Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05040438 | Natural Killer (NK) Cell Therapy in Locally Advanced HCC | PHASE2 | COMPLETED | 17 | — | — | Oct 15, 2019 | Sep 14, 2023 | Apr 30, 2024 | 1 | South Korea |
ORR will be measured as the proportion of patients with a best overall response of complete response (CR) and partial response (PR) of administering VAX-NK/HCC combined with HAIC.
| Arm | Type | Description |
|---|---|---|
| Autologous NK cell infusion combined with HAIC | EXPERIMENTAL | HAIC of 5-FU (500 mg/m2, Q4W) and cisplatin (15 mg/m2, Q4W) will be administered for up to 4 cycles to patients with locally advanced HCC. Subjects who achieved sustained SD or better based on the mRECIST criteria after 2nd cycle of HAIC will be enrolled to receive 1x10\^9 cells VAX-NK/HCC infusion. |
| Name | Type | Description |
|---|---|---|
| Vax-NK/HCC | BIOLOGICAL | autologous NK cells expanded ex vivo. |
Inclusion Criteria: * Subjects with intermediate and/or locally advanced HCC histologically confirmed by biopsy or by typical radiological findings. * Subjects who were not suitable for or failed curative treatments such as surgical resection, local ablation therapy, transarterial chemoembolization...