| General information |
| Database: | DB00938 |
| 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 cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II and biomarker study |
| Key Patients Feature: | Adults with advanced hepatocellular carcinoma and no prior systemic treatment |
| Biomarker: | Circulating biomarkers were evaluated before and after ramucirumab treatment in a subset of patients |
| 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: | progression free survival (PFS); |
| Secondary End Point: | objective response rate (ORR) and overall survival (OS). |
| Patients Number: | 42 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 9.50% |
| Disease Control Rate: | 69.0% (95% CI, 52.9-82.4) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.0 months [95% confidence interval (CI), 2.65.7] |
| Median OS A vs. C: | 12.0 months (95% CI, 6.119.7). |
| Adverse Event(agent arm): | AEs considered possibly, probably or definitely related to ramucirumab are shown in Table 2. Treatmentrelated grade 3-5 AEs were observed in 14 patients (33%). The most common treatmentrelated grade more than and equal to 3 AEs included hypertension (6 patients, 14%), gastrointestinal hemorrhage and infusionrelated reactions (3 patients, 7%, each), and fatigue (2 patients, 5%). One treatmentrelated death (grade 5, 2%) occurred from gastrointestinal hemorrhage (esophageal varices). |
| 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 |