pp. 2090-2098 ◽  
Author(s):  
Richard S. Finn ◽  
Yoon-Koo Kang ◽  
Mary Mulcahy ◽  
Blase N. Polite ◽  
Ho Yeong Lim ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase Ii ◽  
Advanced Hepatocellular Carcinoma ◽  
Second Line ◽  
Open Label ◽  
Second Line Therapy ◽  
Open Label Study ◽  
Label Study ◽  
Line Therapy

scholarly journals Bevacizumab with Erlotinib as First-line Therapy in Asian Patients with Advanced Hepatocellular Carcinoma: A Multicenter Phase II Study

Oncology ◽  
2013 ◽  
Vol 85 (1) ◽  
pp. 44-52 ◽  
Author(s):  
Chih-Hung Hsu ◽  
Yoon Koo Kang ◽  
Tsai-Shen Yang ◽  
Chia-Tung Shun ◽  
Yu-Yun Shao ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Advanced Hepatocellular Carcinoma ◽  
First Line ◽  
First Line Therapy ◽  
Asian Patients ◽  
Multicenter Phase ◽  
Line Therapy
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