Table 2.
Baseline Characteristics of Patients in the Phase II Study
| Characteristic | No. of Patients | % |
|---|---|---|
| Total No. of patients | 42 | 100 |
| Sex | ||
| Male | 38 | 90 |
| Female | 4 | 10 |
| Age, years | ||
| Median | 57.5 | |
| Range | 35-76 | |
| ECOG performance status | ||
| 0 | 24 | 57 |
| 1 | 18 | 43 |
| Positive hepatitis status | ||
| Hepatitis B | 35 | 83 |
| Hepatitis C | 0 | 0 |
| Missing | 3 | 7 |
| Child-Pugh grading for cirrhosis | ||
| A | 41 | 98 |
| B | 1 | 2 |
| Baseline AFP > ULN | ||
| Yes | 34 | 81 |
| No | 8 | 19 |
| Tumor burden | ||
| Macroscopic vascular invasion | 5 | 12 |
| Extrahepatic disease | 31 | 74 |
| Prior therapy for HCC of any form | 34 | 81 |
| No. of prior systemic therapies | ||
| 0 | 26 | 62 |
| 1 | 11* | 26 |
| 2 | 4† | 10 |
| 3 | 1‡ | 2 |
| Prior local therapy with or without regional therapy | ||
| Surgery | 15 | 36 |
| Radiofrequency ablation | 3 | 7 |
| Transarterial therapy | 21 | 50 |
| Radiotherapy | 3 | 7 |
| Other prior therapy | 2§ | 5 |
Abbreviations: AFP, alpha fetoprotein; ECOG, Eastern Cooperative Oncology Group; HCC, hepatocellular carcinoma; ULN, upper limit of normal.
Eight patients had single-agent cytotoxic chemotherapy, one had combination cytotoxic chemotherapy, three had antiangiogenic agents, two had unknown type of systemic therapy.
Two patients had two lines of cytotoxic chemotherapy (one line of single-agent cytotoxic chemotherapy and one line of combination cytotoxic chemotherapy), one had one line of single-agent cytotoxic chemotherapy and one line of antiangiogenic agent, and one had one line of combination cytotoxic chemotherapy and one line of unknown agent.
One patient had two lines of cytotoxic chemotherapy (one line of single-agent cytotoxic chemotherapy and one line of combination cytotoxic chemotherapy) and another unknown type of systemic therapy.
Treatment was not specified in these two patients.