drugset / Trial / NCT07483359
Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus
Phase 2
Recruiting
38 enrolled
First Hospital of China Medical University
Liaoning Cancer Hospital & Institute · collabThe Affiliated Hospital of Yanbian University · collab
NaSingle-groupOpen-labelTreatment
Summary
Patients with hepatocellular carcinoma (HCC) complicated by Vp3 portal vein tumor thrombus (PVTT) face a poor prognosis and are typically ineligible for surgical resection. This prospective study evaluates a conversion therapy regimen-utilizing a combination of FOLFOX-HAIC, Lenvatinib, and Tislelizumab-designed to induce significant regression of both the tumor burden and the PVTT. The primary objective is to determine the Technical Resectability Rate (TRR), assessing the potential for this triple-combination therapy to downstage initially unresectable disease to a state suitable for curative-intent R0 surgical resection.
Timeline
- Start
- 2026-05-20
- Primary completion
- 2027-06
- Completion
- 2028-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 8 mg | Oral |
| Subject | Lenvatinib | Small molecule | 12 mg | Oral |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Other |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Other |
| Background | fluorouracil | Small molecule | 2500 mg/m2 | Other |