Entry Detail
| General information | |
| Database: | DB00122 |
| Objective: | Secondline treatment options in advanced hepatocellular carcinoma (hepatocellular carcinoma) are limited. Axitinib merits exploration in hepatocellular carcinoma. |
| Authors: | McNamara MG, et al |
| Title: | a phase II trial of secondline axitinib following prior antiangiogenic therapy in advanced hepatocellular carcinoma. |
| Journal: | Cancer. |
| Year: | 2015 |
| PMID: | 25565269 |
| Trial Design | |
| Clinical Trial Id: | NCT01334112 |
| Agent: | axitinib |
| Target: | Macrophage colonystimulating factor 1 Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| 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 singlearm, openlabelphase II study employingSimon¡¯s optimum IIstage design |
| Key Patients Feature: | patients were ChildPugh A/B7, with measurable progressive disease after TKIs/antiangiogenic drugs |
| Biomarker: | AFP(alphafetoprotein) |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Axitinib was started at 5 mg twice daily orally, titrated from 2 to 10 mg twice daily as tolerated. |
| Primary End Point: | tumor control at 16 weeks by RECIST1.1 |
| Secondary End Point: | response rate, comparing response by RECIST1.1 to Choi and modified RECIST, exploring dynamic contrastenhanced imaging models, safety, PFS, and OS. |
| Patients Number: | 30 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | there were 3 partial responses (PR) per RECIST1.1; 13 PR by Choi, 6 PR and 1 complete response by modified RECIST. Tumor control rate at 16 weeks was 42.3%. Twoweek perfusion changes were noted on functional imaging. Of 21 patients with evaluable ¦Áfetoprotein response, 43% had >50% decrease from baseline. |
| Disease Control Rate: | Of 11 patients with any grade hypertension, 7 had disease control >36 wks. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.6 |
| Median OS A vs. C: | 7.1 |
| Adverse Event(agent arm): | Most common axitinibrelated grade 3/4 adverse events (AEs) were hypertension, thrombocytopenia and diarrhea.Four patients discontinued treatment due to AEs. |
| Conclusions: | With 42.3% tumor control at 16 weeks, primary endpoint was met. Axitinib has shown encouraging tolerable clinical activity in VEGFpretreated hepatocellular carcinoma patients but further study should be in a selected population incorporating potential biomarkers of response. |