drugset / Trial / NCT06364007
HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC
NaSingle-groupOpen-labelTreatment
Summary
The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with unresectable HCC. In Asian region, HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment. Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib. This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib, given concurrently with HAIC in pts with unresectable HCC.
Timeline
- Start
- 2024-03-03
- Primary completion
- 2025-12-31
- Completion
- 2026-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | — |
| Subject | Lenvatinib | Small molecule | 8 mg | — |
| Subject | Lenvatinib | Small molecule | 12 mg | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Tremelimumab | Monoclonal antibody | 300 mg | — |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | — |
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |