| General information |
| Database: | DB00109 |
| Objective: | To assess the efficacy and safety of the antiVEGF receptor2 (VEGFR2) antibody ramucirumab as firstline therapy in patients with advanced hepatocellular carcinoma and explore potential circulating biomarkers. |
| Authors: | Zhu AX, et al |
| Title: | a phase II and biomarker study of ramucirumab, a human monoclonal antibody targeting the VEGF receptor2, as firstline monotherapy in patients with advanced hepatocellular cancer. |
| Journal: | Clin Cancer Res |
| Year: | 2013 |
| PMID: | 24088738 |
| Trial Design |
| Clinical Trial Id: | NCT01140347 |
| Agent: | ramucirumab
|
| Target: | Vascular endothelial growth factor receptor 2
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma not amenable to surgical or regional therapies |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II Study |
| Key Patients Feature: | Adults with advanced hepatocellular carcinoma and no prior systemic treatment |
| Biomarker: | serum biomarker: After treatment with ramucirumab, there was an increase in serum VEGF and placental growth factor (PlGF) and a transient decrease in soluble VEGFR2. |
| Biomark Analysis: | After treatment with ramucirumab, there was an increase in serum VEGF and placental growth factor (PlGF) and a transient decrease in soluble VEGFR2. |
| Control Group Info: | single arm |
| Treatment Info: | pts received ramucirumab 8 mg/kg every two weeks until disease progression or limiting toxicity |
| Primary End Point: | PFS; |
| Secondary End Point: | objective response rate (ORR) and overall survival (OS). |
| Patients Number: | 42 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 9.5% (95% CI, 2.722.6; 4/42 patients had a partial response |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4 months, 95%(CI), 2.65.7 |
| Median OS A vs. C: | 12.0(95% CI, 6.119.7);for patients with Barcelona Clinic Liver Cancer (BCLC) stage C disease, median OS was 4.4 months (95% CI, 0.59.0);for patients with ChildPugh B cirrhosis versus 18.0(95% CI, 6.123.5) for patients with ChildPugh A cirrhosis. |
| Adverse Event(agent arm): | Treatmentrelated grade more than and equal to 3 toxicities included hypertension (14%), gastrointestinal hemorrhage and infusionrelated reactions (7% each), and fatigue (5%). There was one treatmentrelated death (gastrointestinal hemorrhage). |
| Conclusions: | Ramucirumab monotherapy may confer anticancer activity in advanced hepatocellular carcinoma with an acceptable safety profile. Exploratory biomarker studies showed changes in circulating VEGF, PlGF, and sVEGFR2 that are consistent with those seen with other antiVEGF agents. |