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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07483359 | Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus | PHASE2 | RECRUITING | 38 | — | — | May 20, 2026 | May 1, 2028 | May 28, 2026 | 1 | China |
The percentage of participants whose disease converts from initially unresectable to technically resectable, as evaluated by a Blinded Independent Review Committee (IRC) based on multimodal radiological imaging. The criteria for successful conversion include the anatomical feasibility of achieving an R0 resection, the adequacy of the future liver remnant (FLR), and the successful downstaging of the Vp3 portal vein tumor thrombus (PVTT).
| Arm | Type | Description |
|---|---|---|
| HAIC plus lenvatinib and tislelizumab | EXPERIMENTAL | Participants receive a 21-day cycle consisting of intravenous immunotherapy (Tislelizumab), local hepatic arterial infusion chemotherapy (FOLFOX-HAIC), and daily oral targeted therapy (Lenvatinib). |
| Name | Type | Description |
|---|---|---|
| HAIC + Tislelizumab +lenvatinib | COMBINATION_PRODUCT | Tislelizumab: 200 mg administered intravenously each 21-day cycle. FOLFOX-HAIC: Administered every 21 days for up to a maximum of 6 cycles. The regimen consists of Oxaliplatin 85 mg/m², Leucovorin 400 mg/m², and 5-Fluorouracil 2500 mg/m² given as a continuous hepatic arterial infusion over 46-48 hours. Lenvatinib: Administered orally once daily on a continuous basis. Dosing is weight-adjusted: 12 mg/day for patients weighing ≥60 kg, and 8 mg/day for patients weighing \<60 kg. |
Inclusion Criteria: Participants must meet all of the following inclusion criteria to be enrolled in this trial: 1. Voluntarily sign the written informed consent form. 2. Age 18 to 80 years (inclusive), male or female. 3. Histologically or cytologically confirmed Hepatocellular Carcinoma (HCC) acc...