drugset / Trial / NCT06904183
Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT
Phase 2
Recruiting
320 enrolled
Second Affiliated Hospital of Guangzhou Medical University
Affiliated Hospital of Guangdong Medical University · collabAnqing Municipal Hospital · collabFirst People's Hospital of Foshan · collabGuangzhou Development District Hospital · collabHuizhou Municipal Central Hospital · collabJieyang People's Hospital · collabJinan University Affiliated Shunde Hospital · collabZhongshan People's Hospital, Guangdong, China · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE (LEN+SIN+DEB-TACE) for large hepatocellular carcinoma (\> 7cm) with portal vein tumor thrombosis (PVTT).
Timeline
- Start
- 2025-04-01
- Primary completion
- 2029-03-31
- Completion
- 2030-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leucovorin | Small molecule | — | Other |
| Subject | Oxaliplatin | Small molecule | — | Other |
| Subject | fluorouracil | Small molecule | — | Other |
| Background | Lenvatinib | Small molecule | 8 mg | Oral |
| Background | Lenvatinib | Small molecule | 12 mg | Oral |
| Background | Pirarubicin | Small molecule | — | — |
| Background | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |