Table 1.
Patients’ baseline characteristics
| Cohort 1 | Cohort 2 | Cohort 3 | Total (range or %) | |
|---|---|---|---|---|
| 5-FU dose (mg/m2) | 250 | 350 | 450 | |
| Number of patients | 3 | 3 | 6 | 12 |
| Age or median age (range) (years) | 64, 74, 65 | 74, 49, 55 | 65 (54–75) | 65 (49–75) |
| Sex: male, female | 3, 0 | 3, 0 | 6, 0 | 12, 0 (100, 0%) |
| ECOG status: 0, 1 | 3, 0 | 3, 0 | 6, 0 | 12, 0 (100, 0%) |
| Etiology: HBV, HCV, others | 1, 0, 2 | 2, 0, 1 | 1, 2, 3 | 4, 2, 6 (33.3, 16.7, 50%) |
| Radiological features (CT) | ||||
| Median tumor diameter (cm) | 5 (1.3–7.3) | 7.9 (2.5–9.6) | 6.8 (1.0–9.1) | 6.8 (1.0–9.6) |
| Portal invasion | 0 | 0 | 1 (segmental) | 1 (8.3%) |
| UICC stage | ||||
| I–II | 0 | 0 | 0 | 0 |
| III | 0 | 0 | 1 | 1 (8.3%) |
| IV-A | 0 | 0 | 0 | 0 |
| IV-B | 3 | 3 | 5 | 11 (91.7%) |
| Location of metastases | ||||
| Lung | 2 | 2 | 1 | 5 (41.7%) |
| Lymph node | 1 | 2 | 3 | 6 (50%) |
| Bone | 1 | 1 | 1 | 3 (25%) |
| Others | 1 | 1 | 1 | 3 (25%) |
| Median AFP (ng/mL) | 4.2 (3.0–5931.2) | 191.8 (4.0–571.0) | 20.8 (5.2–126.0) | 20.8 (3.0–5931.2) |
| Median PIVKA-II (mAU/mL) | 2130 (763–23,199) | 11500 (19–42,522) | 2480 (23–110,648) | 2130 (19–110,648) |
| Prior treatments | ||||
| None | 1 | 1 | 3 | 5 (41.7%) |
| Surgery | 1 | 0 | 2 | 3 (25%) |
| Ablation therapy | 0 | 0 | 0 | 0 |
| TACE | 1 | 2 | 0 | 3 (25%) |
| HAIC | 0 | 0 | 1 | 1 (8.3%) |
5-FU 5-fluorouracil, AFP alpha-fetoprotein, CT computed tomography, ECOG Eastern Cooperative Oncology Group, HAIC hepatic arterial infusion chemotherapy, HBV hepatitis B virus, HCV hepatitis C virus, PIVKA-II protein induced by vitamin K absence or antagonist II, TACE transcatheter arterial chemoembolization, TNM tumor, node, metastasis, UICC Union for International Cancer Control